COVID-19 Diagnostics/Devices Advances News: Weekly Summary · Technology Updates (8) Top . Section...

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Compiled by: https://vaccinewewin.com/covid-19-diagnostics-devices-news-weekly-summary/ Page 1 COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020 The COVID-19 Diagnostics/Devices Advances news updates of last 6 days for global companies, research institutes, academia, and healthcare organizations are comprehensively compiled and summarized here. These news, which are curated from global as well as regional and local news media are also listed out by various sorting here. Section 1 - COVID-19 Diagnostics/Devices Advances News: By Sub-Categories Appendix 1 - COVID-19 Diagnostics/Devices Advances News List: By Region | Appendix 2 - COVID-19 Diagnostics/Devices Advances News List: By Sub-Industry | Appendix 3 - COVID-19 Diagnostics/Devices Advances News List from New Companies in the Fray this Week Sub-Categories Covered Covid-19 Antibody/ Serology Test (12) Covid-19 Test Development (9) Covid-19 Testing Kits/ Facilities/ Sites (12) Forecast/ Research/ Studies/ Reports/ Results (27) Grants/ Investment/ Funding/ Donations (5) Manufacturing Facility/ Production Related (7) Molecular Diagnostics (3) Regulatory Authorization/Approval (14) Technology Updates (8) Top Section 1 - COVID-19 Diagnostics/Devices Advances News: By Sub-Categories Covid-19 Antibody/ Serology Test Abbott Laboratories , United States [ www , ABT , Healthcare Services , LargeCap ] 1: Abbott, Roche ink deals with UK for 10M coronavirus antibody tests - Through deals with Abbott and Roche, the U.K. has secured a supply of more than 10 million tests for “the coming months.” Abbott is supplying “millions” of the tests and has already shipped 800,000 to U.K. laboratories. The U.K. government is still negotiating agreements with other manufacturers with a view to sourcing millions of additional antibody tests. More... (May 22, 2020) [Collaborations] Avacta Group plc , United Kingdom [ www , AVCT , Biotechnology , LargeCap ] 2: Avacta and Medusa19 Enter into a Distribution Agreement for COVID-19 Antigen Test - Avacta Group plc, the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has

Transcript of COVID-19 Diagnostics/Devices Advances News: Weekly Summary · Technology Updates (8) Top . Section...

Page 1: COVID-19 Diagnostics/Devices Advances News: Weekly Summary · Technology Updates (8) Top . Section 1 - COVID-19 Diagnostics/Devices Advances News: By Sub-Categories Covid-19 Antibody

Compiled by: https://vaccinewewin.com/covid-19-diagnostics-devices-news-weekly-summary/ Page 1

COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

The COVID-19 Diagnostics/Devices Advances news updates of last 6 days for global companies, research institutes, academia, and healthcare organizations are comprehensively compiled and summarized here. These news, which are curated from global as well as regional and local news media are also listed out by various sorting here.

Section 1 - COVID-19 Diagnostics/Devices Advances News: By Sub-Categories

Appendix 1 - COVID-19 Diagnostics/Devices Advances News List: By Region | Appendix 2 - COVID-19

Diagnostics/Devices Advances News List: By Sub-Industry | Appendix 3 - COVID-19 Diagnostics/Devices

Advances News List from New Companies in the Fray this Week

Sub-Categories Covered

Covid-19 Antibody/ Serology Test (12)

Covid-19 Test Development (9) Covid-19 Testing Kits/ Facilities/ Sites (12)

Forecast/ Research/ Studies/ Reports/ Results (27)

Grants/ Investment/ Funding/ Donations (5)

Manufacturing Facility/ Production Related (7)

Molecular Diagnostics (3) Regulatory Authorization/Approval (14)

Technology Updates (8)

Top

Section 1 - COVID-19 Diagnostics/Devices Advances News: By Sub-Categories

Covid-19 Antibody/ Serology Test

Abbott Laboratories , United States [ www , ABT , Healthcare Services , LargeCap ] 1: Abbott, Roche ink deals with UK for 10M coronavirus antibody tests - Through deals with Abbott and Roche, the U.K. has secured a supply of more than 10 million tests for “the coming months.” Abbott is supplying “millions” of the tests and has already shipped 800,000 to U.K. laboratories. The U.K. government is still negotiating agreements with other manufacturers with a view to sourcing millions of additional antibody tests. More... (May 22, 2020) [Collaborations]

Avacta Group plc , United Kingdom [ www , AVCT , Biotechnology , LargeCap ] 2: Avacta and Medusa19 Enter into a Distribution Agreement for COVID-19 Antigen Test - Avacta Group plc, the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

entered into an exclusive distribution agreement with Medusa19 Limited for direct-to-consumer sales of a saliva-based rapid test for the COVID-19 antigen. More... (May 20, 2020) [Collaborations]

Biodesix, Inc , United States [ www , Biotechnology , - ] 3: Biodesix Partners with Bio-Rad to Launch a Serology Test to Detect Coronavirus (COVID-19) Antibodies - Biodesix, Inc., a leading diagnostic company in lung disease announced that it has collaborated with Bio-Rad Laboratories, Inc to launch a blood-based immunoassay-based test that identifies antibodies to SARS-CoV-2, the virus that causes COVID-19. The Platelia SARS-CoV-2 Total Ab test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) late last month, making it the first total antibody test to receive EUA from the FDA. More... (May

19, 2020) [Collaborations]

Blanchard Valley Health System , United States [ www , Healthcare Services ] 4: BVHS introduces antibody testing, plasma treatment for COVID-19 - Blanchard Valley Health System announced that it is now offering antibody testing for COVID-19, and can offer convalescent plasma as treatment for inpatient, critically ill, confirmed COVID-19 patients. More... (May 18, 2020) [Treatment Initiatives]

Bronson Health Care Group , United States [ Healthcare Services , - ] 5: Bronson Healthcare launches antibody testing for coronavirus - Bronson Healthcare launched antibody testing to identify patients who have been exposed to COVID-19 but may have been asymptomatic or were not able to get tested. The test is intended to see if the patient was exposed to the virus and has built up some immunity to it. It’s too early to tell if someone who recovered from COVID-19 would have permanent immunity to the virus and not be susceptible to getting infected again More... (May 22, 2020) [Treatment Initiatives]

Centers for Disease Control and Prevention (CDC) , United States [ www , Research Institute ] 6: CDC to Launch Massive Population-based Antibody Testing for SARS-CoV-2 - The Centers for Disease Control and Prevention (CDC) is on the cusp of launching a massive, 25-city SARS-CoV-2 antibody study. Expected to launch in June or July, the study plans to test as many as 325,000 people to learn how the SARS-CoV-2 virus is spreading nationally. More... (May 19, 2020) [Treatment Initiatives]

CPC Diagnostics Pvt Ltd , India [ www , Medical Devices , - ] 7: CPC Diagnostics launches SARS COV-2 IgM, SARS COV-2 IgG tests in India - CPC Diagnostics , a portfolio company of Everstone backed healthcare platform Everlife Holdings has launched SARS COV-2 IgM and SARS COV-2 IgG tests in India. Both are CE-approved antibody tests and are the first of their kind to get approved by the Indian Council of Medical Research (ICMR). More... (May 21, 2020) [Treatment Initiatives]

Duke-NUS Medical School , Singapore [ www , Academic Institution ] 8: New SARS-CoV-2 Test Can Detect Neutralizing Antibodies in an Hour - Researchers at the Duke-NUS Medical School in Singapore have announced a new blood test for neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, and have formed public and private partnerships to begin working toward making the tests clinically available. More... (May 20, 2020) [Treatment Initiatives]

FlowMetric Diagnostics, Inc. , United States [ www , Medical Devices , - ] 9: FlowMetric Diagnostics, Inc. Announces the Expansion of Their Core Services to Include Serological Antibody Testing for SARS-CoV-2 Exposure - FlowMetric Diagnostics, Inc., a division of FlowMetric Life Sciences, Inc. focused on providing immune monitoring testing, announces the expansion of their testing services to include validated serological antibody testing for SARS-CoV-2

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

(COVID-19) exposure. More... (May 21, 2020) [Treatment Initiatives]

Independent General Practice , United Kingdom [ www , Healthcare Services , - ] 10: IGP Launches COVID-19 Antibody Home Tests - The Independent General Practice has collaborated with Infectious Disease Consultant Dr Sharon Marlowe to launch its Covid-19 antibody testing service. In response to the SARS-CoV-2 outbreak, the IGP now offers the at-home test kits, which have 99.6% sensitivity and 100% specificity, for those suspecting they may have had Coronavirus. More... (May 22, 2020) [Collaborations]

PerkinElmer, Inc. , United States [ www , PKI , Biotechnology , MidCap ] 11: SARS-CoV-2 Testing From EUROIMMUN - EUROIMMUN, a PerkinElmer, Inc. company, is one of the first companies in the world to offer a comprehensive panel of SARS-CoV-2 tests, validated for in vitro diagnostic purposes. Tests offered include swabs and polymerase chain reaction (PCR) technologies for direct detection of the virus and high accuracy serology methods (ELISA: enzyme linked immunosorbent assay) for the detection of antibodies in patients that have had a previous COVID-19 infection. More... (May 18, 2020) [Treatment Initiatives]

Todos Medical Ltd , Israel [ www , TOMDF , Biotechnology , SmallCap ] 12: Todos Medical Announces First Commercial Sale of COVID-19 Antibody Tests - Todos Medical Ltd, an in vitro diagnostics company focused on the distribution of a comprehensive suite of solutions for the screening and diagnosis of COVID-19 and the development of blood tests for the early detection of cancer and Alzheimer’s disease announced its first commercial sale of COVID-19 tests. More... (May 18,

2020) [Treatment Initiatives]

Back

Covid-19 Test Development

Aegea Biotechnologies, Inc. , United States [ www , Biotechnology , - ] 13: Aegea Biotechnologies, Inc. Announces The Issuance Of 7 Additional Key U.S. Patents Relating To Its Core, Next Generation Nucleic Acid Clinical Diagnostic Technologies And Covid-19 Test Development - Aegea Biotechnologies, Inc., a biotechnology company focusing on the development and commercialization of next generation nucleic acid clinical diagnostic technologies, announces the issuance of 7 additional key US patents related to its core next generation nucleic acid clinical diagnostic technologies, including applications related to COVID-19 diagnostic testing under the collaboration agreement with Tauriga Sciences, Inc. More... (May 18, 2020) [Collaborations]

Aldeyra Therapeutics Inc , United States [ www , ALDX , Biotechnology , LargeCap ] 14: Aldeyra Therapeutics to Advance ADX-1612, an Investigational New HSP90 Inhibitor with Potential Nanomolar Potency Against SARS-CoV-2, to Clinical Testing for COVID-19; ADX-629 Accepted for BARDA CoronaWatch Meeting - Aldeyra Therapeutics, Inc., a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19, and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases. More... (May 20, 2020) [Treatment Initiatives]

Genetic Technologies Limited , Australia [ www , GTG , Biotechnology , SmallCap ] 15: Genetic Technologies - Accelerated development of new COVID-19 Polygenic Risk Test for Risk of Developing Life-Threatening Complications - Genetic Technologies Limited is to commence accelerating development of a polygenic risk score (PRS) test to predict an individual’s risk of

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

developing life-threatening complications should they become infected with COVID-19. More... (May 20,

2020) [Collaborations]

GlaxoSmithKline plc , United Kingdom [ www , GSK , Pharmaceuticals , LargeCap ] 16: GSK ties up with gene editing start-up Mammoth for COVID-19 test - GlaxoSmithKline's consumer health unit has tied up with Mammoth Biosciences to develop a test that uses a technology commonly used in gene editing to detect novel coronavirus infections. More... (May 20, 2020) [Collaborations]

IberoGEN , Spain [ www , Biotechnology , - ] 17: IberoGEN develops kit to detect coronavirus on surfaces susceptible to contamination - Company IberoGEN at the Miguel Hernández University of Elche (UMH) has developed a test for the early detection of coronavirus on surfaces susceptible to contamination from everyday use, such as handles, railings, switches, telephones, and keyboards, which is intended for comprehensive service companies as well as specialised entities. The test is also valid for detecting the virus in wastewater, an important aspect for controlling outbreaks of COVID-19. More... (May 22, 2020) [Treatment Initiatives]

Oxford Nanopore Technologies Limited , United Kingdom [ www , Biotechnology , - ] 18: Oxford Nanopore Technologies announces advanced development of LamPORE, for rapid, highly scalable, low-cost COVID-19 detection - Oxford Nanopore Technologies is in advanced development of a new generation of end-to-end test (assay) for the detection of SARS-CoV-2, the virus that causes COVID-19. LamPORE is based on Oxford Nanopore’s DNA/RNA sequencing technology, in combination with a simple, sample-preparation method (loop-mediated isothermal amplification, plus Oxford Nanopore’s ‘rapid kit’). It seeks to understand whether a sample currently contains the SARS-CoV-2 virus (rather than detecting antibodies that may indicate a previous infection). More... (May 22,

2020) [Treatment Initiatives]

Pathnostics , United States [ www , Healthcare Services , - ] 19: Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection - Pathnostics, a diagnostic solutions company, announced that it has launched a COVID-19 polymerase chain reaction (PCR) laboratory test designed to support U.S. health care workers in their efforts to keep their patients, colleagues and workplaces safe. The company created the test after hearing from its customers who specialize in emergency, mobile and post-acute health care that they needed access to a test that is easy to administer and adept at identifying people infected with COVID-19. More... (May 20,

2020) [Treatment Initiatives]

Promis Neurosciences Inc , Canada [ www , PMN , Biotechnology , SmallCap ] 20: ProMIS Neurosciences and BC Neuroimmunology expand collaboration to develop and commercialize proprietary diagnostic assay - ProMIS Neurosciences, Inc., a company with unique, core technology to predict novel targets on the molecular surface of complex proteins, announced that, in addition to its ongoing program to develop a high-throughput and accurate test for detection of antibodies to the causative agent of COVID-19, it has expanded its collaboration with BC Neuroimmunology (BCNI) to include development of highly sensitive and specific assays to support accurate screening and diagnosis of Alzheimer’s disease (AD). More... (May 19, 2020) [Collaborations]

University of California, Los Angeles , United States [ www , Academic Institution ] 21: Team to develop Breathalyzer-like diagnostic test for COVID-19 - A research team led by Pirouz Kavehpour, professor of mechanical and aerospace engineering in the UCLA Samueli School of Engineering, is developing an inexpensive and fast Breathalyzer-like diagnostic tool to test for the novel coronavirus that causes COVID-19. More... (May 21, 2020) [Treatment Initiatives]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Back

Covid-19 Testing Kits/ Facilities/ Sites

Accurate Diagnostic Labs Inc. , India [ www , Healthcare Services , - ] 22: Accurate Diagnostic Laboratories Continues to Assist Our Front-Line Workers by Offering Coronavirus Testing for Port Authority/PATH Essential Employees - Accurate Diagnostic Labs, in collaboration with RUCDR Infinite Biologics and Agile Urgent Care, will continue to expand access for active infection testing to vital front-line workers. All New York and New Jersey essential Port Authority/PATH workers will have testing access at locations in East Rutherford, Somerset, and Sewell, NJ. More... (May 21, 2020) [Collaborations]

Cleveland Clinic Florida , United States [ www ] 23: Cleveland Clinic Akron General to Open COVID-19 Testing Site in Akron - Cleveland Clinic Akron General will open a COVID-19 testing location in downtown Akron in mid-June with assistance from the Akron Summit County COVID-19 Emergency Support Fund. United Way of Summit County will provide additional support to families and individuals at the testing site. More... (May 19, 2020) [Treatment

Initiatives]

CVS Health Corp , United States [ www , CVS , Healthcare Services , LargeCap ] 24: CVS Health Expands Statewide COVID-19 Response By Opening 12 Additional New Drive-Thru Test Sites in Massachusetts - In an ongoing effort to help slow the spread of the virus, CVS Health expanded its COVID-19 testing program by announcing 12 additional test sites at select CVS Pharmacy drive-thru locations across Massachusetts. More... (May 21, 2020) [Treatment Initiatives]

25: CVS Health Opens 14 New Drive-Thru Test Sites in California as Part of Nationwide COVID-19 Response - Building on the company's comprehensive efforts to help slow the spread of the virus CVS Health will open 14 new COVID-19 test sites at select CVS Pharmacy drive-thru locations across California. The opening of additional test sites across the state and country will be announced by the end of the month. More... (May 21, 2020) [Treatment Initiatives]

26: CVS Health Opens 44 New Drive-Thru Test Sites in Texas as Part of Nationwide COVID-19 Response - Building on the company's comprehensive efforts to help slow the spread of the virus CVS Health will open 44 new COVID-19 test sites at select CVS Pharmacy drive-thru locations across Texas. The opening of additional test sites across the state and country will be announced by the end of the month. More... (May 21, 2020) [Treatment Initiatives]

Gentueri Inc , United States [ www , Biotechnology , - ] 27: Gentueri Inc. to develop COVID-19 oral testing kits - Gentueri Inc. contributes 55,000 COVID-19 testing kits a week to the state’s lab capacity and is developing new testing kits that can be used in the workplace. More... (May 21, 2020) [Treatment Initiatives]

MagnaCare , United States [ www , Healthcare Services , - ] 28: MagnaCare and BioReference Laboratories Bring COVID-19 Antibody Testing to New York Labor Groups - MagnaCare announced a collaboration with BioReference Laboratories, Inc., an OPKO Health company, to bring COVID-19 antibody testing to their Labor clients in the New York metropolitan area. Through this collaboration with BioReference, MagnaCare will offer on-site antibody blood testing to Labor members, delivering valuable information as the city, employers and individuals plan return-to-work strategies. More... (May 18, 2020) [Collaborations]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Opencell Software , France [ www , Software , - ] 29: OpenCell Partners with King’s College and Opentrons To Create Affordable Shipping Container COVID-19 Testing Lab - Scientists from OpenCell.bio and King's College London, in partnership with Opentrons Labworks, have developed a low-cost rapidly deployable COVID testing lab inside a shipping container that can process 2,400 tests per day. This is the first fully functional lab that can be immediately deployed anywhere in the world for COVID testing. The system uses low-cost liquid handling robots developed by Opentrons Labworks to perform a qPCR (the gold-standard nucleic acid detection test) to detect the presence of the SARS-CoV-2 virus. More... (May 21, 2020) [Collaborations]

Roche Holding AG , Switzerland [ www , RO , Pharmaceuticals , LargeCap ] 30: Roche highly accurate antibody test for COVID-19 goes live at more than 20 initial lab sites in the US - Roche announced its Elecsys® Anti-SARS-CoV-2 antibody test is live at more than 20 commercial and hospital lab sites throughout the United States, with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week. More... (May 19, 2020) [Treatment Initiatives]

Seegene Inc , South Korea [ www , 096530 , Medical Devices , LargeCap ] 31: Seegene readying to bring a new test kit to address COVID-19 mutations - Seegene, a leading developer of multiplex PCR technologies headquartered in South Korea, will soon file for marketing approval of its new COVID-19 test kit that is able to detect even mutations of the virus, the company’s chief executive and founder Chun Jong-yoon said. More... (May 22, 2020) [Research/Studies/Reports/Recognitions]

Sharecare Inc , United States [ www , Healthcare Services , - ] 32: Sharecare and Augusta University forge public-private partnership to accelerate Georgia's recovery from COVID-19 - Sharecare, the digital health company that helps people manage all their health in one place, announced a strategic partnership with Augusta University and Augusta University Health to support Gov. Brian Kemp's efforts to better inform Georgians about the pandemic while bolstering COVID-19 testing across the state. More... (May 23, 2020) [Collaborations]

St. Joseph Mercy Hospital , United States [ www ] 33: St. Joseph Mercy launches $20M COVID-19 testing and treatment centre - The St. Joseph Mercy Hospital (SJMH) announced its launch of a novel coronavirus disease (COVID-19) testing and treatment facility at the St. Paul Retreat Centre at Vryheid’s Lust, on the East Coast of Demerara. The new “COVID-19 Testing, Treatment and Isolation Centre” meets all national criteria for such a facility and was licensed by Guyana’s Ministry of Public Health after a stringent inspection of the premises and evaluation of the services offered. More... (May 23, 2020) [Treatment Initiatives]

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Forecast/ Research/ Studies/ Reports/ Results

23andMe, Inc , United States [ www , Biotechnology , - ] 34: 23 and Me expands COVID-19 genetics study - The 23 and Me genetic service has jumped into research on COVID-19. Since April, it's enlisted 8,000 members who've had the disease, surveying them on their symptoms. But after realizing most of those cases were in the mild to moderate range, 23 and Me decided it needed hospitalized survivors. More... (May 21, 2020) [Research/Studies/Reports/Recognitions]

Abbott Laboratories , United States [ www , ABT , Healthcare Services , LargeCap ] 35: Abbott Releases Interim Clinical Study Data On Id Now Covid-19 Rapid Test Showing Strong Agreement To Lab-Based Molecular Pcr Tests - Abbott announced an interim analysis of an ongoing

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

multi-site clinical study in urgent care clinics that indicates its ID NOW COVID-19 rapid test is showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. The interim results are demonstrating ID NOW COVID-19 test performance is =94.7% in positive agreement (sensitivity) and =98.6% negative agreement (specificity) when compared to two different lab-based PCR reference methods. More... (May 21, 2020) [Research/Studies/Reports/Recognitions]

Aetion, Inc. , United States [ www , Software , - ] 36: Aetion and FDA Team Up for RWE Study to Advance Understanding of COVID-19 - Health tech company Aetion and the U.S. Food and Drug Administration (FDA) signed a collaboration agreement to use real-world data to advance the understanding of and response to COVID-19, the novel coronavirus that continues to sweep across the globe. Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources. More... (May 19, 2020) [Collaborations]

Aladdin Healthcare Technologies SE , United Kingdom [ www , Healthcare Services , - ] 37: Aladdin Healthcare Technologies SE achieves further milestone in COVID-19 drug development: Discovery of 20 new optimized compounds with AI DD platform - Aladdin Healthcare Technologies SE , a leading developer of Artificial Intelligence (AI) based healthcare diagnostics and drug discovery applications, has discovered 20 novel compounds, in partnership with the Sun-Yat Sen University, to combat the coronavirus. Generally, it takes ten years to develop a new drug with a preclinical phase of two to three years. With Aladdin's AI platform, this preclinical phase can be reduced to only twelve months. More... (May 20, 2020) [Collaborations]

Babson Diagnostics, Inc , United States [ www , Healthcare Services , - ] 38: Babson Diagnostics Enters Collaborative Research Agreement with Dell Medical School to Study Immune Response to COVID-19 - Babson Diagnostics, a transformative diagnostic blood testing company, announced it has entered into a collaborative research agreement with Dell Medical School at The University of Texas at Austin (Dell Med) to study the immune response to COVID-19. The announcement follows the recent launch of Babson’s IgG serology test, which yielded 93.2 percent sensitivity and 100.0 percent specificity in its clinical performance evaluation and has been submitted to the FDA for Emergency Use Authorization. More... (May 20, 2020) [Collaborations]

BioAegis Therapeutics, Inc. , United States [ www , Biotechnology , - ] 39: Study of BioAegis’ Lead Product, Gelsolin, is Key Component of NIAID Strategic Plan for COVID-19 Research - BioAegis Therapeutics Inc. announces that the National Institute of Health (NIH) Clinical Center is measuring patient gelsolin levels as part of the NIAID Strategic Plan for COVID-19 Research. BioAegis’ lead product, recombinant human plasma gelsolin (rhu-pGSN), is based on this highly abundant circulating human protein. This study is a critical step in a large international collaborative to understand the immune response during COVID-19 infection and convalescence. More... (May 21, 2020) [Research/Studies/Reports/Recognitions]

Brigham And Women's Hospital , United States [ www ] 40: Large International Study of Chloroquine for COVID-19 Shows No Benefit and Significant Harm - Researchers at Brigham and Women's Hospital in Boston and international colleagues published the results of a study of 96,032 hospitalized COVID-19 patients, evaluating whether the use of antimalarial drugs chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, were helpful in battling the disease. They found that of the 15,000 patients who received either of the drugs were almost twice as likely to die compared to the patients who did not receive them. More... (May 22, 2020) [Treatment Initiatives]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Chan Soon-Shiong Institute of Molecular Medicine , United States [ www , Research Institute ] 41: Windber institute launches COVID-19 antibody research project - Scientists at Windber’s renowned research institute are gaining inspiration from the organization’s earliest days to address today’s COVID-19 pandemic while looking to the future. Researchers at Chan Soon-Shiong Institute of Molecular Medicine are working with Chan Soon-Shiong Medical Center at Windber’s new COVID-19 antibody testing program to explore new studies of the virus that causes the disease. More... (May 20,

2020) [Research/Studies/Reports/Recognitions]

Cleveland Clinic Florida , United States [ www ] 42: Vitamin C, Zinc to be studied as COVID-19 treatment - Cleveland Clinic Florida is about to begin what they hope will be promising research in the race to find more treatments to make COVID-19 a threat of the past. Researchers will be testing whether Vitamin C and Zinc help reduce the likelihood of a newly diagnosed COVID-19 patient being hospitalized. Researchers also want to see if it can reduce the severity and duration of symptoms. More... (May 22, 2020) [Research/Studies/Reports/Recognitions]

Columbus Regional Research Institute, LLC , United States 43: COVID-19 clinical trial testing underway in Columbus - The Columbus Regional Research Institute is conducting the outpatient trials for people who have tested positive for COVID-19. The single visit studies require a single blood draw and nasal swab. The institute is hoping to get about 300 participants. Those who qualify will receive a $50 gift card. The goal is to learn more about how immunities are formed in the body and at what point patients are no longer contagious. More... (May 18,

2020) [Treatment Initiatives]

Emory University , United States [ www , Academic Institution ] 44: Emory research points to success of neutralizing antibodies in the COVID-19 fight - Emory University has made strides in this sector recently, with new studies showing that nearly all people hospitalized with COVID-19 ended up developing neutralizing antibodies, capable of fighting the virus, within six days of testing positive. These findings are expected to help the medical community better understand immunity and inform a clearer path to vaccine development. More... (May 20, 2020) [Research/Studies/Reports/Recognitions]

Fitbit Inc , United States [ www , FIT , Medical Devices , LargeCap ] 45: Fitbit launches COVID-19 wearables study for early detection algorithm - Fitbit has launched an in-app study the company says could help develop an algorithm for detecting potential COVID-19 cases prior to symptom onset. Device owners over the age of 21 who live in the U.S. or Canada who either had a confirmed case of COVID-19 or recently experienced symptoms consistent with the disease are invited to take part in what the company has dubbed the Fitbit COVID-19 study. More... (May 22, 2020) [Research/Studies/Reports/Recognitions]

Icahn School of Medicine at Mount Sinai , United States [ www , Academic Institution ] 46: New study sheds light on IBD patients with COVID - In an upcoming study to be published in Gastroenterology, researchers at the Icahn School of Medicine at Mount Sinai and the University of North Carolina School of Medicine report on the clinical course of COVID-19 and risk factors for adverse outcomes in a large cohort of patients with IBD collected through an international registry. More... (May

18, 2020) [Research/Studies/Reports/Recognitions]

Innovative Trials Ltd , United Kingdom [ www , Healthcare Services , - ] 47: Clinical trials company calls for unity and action to address lack of patient diversity in research - Innovative Trials, a clinical trial patient recruitment company, is calling on the medical research community and pharmaceutical sector to come together to tackle the issue of patient diversity in research, particularly in light of the Covid-19 outbreak. The company is concerned that the fast pace

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

of Covid-19 research to find treatments and vaccines, combined with long-held, industry-wide challenges of recruiting people from black, Asian and minority ethnic (BAME) communities into clinical trials, means these groups could be ‘missed out’ from research. More... (May 20, 2020) [Research/Studies/Reports/Recognitions]

iSpecimen, Inc. , United States [ www , Biotechnology , - ] 48: iSpecimen® and myOnsite HealthCare deploy mobile phlebotomy to help advance research during the coronavirus pandemic - iSpecimen announced a new initiative in the battle against COVID-19 and other diseases – mobile phlebotomy support that will bring convenient, at-home sample collection to patients and donors interested in advancing research who would otherwise have limited ability to participate. In the case of COVID-19 collections, direct-to-donor services help expand access to samples from post-symptomatic patients, which will help advance the development of treatments, therapies, and potentially a vaccine. More... (May 20, 2020) [Research/Studies/Reports/Recognitions]

Lawrence Livermore National Laboratory , United States [ www , Research Institute ] 49: LLNL providing critical assistance in addressing national swab shortage for COVID-19 testing - Lawrence Livermore National Laboratory engineers formed an ad hoc, rapid response team that has tested more than a dozen novel, 3D-printed nasal swab designs (hundreds of individual swabs) from a grassroots coalition of commercial and academic partners. The mechanical tests performed at the Lab, simulating how the swabs might be used in a clinical environment, provided valuable feedback that improved the designs, enabling them to meet requirements for COVID-19 testing. More... (May 20, 2020) [Treatment Initiatives]

50: LLNL makes COVID-19 research public through new searchable data portal - To help accelerate discovery of therapeutic antibodies or antiviral drugs for SARS-CoV-2, the virus that causes COVID-19, Lawrence Livermore National Laboratory has launched a searchable data portal to share its COVID-19 research with scientists worldwide and the general public. More... (May 19, 2020) [Research/Studies/Reports/Recognitions]

Nanome, Inc , United States [ www , Software , - ] 51: Scientists Use Virtual Reality to Refine New AI-Generated Drugs for COVID-19 - Nanome, Inc., a virtual reality (VR) startup whose signature product is a computational chemistry software platform, has co-authored a paper describing 10 potential small molecule inhibitors targeting the SARS-CoV-2 main protease that were generated by artificial intelligence (AI). The study was conducted in collaboration with Insilico Medicine, an artificial intelligence company based in Hong Kong, and could reveal as-of-yet-undiscovered methods for attacking the virus that have eluded scientists working with existing drug candidates. More... (May 21, 2020) [Research/Studies/Reports/Recognitions]

National Natural Science Foundation of China , China [ www , Organization ] 52: The Dynamic Changes of Antibodies against SARS-CoV-2 during the Infection and Recovery of COVID-19 - Deciphering the dynamic changes of antibodies against SARS-CoV-2 is essential for understanding the immune response in COVID-19 patients. By comprehensively analyzing the laboratory findings of 1,850 patients, we describe the dynamic changes of the total antibody, spike protein (S)-, receptor-binding domain (RBD)-, and nucleoprotein (N)- specific IgM and IgG levels during SARS-CoV-2 infection and recovery. More... (May 18, 2020) [Research/Studies/Reports/Recognitions]

Oxford Immunotec Global PLC , United Kingdom [ OXFD , Biotechnology , SmallCap ] 53: Oxford Immunotec releases the T-SPOT® Discovery™ SARS-CoV-2 kit for research into measuring the T cell immune response to SARS-CoV-2, which may offer new insights into immunity to COVID-19 - Oxford Immunotec Global PLC , a global, high-growth diagnostics company announces the release of the T-SPOT Discovery SARS-CoV-2 test kit. This kit is for research use only

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

and launched under the T-SPOT Discovery brand. This research kit could make a significant contribution towards development of a new tool to manage the COVID-19 pandemic, which in turn could help to bring nations out of their current lockdowns in a faster, safer and more controlled manner. More... (May 19,

2020) [Treatment Initiatives]

University of Bristol , United Kingdom [ www , Academic Institution ] 54: Observational Study Aims To Identify Biomarkers That Could Predict COVID-19 Outcome - A new observational study aimed at identifying markers that predict how COVID-19 affects patients is being led by clinicians and academics at North Bristol NHS Trust and the University of Bristol. The DISCOVER (DIagnostic and Severity markers of COVID-19 to Enable Rapid triage) study is focused on blood-based biomarkers and their ability to predict a patient’s disease course alongside demographic factors such as age, sex, frailty and other medical conditions. More... (May 19, 2020) [Research/Studies/Reports/Recognitions]

University of California, Berkeley , United States [ www , Academic Institution ] 55: UC Berkeley: Scientists Pivot To Coronavirus Research, Hoping For Quick Results To Deal With Pandemic - Seven COVID-19 research projects at the University of California, Berkeley, are getting an infusion of cash — $2.2 million in all — that could turn up new diagnostics and potential treatments for the infection within months. More... (May 19, 2020) [Research/Studies/Reports/Recognitions]

University of Glasgow , United Kingdom [ www , Academic Institution ] 56: Glasgow heart scientists fast-track coronavirus research - A number of projects under the Scottish Government’s Rapid Research programme are underway, including two involving scientists from our Glasgow Centre for Research Excellence. Our funded researchers at the University of Glasgow are supporting global efforts to combat Covid-19 and better understand its wider effects on people with heart and circulatory diseases. More... (May 20, 2020) [Research/Studies/Reports/Recognitions]

University of Notre Dame , United States [ www , Academic Institution ] 57: Researchers work to quantify the human immune response to COVID-19 - Across the country, public health officials have begun administering antibody tests aimed at identifying Americans who may have been exposed to the novel coronavirus and have potentially developed immunity to the disease. But even with testing underway, experts say there are more questions than answers around the results. More... (May 18, 2020) [Research/Studies/Reports/Recognitions]

University of Southern California , United States [ www , Academic Institution ] 58: USC Study Finds Even Greater Coronavirus Antibody Prevalence In LA Than Santa Clara Study - A study that tested 863 Los Angeles County residents last month found that 4 percent of them carried antibodies for SARS-CoV-2 — and 60 percent of those who had been exposed to the virus were entirely asymptomatic. The study was conducted by researchers at USC, and it followed on a similar antibody prevalence study conducted in Santa Clara County in early April. More... (May 20, 2020) [Research/Studies/Reports/Recognitions]

Verily Life Sciences LLC , United States [ www , Biotechnology , - ] 59: Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project - Verily has launched a new clinical research effort focused on COVID-19 antibody testing and exploring the body’s immune response to the novel coronavirus. Conducted under its Project Baseline endeavors, the life science-focused Google sibling said people who participate in the new studies could potentially help test new public health tools or future interventions. More... (May 18, 2020) [Research/Studies/Reports/Recognitions]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Vitalant Research Institute , United States [ www , Research Institute ] 60: CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas - The U.S. Centers for Disease Control and Prevention (CDC) plans a nationwide study of up to 325,000 people to track how the new coronavirus is spreading across the country into next year and beyond. The CDC study, expected to launch in June or July, will test samples from blood donors in 25 metropolitan areas for antibodies created when the immune system fights the coronavirus, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute. More... (May 19, 2020) [Research/Studies/Reports/Recognitions]

Back

Grants/ Investment/ Funding/ Donations

4Basebio AG , Germany [ www , 4BSB , Biotechnology , SmallCap ] 61: Simple and rapid SARS-CoV-2 diagnostic test project with 4basebio's contribution receives funding from 'la Caixa' Banking Foundation - 4basebio AG announced that the research consortium for the development of a new corona virus diagnosis approach led by Dr. Felipe Cortés (Spanish National Cancer Research Center) and Dr. Luis Blanco ("Severo Ochoa" Molecular Biology Center) has been granted the maximum amount of € 299,200 of funding from the "la Caixa" Banking Foundation CaixaImpulse. More... (May 20, 2020) [Debt/Loans/Notes/Bonds/Credit Facility Updates]

International Vaccine Institute , South Korea [ www , Organization ] 62: IVI to strengthen COVID-19 surveillance in sub-Saharan Africa with support from Sweden - The International Vaccine Institute (IVI) announced that the Swedish International Development Cooperation Agency (Sida) has contributed an additional 6,200,000 SEK (approx. 630,000 USD) to IVI to support national responses to COVID-19 in Madagascar and Burkina Faso. Detecting cases of COVID-19 requires trained personnel, equipment, and centralized infrastructure to carry out screening and diagnostic testing which may be limited in low-income countries. More... (May 21, 2020) [Debt/Loans/Notes/Bonds/Credit Facility Updates]

Ondine Biomedical Inc , Canada [ www , Biotechnology , - ] 63: Ondine Biomedical Accelerates COVID-19 Program - Ondine Biomedical Inc. announces that it has secured funding from investors including TELUS Ventures to bring the benefits of its Photodisinfection technology to the COVID-19 battle. The company is focusing its efforts to help protect healthcare professionals, essential workers, and at-risk carriers of SARS-CoV-2 from development of COVID-19 symptoms, as well as life-threatening secondary infections resulting from other nasal pathogens. More... (May 21, 2020) [Debt/Loans/Notes/Bonds/Credit Facility Updates]

Open Orphan PLC , United Kingdom [ www , ORPH , Pharmaceuticals , LargeCap ] 64: Open Orphan launches £12m equity raising to fund Covid-19 tests, models - Pharmaceutical services company Open Orphan launched a £12m share issue to fund the development Covid-19 antibody tests and vaccine study models for the disease. More... (May 22, 2020) [Debt/Loans/Notes/Bonds/Credit Facility Updates]

Sherlock Biosciences Inc , United States [ www , Biotechnology , - ] 65: Sherlock Biosciences Launches Innovation Lab to Develop COVID-19 Diagnostics with $7.5 Million Grant from Open Philanthropy - Sherlock Biosciences, an Engineering Biology company dedicated to making diagnostic testing better, faster and more affordable announced that Open Philanthropy is advancing $7.5 million in grant funding to launch the Sherlock Innovation Lab and accelerate the development of Sherlock’s at-home COVID-19 diagnostic utilizing its INSPECTR™ platform. More... (May 21, 2020) [Debt/Loans/Notes/Bonds/Credit Facility Updates]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Back

Manufacturing Facility/ Production Related

Aran Biomedical Teoranta , Ireland [ www , Biotechnology , - ] 66: Aran Biomedical to Make ProTEX Med® Implantable Grade Polypropylene Resin Available to Support Pharmaceutical Companies Combatting COVID 19 - Aran Biomedical has announced the availability of its ProTEX Med® implantable grade material for purchase as a standalone raw material for products requiring implant grade polypropylene (PP).The decision was announced to accommodate the increasing number of enquiries for implantable grade polypropylene for pharmaceutical and blood testing purposes. The material was previously offered exclusively for companies leveraging Aran Biomedical’s implantable textile manufacturing services, but the company now sees enquiries for implantable grade polypropylene for much broader indications. More... (May 21, 2020) [Treatment Initiatives]

Bio-Techne Corp , United States [ www , TECH , Biotechnology , MidCap ] 67: Bio-Techne And Kantaro Biosciences Announce Partnership To Develop And Scale Production Of Covid-19 Serology Test - Bio-Techne Corporation and the Mount Sinai Health System in New York, through its commercial affiliate Kantaro Biosciences LLC (Kantaro) announced a partnership to initiate scaled manufacturing and distribution of testing kits based on the Mount Sinai-developed COVID-19 serology test. More... (May 19, 2020) [Collaborations]

Curative Inc. , United States [ www , Biotechnology , - ] 68: COVID-19 Testing Provider Curative Acquires KorvaLabs - COVID-19 testing startup Curative Inc. announced that it has completed the acquisition of KorvaLabs, Inc., a CLIA certified and DEA licensed analytical laboratory based in San Dimas, California. The acquisition arrives just months after the two organizations first partnered to begin manufacturing and processing Curative’s oral fluid-based COVID-19 test. More... (May 19, 2020) [Acquisitions/Mergers]

Europlaz Technologies Ltd , United Kingdom [ www , Medical Devices , - ] 69: Europlaz Technologies Ltd secures contract to manufacture COVID-19 Test Kits - New antibody test kits for ongoing COVID-19 testing and immunity research are now being manufactured in Essex. Europlaz Technologies Ltd, based in Southminster in Essex, have signed a contract to exclusively manufacture a COVID-19 antibody test kits. While the existing COVID-19 swab test currently being used by the Government and health services can detect whether a person has the virus at that moment, it cannot tell whether a person has had the virus previously and since recovered. These swab tests also take some time to generate a result. More... (May 20, 2020) [Collaborations]

Mount Sinai Health System , United States [ www ] 70: Mount Sinai Health System and Renalytix Form Joint Venture, Kantaro Biosciences, To Develop and Scale Production of COVID Antibody Test Kits - Mount Sinai Health System and Renalytix AI announced the formation of Kantaro Biosciences, LLC , a Mount Sinai venture, to develop and scale production and distribution of a test kit based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies. More... (May 19, 2020) [Collaborations]

Thermo Fisher Scientific Inc. , United States [ www , TMO , Medical Devices , MidCap ] 71: Thermo Fisher Scientific inks COVID-19 test tube deal with U.S. government - The U.S. government is rapidly scaling its quotas for COVID-19 testing and relying on drugmakers and manufacturers to step up to the challenge. Now, CDMO Thermo Fisher Scientific has scored a U.S. contract to help produce a key tool for the ramped-up testing. More... (May 19, 2020) [Collaborations]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Zydus Cadila , India [ www , 532321 , Pharmaceuticals , LargeCap ] 72: Zydus delivers first batch of antibody test kits to ICMR - The first batch of 30,000 COVID KAVACH ELISA Tests manufactured by Zydus Diagnostics, has been supplied to Indian Council of Medical Research (ICMR), free of cost. These test kits have been manufactured in technology transfer with ICMR-NIV of Pune for surveillance purposes. More... (May 22, 2020) [Social Support]

Back

Molecular Diagnostics

Advanced Biological Laboratories S.A. , Luxembourg [ www , Medical Devices , - ] 73: Advanced Biological Laboratories receives Ce-Ivd registration for its Ultragene Combo2Screen Sars-Cov-2 Assay - Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene® Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen. The real-time RT-PCR test aids the diagnosis of coronavirus disease (Covid-19) infection. More... (May 21, 2020) [Research/Studies/Reports/Recognitions]

Gold Standard Diagnostics, Inc , United States [ www , Biotechnology , - ] 74: Gold Standard Diagnostics Multiplex Real-Time PCR Assay for SARS-CoV-2 Pathogen Detection Now Available in the US - Gold Standard Diagnostics Inc. announced the EUA submission of a Multiplex Real-Time, reverse-transcriptase polymerase chain reaction (RT-PCR) assay for the direct qualitative pathogen detection of the novel coronavirus (SARS-CoV-2). The assay is available now for purchase in the U.S. Particularly in the early phase of COVID-19 infection, the direct and precise diagnostic of the pathogen is critical. More... (May 18, 2020) [Treatment Initiatives]

Nimble Therapeutics Inc , United States [ www , Biotechnology , - ] 75: Nimble Therapeutics working on diagnostics of virus that causes Covid-19 - Madison-based Nimble Therapeutics, a startup that was spun out from Switzerland-based F. Hoffmann-La Roche, is collaborating with global biotech company Roche Diagnostics to discover and develop novel peptide-based molecules for diagnostics of SARS-CoV-2, the virus that causes Covid-19. More... (May 21, 2020) [Collaborations]

Back

Regulatory Authorization/Approval

Best Chance Products, LLC , United States [ www , Pharmaceuticals , - ] 76: Best Chance Products, LLC Named Exclusive Distributor For BioCore Co., Ltd.'s COVID-19 PCR Test - California based Best Chance Products, LLC announced that BioCore Co., Ltd., a South Korean manufacturer of 2019 nCoV Real Time PCR Test Kits, has named it the exclusive distributor of BioCore's COVID-19 Tests in the United States. BioCare received Emergency Use Authorization ("EUA") from the US Food and Drug Administration to sell its COVID-19 tests in the United States. More... (May 22, 2020) [Collaborations]

BioMerieux SA , France [ www , BIM , Biotechnology , LargeCap ] 77: CE marking of bioMérieux serology tests for SARS-CoV-2 on VIDAS® - BioMérieux, a world leader in the field of in vitro diagnostics announced the CE marking of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to SARS-CoV-2 which causes the COVID-19 disease. More... (May 21, 2020) [Treatment Initiatives]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Enzo Biochem, Inc. , United States [ www , ENZ , Commercial Services , LargeCap ] 78: Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV- 2 IgG Antibody Under FDA’s Emergency Use Authorization - Enzo Biochem, Inc. a leading biosciences and diagnostics company, announced that it is currently offering a SARS-CoV-2 IgG ELISA assay kit for serological detection of IgG antibodies against the novel coronavirus under the FDA’s Emergency Use Authorization authority as both products and services. While molecular tests detect the presence of viral RNA to diagnose active infection, serological tests are used to detect the presence of antibodies to the SARSCoV- 2 virus. More... (May 20, 2020) [Treatment Initiatives]

Everly Well, Inc. , United States [ www , Healthcare Services , - ] 79: Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind - Everlywell, the digital health company which offers individuals access to at-home collection lab tests for cholesterol, diabetes, STIs, hormones, and more, announced that the company has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 at-home collection kit. More... (May 18, 2020) [Treatment Initiatives]

Fulgent Genetics Inc , United States [ www , FLGT , Biotechnology , SmallCap ] 80: Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus that Causes COVID-19 - Fulgent Genetics, Inc, a provider of comprehensive genetic testing solutions announced that its subsidiary, Fulgent Therapeutics, LLC, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its RT-PCR test for the detection of SARS-CoV-2, the virus that causes COVID-19, using upper respiratory specimens (nasal, nasopharyngeal, and oropharyngeal swabs). More... (May 18, 2020) [Treatment

Initiatives]

Genedrive plc , United Kingdom [ www , GDR , Medical Devices , SmallCap ] 81: Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark - Genedrive plc , the near patient molecular diagnostics company, announces that the Genedrive® 96 SARSCoV-2 Kit is now CE-IVD marked and is available for commercial sale across the European Union, including the UK, whilst also accelerating market access to countries that accept the CE-IVD mark. More... (May 22, 2020) [Treatment

Initiatives]

HiberGene Diagnostics , Ireland [ www , Healthcare Services , - ] 82: HiberGene Diagnostics announces CE marking of COVID-19 test - HiberGene Diagnostics is pleased to announce that it has successfully completed the CE marking of a new rapid molecular COVID-19 test, which is now available for sale in Ireland and internationally. More... (May 20, 2020) [Treatment Initiatives]

Macrogen Inc , South Korea [ www , 038290 , Biotechnology , LargeCap ] 83: Macrogen obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' - The Korean biotech company Macrogen, announced that it obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' from the Ministry of Food and Drug Safety (MFDS). More... (May 21, 2020) [Treatment Initiatives]

Medmira Inc , Canada [ www , MIR , Medical Devices , SmallCap ] 84: MedMira Announces Progress Update of its REVEALCOVID-19™ Total Antibody Test Including CE Mark - MedMira Inc announced that it has completed the registration process and affixed the CE mark (Conformité Européene) to its rapid REVEALCOVID-19™ Total Antibody Test. More... (May

21, 2020) [Treatment Initiatives]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

OraSure Technologies, Inc. , United States [ www , OSUR , Medical Devices , LargeCap ] 85: OraSure’s OMNIgene®·ORAL Kit Included in EUA Granted to P23 Labs for At-Home Collection of Saliva Samples for SARS-CoV-2 Test - OraSure Technologies, Inc, a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, announced that its OMNIgene®·ORAL saliva collection device (OM-505) was included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to P23 Labs. This EUA permits individuals to self-collect saliva specimens at-home for the detection of SARS-CoV-2. More... (May 22, 2020) [Treatment Initiatives]

Quidel Corporation , United States [ www , QDEL , Pharmaceuticals , MidCap ] 86: Quidel’S Lyra® Direct Sars-Cov-2 Assay Receives Emergency Use Authorization And Ce Mark For Molecular Detection Of Covid-19, Without Extraction Step - Quidel Corporation ,a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that Quidel has received Emergency Use Authorization (EUA) for the Lyra® Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing. More... (May 18, 2020) [Treatment Initiatives]

SLS BIO Co., Ltd , South Korea [ www , Pharmaceuticals , - ] 87: SLS Bio scores nod for exporting Covid-19 test kits - SLS Bio has won approval from the Ministry of Food and Drug Safety to export its Covid-19 antibody test kit. The company will also apply for licenses for its SsmarTest Covid-19 IgG/IgM detection to foreign regulators, including Conformite Europeen (CE) mark and U.S. Food and Drug Administration. The company is to enter global markets and commercialize its product as early as possible. More... (May 22, 2020) [Imports/Exports]

SunBeam Laboratories LLC , United States [ www , Pharmaceuticals , - ] 88: Homeland Security Seizes Large Amount Of Mislabeled COVID-19 Test Kits and PPI Supplies - More than 22,000 non-FDA approved KN-95 masks and 1,000 non-FDA approved COVID-19 test kits from Sunbeam Labs were seized by Homeland Security Buffalo agents. The test kits and face masks were mislabeled and seized for wire fraud and in violation of the Federal Food, Drug, and Cosmetic Act. More... (May 23, 2020) [Treatment Initiatives]

TBG Diagnostics Ltd , Australia [ www , TDLAF , Biotechnology , SmallCap ] 89: TBG Biotechnology Corp. confirms CR Mark Approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kit - TBG Diagnostics Limited is pleased to announce that its wholly owned subsidiary TBG Biotechnology Corp. has received the CE Mark approval for its ExProbeTM SARS-CoV-2 Testing Kit and SARS-CoV-2 IgG / IgM Rapid Test Kit. More... (May 21, 2020) [Treatment Initiatives]

Back

Technology Updates

Behold.ai Technologies Limited , United Kingdom [ www , Medical Devices , - ] 90: Behold.ai partners with Apollo Hospitals Group, India for rapid COVID-19 diagnosis using AI-based chest X-ray technology - Behold.ai, the UK Artificial Intelligence radiology company announced its partnership with Apollo Radiology International, part of the Apollo Hospitals Group and a leading provider of interpretative and other clinical radiological services, on a pilot programme using Behold.ai’s ‘instant triage’ AI-based chest X-ray technology to quickly triage suspected COVID-19 patients. More... (May 18, 2020) [Collaborations]

G42 Healthcare , United Arab Emirates [ www , Healthcare Services , - ] 91: G42 Healthcare Launches Health AI Services to Accelerate COVID-19 Diagnosis and Drug

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Discovery - A new tool is now available to the world to fight against COVID-19. G42 Healthcare, a Group 42 (G42) company, announced the launch of its G42 Health AI Platform. The AI-powered, cloud-based solution, provides researchers, medical organizations and scientific institutes across the world with advanced tools to speed up the detection of COVID-19 in potentially infected patients as well as accelerate the discovery of a conclusive drug used for its treatment. More... (May 19, 2020) [Technology

Updates]

Indica Labs Inc , United States [ www , Biotechnology , - ] 92: Indica Labs, Octo, and Axle Work with NIH to Launch a Global COVID-19 Digital Pathology Repository - Indica Labs, a leading provider of computational pathology software, and Octo, a premier information technology systems provider to the U.S. Federal Government, are pleased to announce the online COVID Digital Pathology Repository (COVID-DPR), a virtual collection of high resolution microscopic COVID-related human tissue images hosted at the National Institutes of Health. More... (May 21, 2020) [Treatment Initiatives]

International Holdings Company PJSC , United Arab Emirates [ www , Diversified Financial Services , - ] 93: UAE develops laser-based technology for faster, mass-scale coronavirus screening - QuantLase Imaging Lab, the medical-research arm of the Abu Dhabi Stock Exchange-listed International Holdings Company (IHC), announced that it has developed novel equipment which enables for much faster mass screenings, with test results available in seconds and allowing testing on a wider scale. This break-through will enable ‘Mass-scale screening’, changing the whole dimension of tracing. More... (May

22, 2020) [Research/Studies/Reports/Recognitions]

Mount Sinai Health System , United States [ www ] 94: Mount Sinai First in U.S. to Use Artificial Intelligence to Analyze Coronavirus (COVID-19) Patients - Mount Sinai researchers are the first in the country to use artificial intelligence (AI) combined with imaging, and clinical data to analyze patients with coronavirus disease (COVID-19). They have developed a unique algorithm that can rapidly detect COVID-19 based on how lung disease looks in computed tomography (CT scans) of the chest, in combination with patient information including symptoms, age, bloodwork, and possible contact with someone infected with the virus. More... (May 19,

2020) [Treatment Initiatives]

Nephron Pharmaceuticals Corporation , United States [ www , Pharmaceuticals , - ] 95: Nephron, One Medical Partner To Offer Covid-19 Testing Services - Nephron Pharmaceuticals Corporation, one of the fastest growing pharmaceutical companies in the country announced a new partnership with One Medical, a leading national digital health and primary care organization that combines 24/7 access to virtual care and digital health tools with COVID-19 testing services to businesses and employees. More... (May 21, 2020) [Collaborations]

Philips North America LLC , United States [ www , Electronics , - ] 96: Philips Ultrasounds Cleared in U.S. to Manage COVID Complications - The FDA has granted Philips 510(k) clearance for its ultrasound systems to be used to address lung and cardiac complications that arise in COVID-19 patients. The clearance encompasses the firm’s EPIQ series, Affiniti series, Lumify, CX50 and Sparq diagnostic ultrasounds, and for offerings such as the QLAB Advanced Quantification Software. Ultrasounds can help to diagnose patients with signs of respiratory distress and portable ultrasounds, such as the Philips Lumify, can do so at the point of care. More... (May 19, 2020) [Treatment Initiatives]

Sunquest Information Systems Inc. , United States [ www , Healthcare Services , - ] 97: Sunquest WorldCare™ Disease Surveillance, Outbreak, and Management Solution Enables

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Rapid Response to COVID-19 - Sunquest Information Systems, Inc. announced the availability of its Sunquest WorldCare™ disease surveillance and outbreak management solution to support public health organizations looking to track and respond to COVID-19. Developed for public health departments to track a broad range of conditions, Sunquest WorldCare uses data from laboratories and health practitioners to aid in the investigation of communicable or chronic disease incidents for improved reporting, intervention and management. More... (May 21, 2020) [Treatment Initiatives]

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Top

Appendix 1: COVID-19 Diagnostics/Devices Advances News List: By Region

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

Africa/Middle East

Israel Todos Medical Ltd ( www , TOMDF , Biotechnology , SmallCap )

Todos Medical Announces First Commercial Sale of COVID-19 Antibody Tests (May 18, 2020) Sec1-12

United Arab Emirates

G42 Healthcare ( www , Healthcare Services )

G42 Healthcare Launches Health AI Services to Accelerate COVID-19 Diagnosis and Drug Discovery (May 19, 2020) Sec1-91

United Arab Emirates

International Holdings Company PJSC ( www , Diversified Financial Services )

UAE develops laser-based technology for faster, mass-scale coronavirus screening (May 22, 2020) Sec1-93

Americas

Canada Medmira Inc ( www , MIR , Medical Devices , SmallCap )

MedMira Announces Progress Update of its REVEALCOVID-19™ Total Antibody Test Including CE Mark (May 21, 2020) Sec1-84

Canada Ondine Biomedical Inc ( www , Biotechnology ) Ondine Biomedical Accelerates COVID-19 Program (May 21, 2020) Sec1-63

Canada Promis Neurosciences Inc ( www , PMN , Biotechnology , SmallCap )

ProMIS Neurosciences and BC Neuroimmunology expand collaboration to develop and commercialize proprietary diagnostic assay (May 19, 2020) Sec1-20

United States 23andMe, Inc ( www , Biotechnology ) 23 and Me expands COVID-19 genetics study (May 21, 2020) Sec1-34

United States Abbott Laboratories ( www , ABT , Healthcare Services , LargeCap )

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests (May 22, 2020) Sec1-1

United States Abbott Laboratories ( www , ABT , Healthcare Services , LargeCap )

Abbott Releases Interim Clinical Study Data On Id Now Covid-19 Rapid Test Showing Strong Agreement To Lab-Based Molecular Pcr Tests (May 21, 2020)

Sec1-35

United States Aegea Biotechnologies, Inc. ( www , Biotechnology )

Aegea Biotechnologies, Inc. Announces The Issuance Of 7 Additional Key U.S. Patents Relating To Its Core, Next Generation Nucleic Acid Clinical Diagnostic Technologies And Covid-19 Test Development (May 18, 2020)

Sec1-13

United States Aetion, Inc. ( www , Software ) Aetion and FDA Team Up for RWE Study to Advance Understanding of COVID-19 (May 19, 2020) Sec1-36

United States Aldeyra Therapeutics Inc ( www , ALDX , Biotechnology , LargeCap )

Aldeyra Therapeutics to Advance ADX-1612, an Investigational New HSP90 Inhibitor with Potential Nanomolar Potency Against SARS-CoV-2, to Clinical Testing for COVID-19; ADX-629 Accepted for BARDA CoronaWatch Meeting (May 20, 2020)

Sec1-14

United States Babson Diagnostics, Inc ( www , Healthcare Services )

Babson Diagnostics Enters Collaborative Research Agreement with Dell Medical School to Study Immune Response to COVID-19 (May 20, 2020) Sec1-38

United States Best Chance Products, LLC ( www , Pharmaceuticals )

Best Chance Products, LLC Named Exclusive Distributor For BioCore Co., Ltd.'s COVID-19 PCR Test (May 22, 2020) Sec1-76

United States BioAegis Therapeutics, Inc. ( www , Biotechnology )

Study of BioAegis’ Lead Product, Gelsolin, is Key Component of NIAID Strategic Plan for COVID-19 Research (May 21, 2020) Sec1-39

United States Biodesix, Inc ( www , Biotechnology )

Biodesix Partners with Bio-Rad to Launch a Serology Test to Detect Coronavirus (COVID-19) Antibodies (May 19, 2020) Sec1-3

United States Bio-Techne Corp ( www , TECH , Biotechnology , MidCap )

Bio-Techne And Kantaro Biosciences Announce Partnership To Develop And Scale Production Of Covid-19 Serology Test (May 19, 2020) Sec1-67

United States Blanchard Valley Health System ( www , Healthcare Services )

BVHS introduces antibody testing, plasma treatment for COVID-19 (May 18, 2020) Sec1-4

United States Brigham And Women's Hospital ( www , Healthcare Services )

Large International Study of Chloroquine for COVID-19 Shows No Benefit and Significant Harm (May 22, 2020) Sec1-40

United States Bronson Health Care Group ( www , Healthcare Services )

Bronson Healthcare launches antibody testing for coronavirus (May 22, 2020) Sec1-5

United States Centers for Disease Control and Prevention (CDC) ( www ,

CDC to Launch Massive Population-based Antibody Testing for SARS-CoV-2 (May 19, 2020) Sec1-6

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no. Research Institute )

United States Chan Soon-Shiong Institute of Molecular Medicine ( www , Research Institute )

Windber institute launches COVID-19 antibody research project (May 20, 2020) Sec1-41

United States Cleveland Clinic Florida ( www , Healthcare Services )

Cleveland Clinic Akron General to Open COVID-19 Testing Site in Akron (May 19, 2020) Sec1-23

United States Cleveland Clinic Florida ( www , Healthcare Services ) Vitamin C, Zinc to be studied as COVID-19 treatment (May 22, 2020) Sec1-42

United States Columbus Regional Research Institute, LLC ( www , Research Institute )

COVID-19 clinical trial testing underway in Columbus (May 18, 2020) Sec1-43

United States Curative Inc. ( www , Biotechnology ) COVID-19 Testing Provider Curative Acquires KorvaLabs (May 19, 2020) Sec1-68

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Expands Statewide COVID-19 Response By Opening 12 Additional New Drive-Thru Test Sites in Massachusetts (May 21, 2020) Sec1-24

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Opens 14 New Drive-Thru Test Sites in California as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Opens 44 New Drive-Thru Test Sites in Texas as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States Emory University ( www , Academic Institution )

Emory research points to success of neutralizing antibodies in the COVID-19 fight (May 20, 2020) Sec1-44

United States Enzo Biochem, Inc. ( www , ENZ , Commercial Services , LargeCap )

Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV- 2 IgG Antibody Under FDA’s Emergency Use Authorization (May 20, 2020)

Sec1-78

United States Everly Well, Inc. ( www , Healthcare Services )

Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind (May 18, 2020) Sec1-79

United States Fitbit Inc ( www , FIT , Medical Devices , LargeCap )

Fitbit launches COVID-19 wearables study for early detection algorithm (May 22, 2020) Sec1-45

United States FlowMetric Diagnostics, Inc. ( www , Medical Devices )

FlowMetric Diagnostics, Inc. Announces the Expansion of Their Core Services to Include Serological Antibody Testing for SARS-CoV-2 Exposure (May 21, 2020)

Sec1-9

United States Fulgent Genetics Inc ( www , FLGT , Biotechnology , SmallCap )

Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus that Causes COVID-19 (May 18, 2020)

Sec1-80

United States Gentueri Inc ( www , Biotechnology ) Gentueri Inc. to develop COVID-19 oral testing kits (May 21, 2020) Sec1-27

United States Gold Standard Diagnostics, Inc ( www , Biotechnology )

Gold Standard Diagnostics Multiplex Real-Time PCR Assay for SARS-CoV-2 Pathogen Detection Now Available in the US (May 18, 2020) Sec1-74

United States Icahn School of Medicine at Mount Sinai ( www , Academic Institution )

New study sheds light on IBD patients with COVID (May 18, 2020) Sec1-46

United States Indica Labs Inc ( www , Biotechnology )

Indica Labs, Octo, and Axle Work with NIH to Launch a Global COVID-19 Digital Pathology Repository (May 21, 2020) Sec1-92

United States iSpecimen, Inc. ( www , Biotechnology )

iSpecimen® and myOnsite HealthCare deploy mobile phlebotomy to help advance research during the coronavirus pandemic (May 20, 2020) Sec1-48

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL providing critical assistance in addressing national swab shortage for COVID-19 testing (May 20, 2020) Sec1-49

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL makes COVID-19 research public through new searchable data portal (May 19, 2020) Sec1-

United States MagnaCare ( www , Healthcare Services )

MagnaCare and BioReference Laboratories Bring COVID-19 Antibody Testing to New York Labor Groups (May 18, 2020) Sec1-28

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai Health System and Renalytix Form Joint Venture, Kantaro Biosciences, To Develop and Scale Production of COVID Antibody Test Kits (May 19, 2020)

Sec1-70

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai First in U.S. to Use Artificial Intelligence to Analyze Coronavirus (COVID-19) Patients (May 19, 2020) Sec1-94

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

United States Nanome, Inc ( www , Software ) Scientists Use Virtual Reality to Refine New AI-Generated Drugs for COVID-19 (May 21, 2020) Sec1-51

United States Nephron Pharmaceuticals Corporation ( www , Pharmaceuticals )

Nephron, One Medical Partner To Offer Covid-19 Testing Services (May 21, 2020) Sec1-95

United States Nimble Therapeutics Inc ( www , Biotechnology )

Nimble Therapeutics working on diagnostics of virus that causes Covid-19 (May 21, 2020) Sec1-75

United States OraSure Technologies, Inc. ( www , OSUR , Medical Devices , LargeCap )

OraSure’s OMNIgene®·ORAL Kit Included in EUA Granted to P23 Labs for At-Home Collection of Saliva Samples for SARS-CoV-2 Test (May 22, 2020)

Sec1-85

United States Pathnostics ( www , Healthcare Services )

Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection (May 20, 2020) Sec1-19

United States PerkinElmer, Inc. ( www , PKI , Biotechnology , MidCap ) SARS-CoV-2 Testing From EUROIMMUN (May 18, 2020) Sec1-11

United States Philips North America LLC ( www , Electronics )

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications (May 19, 2020) Sec1-96

United States Quidel Corporation ( www , QDEL , Pharmaceuticals , MidCap )

Quidel’S Lyra® Direct Sars-Cov-2 Assay Receives Emergency Use Authorization And Ce Mark For Molecular Detection Of Covid-19, Without Extraction Step (May 18, 2020)

Sec1-86

United States Sharecare Inc ( www , Healthcare Services )

Sharecare and Augusta University forge public-private partnership to accelerate Georgia's recovery from COVID-19 (May 23, 2020) Sec1-32

United States Sherlock Biosciences Inc ( www , Biotechnology )

Sherlock Biosciences Launches Innovation Lab to Develop COVID-19 Diagnostics with $7.5 Million Grant from Open Philanthropy (May 21, 2020)

Sec1-65

United States St. Joseph Mercy Hospital ( www , Healthcare Services )

St. Joseph Mercy launches $20M COVID-19 testing and treatment centre (May 23, 2020) Sec1-33

United States SunBeam Laboratories LLC ( www , Pharmaceuticals )

Homeland Security Seizes Large Amount Of Mislabeled COVID-19 Test Kits and PPI Supplies (May 23, 2020) Sec1-88

United States Sunquest Information Systems Inc. ( www , Healthcare Services )

Sunquest WorldCare™ Disease Surveillance, Outbreak, and Management Solution Enables Rapid Response to COVID-19 (May 21, 2020) Sec1-97

United States Thermo Fisher Scientific Inc. ( www , TMO , Medical Devices , MidCap )

Thermo Fisher Scientific inks COVID-19 test tube deal with U.S. government (May 19, 2020) Sec1-71

United States University of California, Berkeley ( www , Academic Institution )

UC Berkeley: Scientists Pivot To Coronavirus Research, Hoping For Quick Results To Deal With Pandemic (May 19, 2020) Sec1-55

United States University of California, Los Angeles ( www , Academic Institution )

Team to develop Breathalyzer-like diagnostic test for COVID-19 (May 21, 2020) Sec1-21

United States University of Notre Dame ( www , Academic Institution )

Researchers work to quantify the human immune response to COVID-19 (May 18, 2020) Sec1-57

United States University of Southern California ( www , Academic Institution )

USC Study Finds Even Greater Coronavirus Antibody Prevalence In LA Than Santa Clara Study (May 20, 2020) Sec1-58

United States Verily Life Sciences LLC ( www , Biotechnology )

Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project (May 18, 2020) Sec1-59

United States Vitalant Research Institute ( www , Research Institute )

CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas (May 19, 2020) Sec1-60

Asia

Australia Genetic Technologies Limited ( www , GTG , Biotechnology , SmallCap )

Genetic Technologies - Accelerated development of new COVID-19 Polygenic Risk Test for Risk of Developing Life-Threatening Complications (May 20, 2020)

Sec1-15

Australia TBG Diagnostics Ltd ( www , TDLAF , Biotechnology , SmallCap )

TBG Biotechnology Corp. confirms CR Mark Approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kit (May 21, 2020) Sec1-89

China National Natural Science Foundation of China ( www , Organization )

The Dynamic Changes of Antibodies against SARS-CoV-2 during the Infection and Recovery of COVID-19 (May 18, 2020) Sec1-52

India Accurate Diagnostic Labs Inc. ( www , Healthcare Services )

Accurate Diagnostic Laboratories Continues to Assist Our Front-Line Workers by Offering Coronavirus Testing for Port Authority/PATH

Sec1-22

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no. Essential Employees (May 21, 2020)

India CPC Diagnostics Pvt Ltd ( www , Medical Devices )

CPC Diagnostics launches SARS COV-2 IgM, SARS COV-2 IgG tests in India (May 21, 2020) Sec1-7

India Zydus Cadila ( www , 532321 , Pharmaceuticals , LargeCap ) Zydus delivers first batch of antibody test kits to ICMR (May 22, 2020) Sec1-72

Singapore Duke-NUS Medical School ( www , Academic Institution )

New SARS-CoV-2 Test Can Detect Neutralizing Antibodies in an Hour (May 20, 2020) Sec1-8

South Korea International Vaccine Institute ( www , Organization )

IVI to strengthen COVID-19 surveillance in sub-Saharan Africa with support from Sweden (May 21, 2020) Sec1-62

South Korea Macrogen Inc ( www , 038290 , Biotechnology , LargeCap )

Macrogen obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' (May 21, 2020) Sec1-83

South Korea Seegene Inc ( www , 096530 , Medical Devices , LargeCap )

Seegene readying to bring a new test kit to address COVID-19 mutations (May 22, 2020) Sec1-31

South Korea SLS BIO Co., Ltd ( www , Pharmaceuticals ) SLS Bio scores nod for exporting Covid-19 test kits (May 22, 2020) Sec1-87

Europe

France BioMerieux SA ( www , BIM , Biotechnology , LargeCap )

CE marking of bioMérieux serology tests for SARS-CoV-2 on VIDAS® (May 21, 2020) Sec1-77

France Opencell Software ( www , Software )

OpenCell Partners with King’s College and Opentrons To Create Affordable Shipping Container COVID-19 Testing Lab (May 21, 2020) Sec1-29

Germany 4Basebio AG ( www , 4BSB , Biotechnology , SmallCap )

Simple and rapid SARS-CoV-2 diagnostic test project with 4basebio's contribution receives funding from 'la Caixa' Banking Foundation (May 20, 2020)

Sec1-61

Ireland Aran Biomedical Teoranta ( www , Biotechnology )

Aran Biomedical to Make ProTEX Med® Implantable Grade Polypropylene Resin Available to Support Pharmaceutical Companies Combatting COVID 19 (May 21, 2020)

Sec1-66

Ireland HiberGene Diagnostics ( www , Healthcare Services )

HiberGene Diagnostics announces CE marking of COVID-19 test (May 20, 2020) Sec1-82

Luxembourg Advanced Biological Laboratories S.A. ( www , Medical Devices )

Advanced Biological Laboratories receives Ce-Ivd registration for its Ultragene Combo2Screen Sars-Cov-2 Assay (May 21, 2020) Sec1-73

Spain IberoGEN ( www , Biotechnology )

IberoGEN develops kit to detect coronavirus on surfaces susceptible to contamination (May 22, 2020) Sec1-17

Switzerland Roche Holding AG ( www , RO , Pharmaceuticals , LargeCap )

Roche highly accurate antibody test for COVID-19 goes live at more than 20 initial lab sites in the US (May 19, 2020) Sec1-30

United Kingdom Aladdin Healthcare Technologies SE ( www , Healthcare Services )

Aladdin Healthcare Technologies SE achieves further milestone in COVID-19 drug development: Discovery of 20 new optimized compounds with AI DD platform (May 20, 2020)

Sec1-37

United Kingdom Avacta Group plc ( www , AVCT , Biotechnology , LargeCap )

Avacta and Medusa19 Enter into a Distribution Agreement for COVID-19 Antigen Test (May 20, 2020) Sec1-2

United Kingdom Behold.ai Technologies Limited ( www , Medical Devices )

Behold.ai partners with Apollo Hospitals Group, India for rapid COVID-19 diagnosis using AI-based chest X-ray technology (May 18, 2020) Sec1-90

United Kingdom Europlaz Technologies Ltd ( www , Medical Devices )

Europlaz Technologies Ltd secures contract to manufacture COVID-19 Test Kits (May 20, 2020) Sec1-69

United Kingdom Genedrive plc ( www , GDR , Medical Devices , SmallCap ) Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark (May 22, 2020) Sec1-81

United Kingdom GlaxoSmithKline plc ( www , GSK , Pharmaceuticals , LargeCap )

GSK ties up with gene editing start-up Mammoth for COVID-19 test (May 20, 2020) Sec1-16

United Kingdom Independent General Practice ( www , Healthcare Services ) IGP Launches COVID-19 Antibody Home Tests (May 22, 2020) Sec1-10

United Kingdom Innovative Trials Ltd ( www , Healthcare Services )

Clinical trials company calls for unity and action to address lack of patient diversity in research (May 20, 2020) Sec1-47

United Kingdom Open Orphan PLC ( www , ORPH , Pharmaceuticals , LargeCap )

Open Orphan launches £12m equity raising to fund Covid-19 tests, models (May 22, 2020) Sec1-64

United Kingdom Oxford Immunotec Global PLC ( www , OXFD , Biotechnology , SmallCap )

Oxford Immunotec releases the T-SPOT® Discovery™ SARS-CoV-2 kit for research into measuring the T cell immune response to SARS-CoV-2, which may offer new insights into immunity to COVID-19 (May 19, 2020)

Sec1-53

United Kingdom Oxford Nanopore Technologies Oxford Nanopore Technologies announces advanced development of Sec1-18

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no. Limited ( www , Biotechnology ) LamPORE, for rapid, highly scalable, low-cost COVID-19 detection (May

22, 2020)

United Kingdom University of Bristol ( www , Academic Institution )

Observational Study Aims To Identify Biomarkers That Could Predict COVID-19 Outcome (May 19, 2020) Sec1-54

United Kingdom University of Glasgow ( www , Academic Institution ) Glasgow heart scientists fast-track coronavirus research (May 20, 2020) Sec1-56

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Top

Appendix 2: COVID-19 Diagnostics/Devices Advances News List: By Sub-Industry

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

Biotechnology

Australia Genetic Technologies Limited ( www , GTG , SmallCap )

Genetic Technologies - Accelerated development of new COVID-19 Polygenic Risk Test for Risk of Developing Life-Threatening Complications (May 20, 2020)

Sec1-15

Australia TBG Diagnostics Ltd ( www , TDLAF , SmallCap )

TBG Biotechnology Corp. confirms CR Mark Approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kit (May 21, 2020) Sec1-89

Canada Ondine Biomedical Inc ( www ) Ondine Biomedical Accelerates COVID-19 Program (May 21, 2020) Sec1-63

Canada Promis Neurosciences Inc ( www , PMN , SmallCap )

ProMIS Neurosciences and BC Neuroimmunology expand collaboration to develop and commercialize proprietary diagnostic assay (May 19, 2020) Sec1-20

France BioMerieux SA ( www , BIM , LargeCap )

CE marking of bioMérieux serology tests for SARS-CoV-2 on VIDAS® (May 21, 2020) Sec1-77

Germany 4Basebio AG ( www , 4BSB , SmallCap )

Simple and rapid SARS-CoV-2 diagnostic test project with 4basebio's contribution receives funding from 'la Caixa' Banking Foundation (May 20, 2020)

Sec1-61

Ireland Aran Biomedical Teoranta ( www )

Aran Biomedical to Make ProTEX Med® Implantable Grade Polypropylene Resin Available to Support Pharmaceutical Companies Combatting COVID 19 (May 21, 2020)

Sec1-66

Israel Todos Medical Ltd ( www , TOMDF , SmallCap )

Todos Medical Announces First Commercial Sale of COVID-19 Antibody Tests (May 18, 2020) Sec1-12

South Korea Macrogen Inc ( www , 038290 , LargeCap )

Macrogen obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' (May 21, 2020) Sec1-83

Spain IberoGEN ( www ) IberoGEN develops kit to detect coronavirus on surfaces susceptible to contamination (May 22, 2020) Sec1-17

United Kingdom Avacta Group plc ( www , AVCT , LargeCap )

Avacta and Medusa19 Enter into a Distribution Agreement for COVID-19 Antigen Test (May 20, 2020) Sec1-2

United Kingdom Oxford Immunotec Global PLC ( www , OXFD , SmallCap )

Oxford Immunotec releases the T-SPOT® Discovery™ SARS-CoV-2 kit for research into measuring the T cell immune response to SARS-CoV-2, which may offer new insights into immunity to COVID-19 (May 19, 2020)

Sec1-53

United Kingdom Oxford Nanopore Technologies Limited ( www )

Oxford Nanopore Technologies announces advanced development of LamPORE, for rapid, highly scalable, low-cost COVID-19 detection (May 22, 2020)

Sec1-18

United States 23andMe, Inc ( www ) 23 and Me expands COVID-19 genetics study (May 21, 2020) Sec1-34

United States Aegea Biotechnologies, Inc. ( www )

Aegea Biotechnologies, Inc. Announces The Issuance Of 7 Additional Key U.S. Patents Relating To Its Core, Next Generation Nucleic Acid Clinical Diagnostic Technologies And Covid-19 Test Development (May 18, 2020)

Sec1-13

United States Aldeyra Therapeutics Inc ( www , ALDX , LargeCap )

Aldeyra Therapeutics to Advance ADX-1612, an Investigational New HSP90 Inhibitor with Potential Nanomolar Potency Against SARS-CoV-2, to Clinical Testing for COVID-19; ADX-629 Accepted for BARDA CoronaWatch Meeting (May 20, 2020)

Sec1-14

United States BioAegis Therapeutics, Inc. ( www )

Study of BioAegis’ Lead Product, Gelsolin, is Key Component of NIAID Strategic Plan for COVID-19 Research (May 21, 2020) Sec1-39

United States Biodesix, Inc ( www ) Biodesix Partners with Bio-Rad to Launch a Serology Test to Detect Coronavirus (COVID-19) Antibodies (May 19, 2020) Sec1-3

United States Bio-Techne Corp ( www , TECH , MidCap )

Bio-Techne And Kantaro Biosciences Announce Partnership To Develop And Scale Production Of Covid-19 Serology Test (May 19, 2020) Sec1-67

United States Curative Inc. ( www ) COVID-19 Testing Provider Curative Acquires KorvaLabs (May 19, 2020) Sec1-68

United States Fulgent Genetics Inc ( www , FLGT , SmallCap )

Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus that Causes COVID-19 (May 18, 2020)

Sec1-80

United States Gentueri Inc ( www ) Gentueri Inc. to develop COVID-19 oral testing kits (May 21, 2020) Sec1-27

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

United States Gold Standard Diagnostics, Inc ( www )

Gold Standard Diagnostics Multiplex Real-Time PCR Assay for SARS-CoV-2 Pathogen Detection Now Available in the US (May 18, 2020) Sec1-74

United States Indica Labs Inc ( www ) Indica Labs, Octo, and Axle Work with NIH to Launch a Global COVID-19 Digital Pathology Repository (May 21, 2020) Sec1-92

United States iSpecimen, Inc. ( www ) iSpecimen® and myOnsite HealthCare deploy mobile phlebotomy to help advance research during the coronavirus pandemic (May 20, 2020) Sec1-48

United States Nimble Therapeutics Inc ( www ) Nimble Therapeutics working on diagnostics of virus that causes Covid-19 (May 21, 2020) Sec1-75

United States PerkinElmer, Inc. ( www , PKI , MidCap ) SARS-CoV-2 Testing From EUROIMMUN (May 18, 2020) Sec1-11

United States Sherlock Biosciences Inc ( www ) Sherlock Biosciences Launches Innovation Lab to Develop COVID-19 Diagnostics with $7.5 Million Grant from Open Philanthropy (May 21, 2020) Sec1-65

United States Verily Life Sciences LLC ( www ) Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project (May 18, 2020) Sec1-59

Healthcare Services

India Accurate Diagnostic Labs Inc. ( www )

Accurate Diagnostic Laboratories Continues to Assist Our Front-Line Workers by Offering Coronavirus Testing for Port Authority/PATH Essential Employees (May 21, 2020)

Sec1-22

Ireland HiberGene Diagnostics ( www ) HiberGene Diagnostics announces CE marking of COVID-19 test (May 20, 2020) Sec1-82

United Arab Emirates G42 Healthcare ( www ) G42 Healthcare Launches Health AI Services to Accelerate COVID-19

Diagnosis and Drug Discovery (May 19, 2020) Sec1-91

United Kingdom Aladdin Healthcare Technologies SE ( www )

Aladdin Healthcare Technologies SE achieves further milestone in COVID-19 drug development: Discovery of 20 new optimized compounds with AI DD platform (May 20, 2020)

Sec1-37

United Kingdom Independent General Practice ( www ) IGP Launches COVID-19 Antibody Home Tests (May 22, 2020) Sec1-10

United Kingdom Innovative Trials Ltd ( www ) Clinical trials company calls for unity and action to address lack of patient diversity in research (May 20, 2020) Sec1-47

United States Abbott Laboratories ( www , ABT , LargeCap )

Abbott, Roche ink deals with UK for 10M coronavirus antibody tests (May 22, 2020) Sec1-1

United States Abbott Laboratories ( www , ABT , LargeCap )

Abbott Releases Interim Clinical Study Data On Id Now Covid-19 Rapid Test Showing Strong Agreement To Lab-Based Molecular Pcr Tests (May 21, 2020)

Sec1-35

United States Babson Diagnostics, Inc ( www ) Babson Diagnostics Enters Collaborative Research Agreement with Dell Medical School to Study Immune Response to COVID-19 (May 20, 2020) Sec1-38

United States Brigham And Women's Hospital ( www , Healthcare Services )

Large International Study of Chloroquine for COVID-19 Shows No Benefit and Significant Harm (May 22, 2020) Sec1-40

United States Bronson Health Care Group ( www )

Bronson Healthcare launches antibody testing for coronavirus (May 22, 2020) Sec1-5

United States Centers for Disease Control and Prevention (CDC) ( www , Research Institute )

CDC to Launch Massive Population-based Antibody Testing for SARS-CoV-2 (May 19, 2020) Sec1-6

United States Cleveland Clinic Florida ( www , Healthcare Services )

Cleveland Clinic Akron General to Open COVID-19 Testing Site in Akron (May 19, 2020) Sec1-23

United States Cleveland Clinic Florida ( www , Healthcare Services ) Vitamin C, Zinc to be studied as COVID-19 treatment (May 22, 2020) Sec1-42

United States CVS Health Corp ( www , CVS , LargeCap )

CVS Health Expands Statewide COVID-19 Response By Opening 12 Additional New Drive-Thru Test Sites in Massachusetts (May 21, 2020) Sec1-24

United States CVS Health Corp ( www , CVS , LargeCap )

CVS Health Opens 14 New Drive-Thru Test Sites in California as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States CVS Health Corp ( www , CVS , LargeCap )

CVS Health Opens 44 New Drive-Thru Test Sites in Texas as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States Everly Well, Inc. ( www ) Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind (May 18, 2020) Sec1-79

United States MagnaCare ( www ) MagnaCare and BioReference Laboratories Bring COVID-19 Antibody Testing to New York Labor Groups (May 18, 2020) Sec1-28

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Compiled by: https://vaccinewewin.com/covid-19-diagnostics-devices-news-weekly-summary/ Page 25

COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai Health System and Renalytix Form Joint Venture, Kantaro Biosciences, To Develop and Scale Production of COVID Antibody Test Kits (May 19, 2020)

Sec1-70

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai First in U.S. to Use Artificial Intelligence to Analyze Coronavirus (COVID-19) Patients (May 19, 2020) Sec1-94

United States Pathnostics ( www ) Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection (May 20, 2020) Sec1-19

United States Sharecare Inc ( www ) Sharecare and Augusta University forge public-private partnership to accelerate Georgia's recovery from COVID-19 (May 23, 2020) Sec1-32

United States St. Joseph Mercy Hospital ( www , Healthcare Services )

St. Joseph Mercy launches $20M COVID-19 testing and treatment centre (May 23, 2020) Sec1-33

United States Sunquest Information Systems Inc. ( www )

Sunquest WorldCare™ Disease Surveillance, Outbreak, and Management Solution Enables Rapid Response to COVID-19 (May 21, 2020) Sec1-97

Medical Devices

Canada Medmira Inc ( www , MIR , SmallCap )

MedMira Announces Progress Update of its REVEALCOVID-19™ Total Antibody Test Including CE Mark (May 21, 2020) Sec1-84

India CPC Diagnostics Pvt Ltd ( www ) CPC Diagnostics launches SARS COV-2 IgM, SARS COV-2 IgG tests in India (May 21, 2020) Sec1-7

Luxembourg Advanced Biological Laboratories S.A. ( www )

Advanced Biological Laboratories receives Ce-Ivd registration for its Ultragene Combo2Screen Sars-Cov-2 Assay (May 21, 2020) Sec1-73

South Korea Seegene Inc ( www , 096530 , LargeCap )

Seegene readying to bring a new test kit to address COVID-19 mutations (May 22, 2020) Sec1-31

United Kingdom Behold.ai Technologies Limited ( www )

Behold.ai partners with Apollo Hospitals Group, India for rapid COVID-19 diagnosis using AI-based chest X-ray technology (May 18, 2020) Sec1-90

United Kingdom Europlaz Technologies Ltd ( www )

Europlaz Technologies Ltd secures contract to manufacture COVID-19 Test Kits (May 20, 2020) Sec1-69

United Kingdom Genedrive plc ( www , GDR , SmallCap ) Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark (May 22, 2020) Sec1-81

United States Fitbit Inc ( www , FIT , LargeCap ) Fitbit launches COVID-19 wearables study for early detection algorithm (May 22, 2020) Sec1-45

United States FlowMetric Diagnostics, Inc. ( www )

FlowMetric Diagnostics, Inc. Announces the Expansion of Their Core Services to Include Serological Antibody Testing for SARS-CoV-2 Exposure (May 21, 2020)

Sec1-9

United States OraSure Technologies, Inc. ( www , OSUR , LargeCap )

OraSure’s OMNIgene®·ORAL Kit Included in EUA Granted to P23 Labs for At-Home Collection of Saliva Samples for SARS-CoV-2 Test (May 22, 2020)

Sec1-85

United States Thermo Fisher Scientific Inc. ( www , TMO , MidCap )

Thermo Fisher Scientific inks COVID-19 test tube deal with U.S. government (May 19, 2020) Sec1-71

Pharmaceuticals

India Zydus Cadila ( www , 532321 , LargeCap ) Zydus delivers first batch of antibody test kits to ICMR (May 22, 2020) Sec1-72

South Korea SLS BIO Co., Ltd ( www ) SLS Bio scores nod for exporting Covid-19 test kits (May 22, 2020) Sec1-87

Switzerland Roche Holding AG ( www , RO , LargeCap )

Roche highly accurate antibody test for COVID-19 goes live at more than 20 initial lab sites in the US (May 19, 2020) Sec1-30

United Kingdom GlaxoSmithKline plc ( www , GSK , LargeCap )

GSK ties up with gene editing start-up Mammoth for COVID-19 test (May 20, 2020) Sec1-16

United Kingdom Open Orphan PLC ( www , ORPH , LargeCap )

Open Orphan launches £12m equity raising to fund Covid-19 tests, models (May 22, 2020) Sec1-64

United States Best Chance Products, LLC ( www )

Best Chance Products, LLC Named Exclusive Distributor For BioCore Co., Ltd.'s COVID-19 PCR Test (May 22, 2020) Sec1-76

United States Nephron Pharmaceuticals Corporation ( www )

Nephron, One Medical Partner To Offer Covid-19 Testing Services (May 21, 2020) Sec1-95

United States Quidel Corporation ( www , QDEL , MidCap )

Quidel’S Lyra® Direct Sars-Cov-2 Assay Receives Emergency Use Authorization And Ce Mark For Molecular Detection Of Covid-19, Without Extraction Step (May 18, 2020)

Sec1-86

United States SunBeam Laboratories LLC ( www )

Homeland Security Seizes Large Amount Of Mislabeled COVID-19 Test Kits and PPI Supplies (May 23, 2020) Sec1-88

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

Academic Institutes/Research Institutes/Healthcare Organizations

China National Natural Science Foundation of China ( www , Organization )

The Dynamic Changes of Antibodies against SARS-CoV-2 during the Infection and Recovery of COVID-19 (May 18, 2020) Sec1-52

Singapore Duke-NUS Medical School ( www , Academic Institution )

New SARS-CoV-2 Test Can Detect Neutralizing Antibodies in an Hour (May 20, 2020) Sec1-8

South Korea International Vaccine Institute ( www , Organization )

IVI to strengthen COVID-19 surveillance in sub-Saharan Africa with support from Sweden (May 21, 2020) Sec1-62

United Kingdom University of Bristol ( www , Academic Institution )

Observational Study Aims To Identify Biomarkers That Could Predict COVID-19 Outcome (May 19, 2020) Sec1-54

United Kingdom University of Glasgow ( www , Academic Institution ) Glasgow heart scientists fast-track coronavirus research (May 20, 2020) Sec1-56

United States Blanchard Valley Health System ( www , Healthcare Services )

BVHS introduces antibody testing, plasma treatment for COVID-19 (May 18, 2020) Sec1-4

United States Chan Soon-Shiong Institute of Molecular Medicine ( www , Research Institute )

Windber institute launches COVID-19 antibody research project (May 20, 2020) Sec1-41

United States Columbus Regional Research Institute, LLC ( www , Research Institute )

COVID-19 clinical trial testing underway in Columbus (May 18, 2020) Sec1-43

United States Emory University ( www , Academic Institution )

Emory research points to success of neutralizing antibodies in the COVID-19 fight (May 20, 2020) Sec1-44

United States Icahn School of Medicine at Mount Sinai ( www , Academic Institution )

New study sheds light on IBD patients with COVID (May 18, 2020) Sec1-46

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL providing critical assistance in addressing national swab shortage for COVID-19 testing (May 20, 2020) Sec1-49

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL makes COVID-19 research public through new searchable data portal (May 19, 2020) Sec1-

United States University of California, Berkeley ( www , Academic Institution )

UC Berkeley: Scientists Pivot To Coronavirus Research, Hoping For Quick Results To Deal With Pandemic (May 19, 2020) Sec1-55

United States University of California, Los Angeles ( www , Academic Institution )

Team to develop Breathalyzer-like diagnostic test for COVID-19 (May 21, 2020) Sec1-21

United States University of Notre Dame ( www , Academic Institution )

Researchers work to quantify the human immune response to COVID-19 (May 18, 2020) Sec1-57

United States University of Southern California ( www , Academic Institution )

USC Study Finds Even Greater Coronavirus Antibody Prevalence In LA Than Santa Clara Study (May 20, 2020) Sec1-58

United States Vitalant Research Institute ( www , Research Institute )

CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas (May 19, 2020) Sec1-60

Other Non-Healthcare

France Opencell Software ( www , Software )

OpenCell Partners with King’s College and Opentrons To Create Affordable Shipping Container COVID-19 Testing Lab (May 21, 2020) Sec1-29

United Arab Emirates

International Holdings Company PJSC ( www , Diversified Financial Services )

UAE develops laser-based technology for faster, mass-scale coronavirus screening (May 22, 2020) Sec1-93

United States Aetion, Inc. ( www , Software ) Aetion and FDA Team Up for RWE Study to Advance Understanding of COVID-19 (May 19, 2020) Sec1-36

United States Enzo Biochem, Inc. ( www , ENZ , Commercial Services , LargeCap )

Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV- 2 IgG Antibody Under FDA’s Emergency Use Authorization (May 20, 2020)

Sec1-78

United States Nanome, Inc ( www , Software ) Scientists Use Virtual Reality to Refine New AI-Generated Drugs for COVID-19 (May 21, 2020) Sec1-51

United States Philips North America LLC ( www , Electronics )

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications (May 19, 2020) Sec1-96

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Top

Appendix 3: COVID-19 Diagnostics/Devices Advances News List from New Companies in the Fray this Week

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

Australia Genetic Technologies Limited ( www , GTG , Biotechnology , SmallCap )

Genetic Technologies - Accelerated development of new COVID-19 Polygenic Risk Test for Risk of Developing Life-Threatening Complications (May 20, 2020)

Sec1-15

Australia TBG Diagnostics Ltd ( www , TDLAF , Biotechnology , SmallCap )

TBG Biotechnology Corp. confirms CR Mark Approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kit (May 21, 2020) Sec1-89

Canada Medmira Inc ( www , MIR , Medical Devices , SmallCap )

MedMira Announces Progress Update of its REVEALCOVID-19™ Total Antibody Test Including CE Mark (May 21, 2020) Sec1-84

Canada Ondine Biomedical Inc ( www , Biotechnology ) Ondine Biomedical Accelerates COVID-19 Program (May 21, 2020) Sec1-63

Canada Promis Neurosciences Inc ( www , PMN , Biotechnology , SmallCap )

ProMIS Neurosciences and BC Neuroimmunology expand collaboration to develop and commercialize proprietary diagnostic assay (May 19, 2020)

Sec1-20

China National Natural Science Foundation of China ( www , Organization )

The Dynamic Changes of Antibodies against SARS-CoV-2 during the Infection and Recovery of COVID-19 (May 18, 2020) Sec1-52

France Opencell Software ( www , Software )

OpenCell Partners with King’s College and Opentrons To Create Affordable Shipping Container COVID-19 Testing Lab (May 21, 2020) Sec1-29

Germany 4Basebio AG ( www , 4BSB , Biotechnology , SmallCap )

Simple and rapid SARS-CoV-2 diagnostic test project with 4basebio's contribution receives funding from 'la Caixa' Banking Foundation (May 20, 2020)

Sec1-61

India Accurate Diagnostic Labs Inc. ( www , Healthcare Services )

Accurate Diagnostic Laboratories Continues to Assist Our Front-Line Workers by Offering Coronavirus Testing for Port Authority/PATH Essential Employees (May 21, 2020)

Sec1-22

India CPC Diagnostics Pvt Ltd ( www , Medical Devices )

CPC Diagnostics launches SARS COV-2 IgM, SARS COV-2 IgG tests in India (May 21, 2020) Sec1-7

India Zydus Cadila ( www , 532321 , Pharmaceuticals , LargeCap )

Zydus delivers first batch of antibody test kits to ICMR (May 22, 2020) Sec1-72

Ireland Aran Biomedical Teoranta ( www , Biotechnology )

Aran Biomedical to Make ProTEX Med® Implantable Grade Polypropylene Resin Available to Support Pharmaceutical Companies Combatting COVID 19 (May 21, 2020)

Sec1-66

Ireland HiberGene Diagnostics ( www , Healthcare Services )

HiberGene Diagnostics announces CE marking of COVID-19 test (May 20, 2020) Sec1-82

Israel Todos Medical Ltd ( www , TOMDF , Biotechnology , SmallCap )

Todos Medical Announces First Commercial Sale of COVID-19 Antibody Tests (May 18, 2020) Sec1-12

Luxembourg Advanced Biological Laboratories S.A. ( www , Medical Devices )

Advanced Biological Laboratories receives Ce-Ivd registration for its Ultragene Combo2Screen Sars-Cov-2 Assay (May 21, 2020) Sec1-73

South Korea International Vaccine Institute ( www , Organization )

IVI to strengthen COVID-19 surveillance in sub-Saharan Africa with support from Sweden (May 21, 2020) Sec1-62

South Korea Macrogen Inc ( www , 038290 , Biotechnology , LargeCap )

Macrogen obtained export approval for COVID-19 test kit 'AxenTM COVID-19 RT' (May 21, 2020) Sec1-83

South Korea Seegene Inc ( www , 096530 , Medical Devices , LargeCap )

Seegene readying to bring a new test kit to address COVID-19 mutations (May 22, 2020) Sec1-31

South Korea SLS BIO Co., Ltd ( www , Pharmaceuticals ) SLS Bio scores nod for exporting Covid-19 test kits (May 22, 2020) Sec1-87

Spain IberoGEN ( www , Biotechnology ) IberoGEN develops kit to detect coronavirus on surfaces susceptible to contamination (May 22, 2020) Sec1-17

United Arab Emirates

G42 Healthcare ( www , Healthcare Services )

G42 Healthcare Launches Health AI Services to Accelerate COVID-19 Diagnosis and Drug Discovery (May 19, 2020) Sec1-91

United Arab Emirates

International Holdings Company PJSC ( www , Diversified Financial Services )

UAE develops laser-based technology for faster, mass-scale coronavirus screening (May 22, 2020) Sec1-93

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

United Kingdom Aladdin Healthcare Technologies SE ( www , Healthcare Services )

Aladdin Healthcare Technologies SE achieves further milestone in COVID-19 drug development: Discovery of 20 new optimized compounds with AI DD platform (May 20, 2020)

Sec1-37

United Kingdom Avacta Group plc ( www , AVCT , Biotechnology , LargeCap )

Avacta and Medusa19 Enter into a Distribution Agreement for COVID-19 Antigen Test (May 20, 2020) Sec1-2

United Kingdom Behold.ai Technologies Limited ( www , Medical Devices )

Behold.ai partners with Apollo Hospitals Group, India for rapid COVID-19 diagnosis using AI-based chest X-ray technology (May 18, 2020)

Sec1-90

United Kingdom Europlaz Technologies Ltd ( www , Medical Devices )

Europlaz Technologies Ltd secures contract to manufacture COVID-19 Test Kits (May 20, 2020) Sec1-69

United Kingdom Genedrive plc ( www , GDR , Medical Devices , SmallCap )

Genedrive® 96 SARS-CoV-2 Kit receives CE-IVD Mark (May 22, 2020) Sec1-81

United Kingdom Independent General Practice ( www , Healthcare Services ) IGP Launches COVID-19 Antibody Home Tests (May 22, 2020) Sec1-10

United Kingdom Innovative Trials Ltd ( www , Healthcare Services )

Clinical trials company calls for unity and action to address lack of patient diversity in research (May 20, 2020) Sec1-47

United Kingdom Open Orphan PLC ( www , ORPH , Pharmaceuticals , LargeCap )

Open Orphan launches £12m equity raising to fund Covid-19 tests, models (May 22, 2020) Sec1-64

United Kingdom Oxford Immunotec Global PLC ( www , OXFD , Biotechnology , SmallCap )

Oxford Immunotec releases the T-SPOT® Discovery™ SARS-CoV-2 kit for research into measuring the T cell immune response to SARS-CoV-2, which may offer new insights into immunity to COVID-19 (May 19, 2020)

Sec1-53

United Kingdom Oxford Nanopore Technologies Limited ( www , Biotechnology )

Oxford Nanopore Technologies announces advanced development of LamPORE, for rapid, highly scalable, low-cost COVID-19 detection (May 22, 2020)

Sec1-18

United Kingdom University of Bristol ( www , Academic Institution )

Observational Study Aims To Identify Biomarkers That Could Predict COVID-19 Outcome (May 19, 2020) Sec1-54

United Kingdom University of Glasgow ( www , Academic Institution )

Glasgow heart scientists fast-track coronavirus research (May 20, 2020) Sec1-56

United States 23andMe, Inc ( www , Biotechnology ) 23 and Me expands COVID-19 genetics study (May 21, 2020) Sec1-34

United States Aegea Biotechnologies, Inc. ( www , Biotechnology )

Aegea Biotechnologies, Inc. Announces The Issuance Of 7 Additional Key U.S. Patents Relating To Its Core, Next Generation Nucleic Acid Clinical Diagnostic Technologies And Covid-19 Test Development (May 18, 2020)

Sec1-13

United States Aetion, Inc. ( www , Software ) Aetion and FDA Team Up for RWE Study to Advance Understanding of COVID-19 (May 19, 2020) Sec1-36

United States Aldeyra Therapeutics Inc ( www , ALDX , Biotechnology , LargeCap )

Aldeyra Therapeutics to Advance ADX-1612, an Investigational New HSP90 Inhibitor with Potential Nanomolar Potency Against SARS-CoV-2, to Clinical Testing for COVID-19; ADX-629 Accepted for BARDA CoronaWatch Meeting (May 20, 2020)

Sec1-14

United States Babson Diagnostics, Inc ( www , Healthcare Services )

Babson Diagnostics Enters Collaborative Research Agreement with Dell Medical School to Study Immune Response to COVID-19 (May 20, 2020)

Sec1-38

United States Best Chance Products, LLC ( www , Pharmaceuticals )

Best Chance Products, LLC Named Exclusive Distributor For BioCore Co., Ltd.'s COVID-19 PCR Test (May 22, 2020) Sec1-76

United States BioAegis Therapeutics, Inc. ( www , Biotechnology )

Study of BioAegis’ Lead Product, Gelsolin, is Key Component of NIAID Strategic Plan for COVID-19 Research (May 21, 2020) Sec1-39

United States Biodesix, Inc ( www , Biotechnology )

Biodesix Partners with Bio-Rad to Launch a Serology Test to Detect Coronavirus (COVID-19) Antibodies (May 19, 2020) Sec1-3

United States Bio-Techne Corp ( www , TECH , Biotechnology , MidCap )

Bio-Techne And Kantaro Biosciences Announce Partnership To Develop And Scale Production Of Covid-19 Serology Test (May 19, 2020)

Sec1-67

United States Blanchard Valley Health System ( www , Healthcare Services )

BVHS introduces antibody testing, plasma treatment for COVID-19 (May 18, 2020) Sec1-4

United States Brigham And Women's Hospital ( www , Healthcare Services )

Large International Study of Chloroquine for COVID-19 Shows No Benefit and Significant Harm (May 22, 2020) Sec1-40

United States Bronson Health Care Group ( www Bronson Healthcare launches antibody testing for coronavirus (May Sec1-5

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no. , Healthcare Services ) 22, 2020)

United States Centers for Disease Control and Prevention (CDC) ( www , Research Institute )

CDC to Launch Massive Population-based Antibody Testing for SARS-CoV-2 (May 19, 2020) Sec1-6

United States Chan Soon-Shiong Institute of Molecular Medicine ( www , Research Institute )

Windber institute launches COVID-19 antibody research project (May 20, 2020) Sec1-41

United States Cleveland Clinic Florida ( www , Healthcare Services )

Cleveland Clinic Akron General to Open COVID-19 Testing Site in Akron (May 19, 2020) Sec1-23

United States Cleveland Clinic Florida ( www , Healthcare Services ) Vitamin C, Zinc to be studied as COVID-19 treatment (May 22, 2020) Sec1-42

United States Columbus Regional Research Institute, LLC ( www , Research Institute )

COVID-19 clinical trial testing underway in Columbus (May 18, 2020) Sec1-43

United States Curative Inc. ( www , Biotechnology )

COVID-19 Testing Provider Curative Acquires KorvaLabs (May 19, 2020) Sec1-68

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Expands Statewide COVID-19 Response By Opening 12 Additional New Drive-Thru Test Sites in Massachusetts (May 21, 2020)

Sec1-24

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Opens 14 New Drive-Thru Test Sites in California as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States CVS Health Corp ( www , CVS , Healthcare Services , LargeCap )

CVS Health Opens 44 New Drive-Thru Test Sites in Texas as Part of Nationwide COVID-19 Response (May 21, 2020) Sec1-

United States Emory University ( www , Academic Institution )

Emory research points to success of neutralizing antibodies in the COVID-19 fight (May 20, 2020) Sec1-44

United States Enzo Biochem, Inc. ( www , ENZ , Commercial Services , LargeCap )

Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV- 2 IgG Antibody Under FDA’s Emergency Use Authorization (May 20, 2020)

Sec1-78

United States Everly Well, Inc. ( www , Healthcare Services )

Everlywell COVID-19 Test Home Collection Kit receives first FDA Emergency Use Authorization of its kind (May 18, 2020) Sec1-79

United States Fitbit Inc ( www , FIT , Medical Devices , LargeCap )

Fitbit launches COVID-19 wearables study for early detection algorithm (May 22, 2020) Sec1-45

United States FlowMetric Diagnostics, Inc. ( www , Medical Devices )

FlowMetric Diagnostics, Inc. Announces the Expansion of Their Core Services to Include Serological Antibody Testing for SARS-CoV-2 Exposure (May 21, 2020)

Sec1-9

United States Fulgent Genetics Inc ( www , FLGT , Biotechnology , SmallCap )

Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus that Causes COVID-19 (May 18, 2020)

Sec1-80

United States Gentueri Inc ( www , Biotechnology ) Gentueri Inc. to develop COVID-19 oral testing kits (May 21, 2020) Sec1-27

United States Gold Standard Diagnostics, Inc ( www , Biotechnology )

Gold Standard Diagnostics Multiplex Real-Time PCR Assay for SARS-CoV-2 Pathogen Detection Now Available in the US (May 18, 2020)

Sec1-74

United States Icahn School of Medicine at Mount Sinai ( www , Academic Institution ) New study sheds light on IBD patients with COVID (May 18, 2020) Sec1-46

United States Indica Labs Inc ( www , Biotechnology )

Indica Labs, Octo, and Axle Work with NIH to Launch a Global COVID-19 Digital Pathology Repository (May 21, 2020) Sec1-92

United States iSpecimen, Inc. ( www , Biotechnology )

iSpecimen® and myOnsite HealthCare deploy mobile phlebotomy to help advance research during the coronavirus pandemic (May 20, 2020)

Sec1-48

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL providing critical assistance in addressing national swab shortage for COVID-19 testing (May 20, 2020) Sec1-49

United States Lawrence Livermore National Laboratory ( www , Research Institute )

LLNL makes COVID-19 research public through new searchable data portal (May 19, 2020) Sec1-

United States MagnaCare ( www , Healthcare Services )

MagnaCare and BioReference Laboratories Bring COVID-19 Antibody Testing to New York Labor Groups (May 18, 2020) Sec1-28

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Country Company/Institute/Organization (www) News Details Section 1 -

Serial no.

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai Health System and Renalytix Form Joint Venture, Kantaro Biosciences, To Develop and Scale Production of COVID Antibody Test Kits (May 19, 2020)

Sec1-70

United States Mount Sinai Health System ( www , Healthcare Services )

Mount Sinai First in U.S. to Use Artificial Intelligence to Analyze Coronavirus (COVID-19) Patients (May 19, 2020) Sec1-94

United States Nanome, Inc ( www , Software ) Scientists Use Virtual Reality to Refine New AI-Generated Drugs for COVID-19 (May 21, 2020) Sec1-51

United States Nephron Pharmaceuticals Corporation ( www , Pharmaceuticals )

Nephron, One Medical Partner To Offer Covid-19 Testing Services (May 21, 2020) Sec1-95

United States OraSure Technologies, Inc. ( www , OSUR , Medical Devices , LargeCap )

OraSure’s OMNIgene®·ORAL Kit Included in EUA Granted to P23 Labs for At-Home Collection of Saliva Samples for SARS-CoV-2 Test (May 22, 2020)

Sec1-85

United States Pathnostics ( www , Healthcare Services )

Pathnostics Launches COVID-19 PCR Laboratory Test Designed to Detect Acute Infection (May 20, 2020) Sec1-19

United States Philips North America LLC ( www , Electronics )

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications (May 19, 2020) Sec1-96

United States Quidel Corporation ( www , QDEL , Pharmaceuticals , MidCap )

Quidel’S Lyra® Direct Sars-Cov-2 Assay Receives Emergency Use Authorization And Ce Mark For Molecular Detection Of Covid-19, Without Extraction Step (May 18, 2020)

Sec1-86

United States Sharecare Inc ( www , Healthcare Services )

Sharecare and Augusta University forge public-private partnership to accelerate Georgia's recovery from COVID-19 (May 23, 2020) Sec1-32

United States Sherlock Biosciences Inc ( www , Biotechnology )

Sherlock Biosciences Launches Innovation Lab to Develop COVID-19 Diagnostics with $7.5 Million Grant from Open Philanthropy (May 21, 2020)

Sec1-65

United States St. Joseph Mercy Hospital ( www , Healthcare Services )

St. Joseph Mercy launches $20M COVID-19 testing and treatment centre (May 23, 2020) Sec1-33

United States SunBeam Laboratories LLC ( www , Pharmaceuticals )

Homeland Security Seizes Large Amount Of Mislabeled COVID-19 Test Kits and PPI Supplies (May 23, 2020) Sec1-88

United States Sunquest Information Systems Inc. ( www , Healthcare Services )

Sunquest WorldCare™ Disease Surveillance, Outbreak, and Management Solution Enables Rapid Response to COVID-19 (May 21, 2020)

Sec1-97

United States University of California, Berkeley ( www , Academic Institution )

UC Berkeley: Scientists Pivot To Coronavirus Research, Hoping For Quick Results To Deal With Pandemic (May 19, 2020) Sec1-55

United States University of California, Los Angeles ( www , Academic Institution )

Team to develop Breathalyzer-like diagnostic test for COVID-19 (May 21, 2020) Sec1-21

United States University of Notre Dame ( www , Academic Institution )

Researchers work to quantify the human immune response to COVID-19 (May 18, 2020) Sec1-57

United States Verily Life Sciences LLC ( www , Biotechnology )

Verily seeks to establish new COVID-19 'Baseline' with coronavirus antibody research project (May 18, 2020) Sec1-59

United States Vitalant Research Institute ( www , Research Institute )

CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas (May 19, 2020) Sec1-60

Compiled by: VaccineWeWin.com Address: 121 Newark Ave, Suite 526, Jersey City, NJ 07302 United States Website: www.VaccineWeWin.com

We offer a report on healthcare licensing deals entered into during 2020 by the COVID-19 vaccine developers worldwide, comprehensively compiled and curated from global as well as regional and local news media. Further, the report also summarizes previous healthcare licensing deals entered into during 2019 by these COVID-19 vaccine developers worldwide to analyze their prior licensing agreements. Please visit here for more information.

We offer a report on healthcare licensing deals entered into during 2020 by the non-COVID-19 vaccine developers worldwide, comprehensively compiled and curated from global as well as regional and local news media. Further, the report also summarizes previous healthcare licensing deals entered into during 2019 by these non-COVID-19 vaccine developers worldwide to analyze their prior licensing agreements. Please visit here for more information.

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COVID-19 Diagnostics/Devices Advances News: Weekly Summary May 18 - 23, 2020

Disclaimer: COVID-19 Diagnostics/Devices Advances News: Weekly Summary is based on public domain information believed to be reliable, but no warranties are provided.

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