19-21 May 2020 | 8th Annual Diagnostics

DxInnovationSummit.com

Register by 21 February SAVE up to €300

Formerly the Molecular Diagnostics Europe Event

19-21 May 2020 | Lisbon, Portugal | Marriott Hotel Lisbon

Diagnostics8th Annual

Innovation SummitDeveloping Rapid Tests and Liquid Biopsies

Conference Programs Selected Keynote PresentationsAdvanced Diagnostics for Infectious Disease

Enabling Technologies for Liquid Biopsy and Beyond - Part I

Point-of-Care Diagnostics

Enabling Technologies for Liquid Biopsy and Beyond - Part II

EVENT FEATURES• Over 80 Presentations• 6 Keynote Presentations• Latest Tools and Applications for Liquid Biopsy,

Infectious Diseases and Point-of-Care Products• Dedicated Networking and Exhibit Hours

SHORT COURSESTechnologies, Applications and Commercialisation of Point-of-Care Diagnostics

Biomarkers in Liquid Biopsy: CTCs, ctDNA and Exosomes

Corporate Sponsors

Anders Wolff, PhD Professor, Department of Biotechnology and Biomedicine, Technical University of Denmark, Denmark

Klaus Pantel, MD Professor, Chairman, Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, Germany

Till Bachmann, PhD Professor, Deputy Head, Division of Infection and Pathway Medicine, Edinburgh Medical School, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom

2 | DxInnovationSummit.com

Sponsor Opportunities

PODIUM PRESENTATIONSAvailable Within the Main Agenda!Showcase your solutions to a guaranteed, targeted audience through a 15- or 30-minute presentation during a specific conference program, breakfast, lunch, or separate from the main agenda within a pre-conference workshop. Package includes exhibit space, onsite branding, and access to cooperative marketing efforts by CHI. For the luncheon option, lunches are delivered to attendees who are already seated in the main session room. Presentations will sell out quickly, so sign on early to secure your talk!

ONE-ON-ONE MEETINGSSelect your top prospects from the pre-conference registration list. CHI will reach out to your prospects and arrange the meeting for you. A minimum number of meetings will be guaranteed, depending on your marketing objectives and needs. A very limited number of these packages will be sold.

INVITATION-ONLY VIP DINNERSelect specific delegates from the pre-registration list to attend a private function at an upscale restaurant or a reception at the hotel. From extending invitations, to venue to suggestions, CHI will deliver your prospects and help you make the most of this invaluable experience.

ADDITIONAL BRANDING & PROMOTIONAL OPPORTUNITIES INCLUDE:• Conference Tote

Bags• Literature

Distribution (Tote Bag Insert or Chair Drop)

• Badge Lanyards• Padfolios• Program Guide

Advertisement• Meter Boards• Water Bottles

LOOKING FOR ADDITIONAL WAYS TO DRIVE LEADS TO YOUR SALES TEAM?CHI’s Lead Generation Programs will help you obtain more targeted, quality leads throughout the year. We will mine our database of 800,000+ life science professionals to your specific needs. We guarantee a minimum of 100 leads per program! Opportunities include:• Live Webinars• White Papers

• Market Surveys• Podcasts and More!

For more information, please contact:

COMPREHENSIVE SPONSORSHIP packages allow you to achieve your objectives before, during, and long after the event. Signing on earlier will allow you to maximize exposure to hard-to-reach decision-makers.

COMPANIES A-KJon Stroup Sr. Manager, Business [email protected]

COMPANIES L-ZAshley Harvey Manager, Business [email protected]

Company Type

IVD & Pharma 49% Academic Labs 17% Healthcare Provider 14% Healthcare 10% Government 4% Services 3% Financial 1% Societies 1% Other 1%

Geographic Location

USA + Canada 21% Germany 16% United Kingdom 9% The Netherlands 8% Rest of Europe 7% Asia 7% Switzerland 6% France 6% Rest of World 6% Belgium 5% Italy 3% Portugal 3% Denmark 3%

Delegate Title

Executive & Director 34% Manager 14% Professor 9% Scientist/Technologist 23% Sale & Marketing 16% Assistant 4%

2019 Attendee Demographics

Corporate Sponsors

Corporate Support Sponsors

Afternoon Short Courses*MONDAY, 18 MAY 2020 | 14:00-17:00

SC1: Technologies, Applications and Commercialisation of Point-of-Care DiagnosticsThis short course will provide an overview on the technological aspects of POC system developments. It will introduce current technologies such as microfluidics, sensors, paper- and smartphone-based approaches and discuss their trends and limitations. The course will discuss a variety of POC systems in different stages of their development, from early stage to established diagnostic systems in the clinical routine. Market aspects of POC systems as well as practical examples of commercialization for molecular diagnostic, immunological and clinical tests will be presented.Instructor:Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany

SC2: Biomarkers in Liquid Biopsy: CTCs, ctDNA and ExosomesBiomarkers for early disease detection, therapeutic efficacy monitoring and outcome prediction are the key to precision medicine. Liquid biopsy studies disease biomarkers in body fluids and can be paramount for precision medicine in cancer. The analysis of biomarkers in peripheral blood improves cancer diagnosis and treatment success. This course will give you a comprehensive overview and update on the established biomarkers, available technologies and clinical applications of liquid biopsy.Instructors:Lorena Diéguez, PhD, Group Leader, Department of Life Sciences, Nano4Health Unit, Medical Devices Research Group, International Iberian Nanotechnology Laboratory, PortugalRoberto Piñeiro Cid, PhD, Cancer Modeling Lab, Instituto de Investigación Sanitaria de Santiago de Compostela, Roche-Chus Joint Unit, Spain

*Separate registration required

Lisbon Marriott HotelAvenida dos Combatentes, 45Lisbon 1600-042 PortugalPhone: (351)(21) 723 5400

Discounted Room Rate: €189 single/€199 double, includes breakfast

Discounted Room Rate Cut-off Date: 10 April 2020

For more information: DxInnovationSummit.com/travel

HOTEL & TRAVEL INFORMATION

Media Sponsors

Official Event Publication

Diagnostics WorldLead Sponsoring Publications Sponsoring Publications

Clinical Trials to the Clinic

CLINICALRESEARCHNEWS

Lead Media Partners Web Partner

Sponsoring Partner

DxInnovationSummit.com | 3


Cambridge Healthtech Institute’s 6th Annual 19-20 MAY 2020

Advanced Diagnostics for Infectious DiseaseNew Frontiers in Infectious Disease Diagnostics

MONDAY 18 MAY

Recommended Short Course*

SC1: Technologies, Applications and Commercialisation of Point-of-Care Diagnostics*Separate Registration required. See page 3 for details.

TUESDAY 19 MAY

FEATURED SESSION: EMERGING AND RE-EMERGING PATHOGENS

08:00 Registration and Morning Coffee

08:55 Organizer’s Opening RemarksKaitlyn Barago, Project Manager, Production Initiatives, Cambridge Healthtech Institute, United States

09:00 Chairperson’s RemarksFrançois Jean, PhD, Associate Professor, Microbiology and Immunology, University of British Columbia; Team Leader, NSERC CRD Grant in 3-D Brain Organoid Models of Arboviral Diseases; Co-Founder, Canadian Network of Scientific Platforms, Canada

09:05 Diagnostics for Epidemic Preparedness: Disrupt to DeliverCassandra Kelly-Cirino, PhD, Director, Emerging Threats, FIND, SwitzerlandDiagnostics to address new and ongoing epidemics are critically needed; however, innovation and development is hampered by the episodic nature of the outbreaks coupled with generally small volume needs annually. Changes are needed to how we approach development and access to diagnostics to ensure countries with the highest need have access to sustainable, affordable and high quality products.

09:35 Ebola Virus – Pathogenesis & CountermeasuresAndrea Marzi, PhD, Chief, Immunobiology & Molecular Virology Unit, Laboratory of Virology, DIR, NIAID, NIH, United StatesHighly pathogenic viruses continue to pose a significant threat to humans with their potential to cause global public health crises. In 2014, such a crisis was barely circumvented by the global commitment of resources to fight the Ebola virus (EBOV) epidemic that devastated West Africa and spread to Nigeria and the United States. Although there is still no licensed EBOV treatment available, Europe, China and Russia have licensed EBOV vaccines that will hopefully help prevent future outbreaks.

Sponsored by10:05 Presentation to be Announced

10:20 Sponsored Presentation (Opportunity Available)

10:35 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

COMBATING ANTIMICROBIAL RESISTANCE11:15 Chairperson’s RemarksJohn Hays, PhD, Associate Professor, Medical Microbiology & Infectious Diseases, Erasmus University Medical Center Rotterdam, The Netherlands

11:15 The Impact of the Internet of Things in Combatting Antibiotic ResistanceJohn Hays, PhD, Associate Professor, Medical Microbiology & Infectious Diseases, Erasmus University Medical Center Rotterdam, The NetherlandsThe world is becoming more interconnected, with a future where household and medical devices can communicate with each other (the ‘Internet-of-Things’). However, this interconnectivity brings with it both potential advantages and disadvantages with respect to maintaining and improving societal and hospital-based healthcare. This presentation will identify some of the current and potential future applications of IoT technologies on the struggle against increasing global antibiotic resistance.

11:45 Developing a Novel Smartphone-Based Diagnostic System for Point-of-Care Detection of Infectious Diseases and Antimicrobial ResistanceJesus Rodriguez Manzano, PhD, Lecturer in Antimicrobial Resistance and Infectious Diseases, Faculty of Medicine, Imperial College London, United KingdomSmartphone-based diagnostics for infectious diseases has become a promising field enabling the delivery of precise diagnostics near the patient and in limited-resource settings. Although smartphones provide a user-friendly interface, cloud connectivity, and strong computational power, they are currently coupled with non-portable and expensive diagnostic platforms, typically based on fluorescent or colorimetric detection. This work demonstrates a smartphone-based platform for nucleic acid detection at the point-of-care, replicating the function of conventional lab-based quantitative PCR instruments. This is achieved by coupling semiconductor technology for non-optical real-time DNA sensing with isothermal amplification chemistries, reducing the need for complex and costly thermal management. Adoption of this platform will decrease the turnaround time for detection of nucleic acids, improving diagnostic capabilities, patient outcomes, and the management of infectious diseases and antimicrobial resistance.

12:15 Does the Current Armoury of Rapid Diagnostic Tests Really Help Clinicians Reduce Unnecessary Antibiotic Prescribing for Respiratory Tract Infections?Sanjay Patel, Consultant, Paediatric Infectious Diseases and Immunology, Paediatrics, South Hampton Children’s Hospital, United KingdomMost diagnostic test manufacturers have focused their attention on distinguishing viral from bacterial infections. Unfortunately, there is very little data to suggest that such tests have a significant impact on antibiotic prescribing. Instead, the development of tests that provide information on which patients will benefit from antibiotics is proposed. However, it is necessary to optimise the current prescribing landscape before the benefits of such tests can be realised.


Sponsored by13:15 LUNCHEON PRESENTATION: Commercialisation of an IVD in a Changing Global EnvironmentLynn Stephenson, PhD, Marketing Manager, Dx Manufacturing & OEM, MilliporeSigma, United StatesChanges in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing capabilities is one strategy diagnostics companies can use to mitigate risk. A well-chosen CM partner can accelerate the commercialisation process by anticipating potential roadblocks. In this session, we will discuss best practices and key considerations for vetting contract manufacturing partners.

13:45 Session Break


Advanced Diagnostics for Infectious Disease

BIOMARKERS FOR INFECTIOUS DISEASE14:15 Chairperson’s RemarksClare Morris, Principal Scientist, Division of Infectious Disease Diagnostics, National Institute for Biological Standards and Control, United Kingdom

14:20 FEATURED PRESENTATION: A Universal Cancer Assay With Applications in Infectious Disease: Are We There Yet?Matt Trau, PhD, Deputy Director and Co-Founder, Australian Institute for Bioengineering and Nanotechnology; Professor, Chemistry, University of Queensland, AustraliaThe Centre for Personalised Nanomedicine at UQ is focused on translating nanotechnologies into a clinical setting, whilst developing the next generation of point-of-care diagnostic technologies to further empower the personalised and precision medicine approach. Our consortium recently published hundreds of epigenetic regions that are highly informative in cancer, as well as a unique epigenetic marker that appears to be universal for cancer. In this talk we will present data on the clinical translation of this approach, highlighting some of the positive impacts that such an approach can make. Along with comprehensive DNA/RNA/methylated-DNA sequencing methodologies, several point-of-care nanotechnologies recently developed by our lab will be presented.

14:45 Liquid Biopsy for Neuroinvasive Arbovirus DiseasesFrançois Jean, PhD, Associate Professor, Microbiology and Immunology, University of British Columbia; Team Leader, NSERC CRD Grant in 3-D Brain Organoid Models of Arboviral Diseases; Co-Founder, Canadian Network of Scientific Platforms, CanadaArboviruses such as Zika (ZIKV) virus are responsible for a significant health burden worldwide. Dr. Jean will present the development of “liquid biopsy” for ZIKV-associated neurological diseases. With the recent discovery of circulating extracellular vesicles (EVs) and their important cellular functions in arboviral infections and diseases, we hypothesize that brain-derived (BD) EVs released during viral infection represent unexplored treasure troves of potential host-biomarkers for neuroinvasive arboviral diseases. We will report the molecular and biophysical characterization of BD EVs released from ZIKV-infected human cerebral organoids and discuss the impact of their findings for developing next-generation molecular diagnostics technology for neuroinvasive arbovirus infection.

15:10 How Good Is Your Assay and Can You Prove It?Clare Morris, Principal Scientist, Division of Infectious Disease Diagnostics, National Institute for Biological Standards and Control, United KingdomConsistent and effective clinical management of diseases requires comparable data generated by diagnostic assays. With each advancement of technology we see new challenges, especially in the field of molecular assays. Whilst many laboratories acknowledge the need for validated assays and calibrated controls, there is great variation in methods to determine assay accuracy. Thus, even though a standard may exist, it serves little function if not used correctly. This presentation will address the application of these types of reference materials linked to a primary physical reference. “The International Standard”, wherever possible, can provide assurance of the quality of the data and, in turn, support improved clinical management of patients.

15:30 Development of Proteomic Signatures for Use in Precision MedicineAnthony Whetton, PhD, Director, Stoller Biomarker Discovery Centre, University of Manchester, United KingdomPrecision medicine is a key objective in improving healthcare. The use of innovations in MS-based technologies offers a high capacity throughput proteomic profiling for clinical biochemistry purposes, as has been achieved at the Stoller Biomarker Discovery Centre. For example, markers of risk in ovarian cancer and response to therapy in schizophrenia have been investigated using a Data Independent Acquisition (DIA) mass spectrometry approach, among other uses. Combined with validation platforms, this approach offers a quicker route to mechanistic detail/drug targets plus biomarkers for risk and stratification. New approaches to biomarker discovery are also coming to the fore using artificial intelligence approaches.

Sponsored by15:50 Lyophilization Solutions for Assay DevelopersPeter Holden, PhD, Senior Business Development Manager, Licensing and Commercial Supply, Thermo Fisher Scientific, United States Lyophilization has become increasingly popular among assay developers because it offers advantages in terms of ease of use, shelf life, and ambient temperature during shipping and storage. Now, Thermo Fisher Scientific can provide your assay to you in a lyophilized format, ready to ship to your customers. Learn about how you can streamline your supply chain by partnering with us on assay development and manufacturing.

16:20 Refreshment Break in the Exhibit Hall with Poster Viewing

17:00 Breakout Discussions (Visit www.dxinnovationsummit.com/Breakout-Discussions for details)

18:00 Welcome Reception in the Exhibit Hall with Poster Viewing

19:00 Close of Day

WEDNESDAY 20 MAY

COMPARING AND CONTRASTING METHODS08:00 Registration and Morning Coffee

09:00 Chairperson’s RemarksVanessa Harris, MD, PhD, Assistant Professor, Global Health, University Medical Center, University of Amsterdam, Amsterdam Institute for Global Health and Development, The Netherlands

09:05 Advanced and Conventional Methods for the Identification of Infectious Agents: Have Ones Replaced the Others?Adriana Calderaro, MD, PhD, Associate Professor, Clinical Microbiology, Unit of Microbiology and Virology, Department of Medicine and Surgery; Director, Unit of Clinical Microbiology and Unit of Clinical Virology, Diagnostic Department, University Hospital of Parma, ItalyThe combined application of conventional and innovative methods recently introduced and applied to the practice has an important effect in the diagnosis of infectious diseases and on the clinical management of the patient. A comparison between conventional and innovative methods and among different innovative methods for the detection and identification of infectious agents, including those causing nosocomial infections, was performed.

THE EMERGING ROLE OF THE MICROBIOME IN DIAGNOSTICS

09:35 Intestinal Bacterial Microbiome as an Infectious Disease Diagnostic, Promises and PitfallsVanessa Harris, MD, PhD, Assistant Professor, Global Health, University Medical Center, University of Amsterdam, Amsterdam Institute for Global Health and Development, The NetherlandsKnowledge of and interest in the bacterial intestinal microbiome as a diagnostic and therapeutic is rapidly expanding. This talk explores the promise of the microbiome as an infectious disease diagnostic as well as the challenges, using our work evaluating the bacterial intestinal microbiome’s correlation with oral vaccine immunogenicity.


Advanced Diagnostics for Infectious Disease

10:05 Developing Global Standards for the MicrobiomeGregory Amos, PhD, Senior Scientist, Bacteriology, National Institute for Biological Standards and Control, United KingdomEffective standardisation of the microbiome methodologies is essential to the entire microbiome community. We will describe the development of the first reference reagents and quality reporting framework produced by the National Institute for Biological Standards and Control, which are candidates for the first World Health Organization International Reference reagents for NGS analysis of the microbiome. Widespread adoption of the standards could effectively standardise downstream gut microbiome analyses allowing commutability across assays and studies.


11:05 Coffee Break in the Exhibit Hall with Poster Viewing


12:35 Session Break

KEYNOTE SESSION14:00 Keynote Introduction

Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center, United States

14:05 Rapid AMR Detection and Rapid Antimicrobial Susceptibility Testing – Two Sides of the Same Coin in the Fight against AMR?

Till Bachmann, PhD, Professor, Deputy Head, Division of Infection and Pathway Medicine, Edinburgh Medical School, College of Medicine and Veterinary Medicine, University of Edinburgh, United Kingdom

Rapid diagnostics is considered a key tool to tackle antimicrobial resistance. While rapid molecular diagnostics of pathogens and antimicrobial resistance is established as a strong contender of traditional culture-based pathogen identification and susceptibility testing, its strengths lie in the determination of which antibiotics to avoid. Rapid antimicrobial susceptibility testing to find out which antibiotic to use is emerging at rapid pace using innovative techniques for phenotypic testing. The presentation will discuss the current landscape and emerging opportunities of these two leading diagnostic perspectives.

14:35 The Longitude Prize: Overcoming Hurdles to Market for AMR Point-of-Care Diagnostics

Caroline Purslow, Global Health Programme Manager, Nesta Challenges United KingdomUse of point-of-care diagnostic tests would reduce the

overuse and misuse of antibiotics. Innovation in this area is moving at a rapid pace, yet few of these products have reached clinicians. The Longitude Prize was created to stimulate this innovation, yet without removing barriers to market access and implementation, a winning test cannot have the desired impact. This talk will provide an update on the Longitude Prize portfolio and the steps the project and wider community are undertaking to ensure novel point-of-care diagnostics reach the front-line.

15:05 Chest Infection. Are You Sure You Need Those Antibiotics?

Liz Cross, Advanced Nurse Practitioner, QN, Attenborough Surgery, Bushey Medical Centre, Herts Valleys Clinical Commissioning Group, NIHR, United KingdomThe outlying 5 highest antibiotic prescribing practices

within Hert Valley CCG were selected and offered C-reactive protein (CRP) point-of-care-testing (POCT) as an intervention to aid them to reduce their antibiotic prescribing. These practices were provided with CRP machines for a one-year period, along with education. A practice champion in each surgery was identified who helped staff to engage with using the CRP POCT machine and who could help with identified problems, especially in the early stages. CRP POCT was not offered to every patient, just those cases where the GP had some reservations about the need for a prescription. The results show that 81% of patients offered CRP POCT did not receive antibiotics and 92% of patients did not reattend the practice within 28 days after having received a CRP POCT. We believe that if CRP POCT was not available then the majority of these patients would have been prescribed antibiotics. CRP POCT has therefore proven to be a beneficial tool in these high prescribing practices to reduced unscheduled reattendances and supporting GPs to use antibiotics more effectively.

15:35 Close of Advanced Diagnostics for Infectious Disease



Enabling Technologies for Liquid Biopsy and Beyond - Part IDeveloping Novel Assays for Circulating Biomarkers and Clinical Use

MONDAY 18 MAY

Recommended Short Course*

SC2: Biomarkers in Liquid Biopsy: CTCs, ctDNA and Exosomes*Separate Registration required. See page 3 for details.

TUESDAY 19 MAY

THE IMPORTANCE OF BIG DATA IN LIQUID BIOPSY08:00 Registration and Morning Coffee

08:55 Organizer’s Opening RemarksKaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute

09:00 Chairperson’s RemarksMichael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath, Distinguished Research Professor, Clinical Pharmacology, University Medical Center Goettingen (UMG), Germany

09:05 The First WHO International Standards for Circulating Tumour DNA: Towards Global Harmonisation of Liquid Biopsy MeasurementAngela Pia Sanzone, PhD, Blood Biomarkers Group Leader, Advanced Therapies Division, National Institute for Biological Standards and Control (NIBSC), ItalyThe adoption of ctDNA measurement into routine clinical practice would be strengthened by the availability of internationally recognized reference standards, enabling harmonised reporting in diagnostics and patient monitoring. NIBSC (UK) is developing WHO International Standards for ctDNA, initially for EGFR variants, intended to be maximally commutable, and complementing in parallel-developed genomic DNA standards for direct solid tumour diagnostics, thus facilitating accurate, consistent measurement of cancer biomarkers in liquid biopsy.

UPDATES IN LIQUID BIOPSY TECHNOLOGIES09:35 Fragmentomics as Novel Strategy to Characterize Circulating DNA: Application to Cancer ScreeningAlain Thierry, PhD, Director of Research, Biomarkers for Precision Oncology, IRCM/INSERM, FranceMost of nuclear circulating DNA (cirDNA) is highly fragmented upon chromatin organization and protection/packaging within mononucleosomes, as the lowest unit and the most stabilized structure in the blood stream. Size pattern characterization or fragmentomics is related to the nucleosomal packing of DNA and the interaction with histone proteins. Fragmentomics may determine tissue-of-origin, and as well classify fetal and cancer derived cirDNA vs healthy individuals. This confirmed our earlier hypothesis that fragmentomics is a strategy to characterize cancer individuals appearing as an alternative or a synergistic supplement to searching mutations, methylation or nucleosome positioning to further improve diagnostics and cancer screening.



10:35 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

UPDATES IN LIQUID BIOPSY TECHNOLOGIES11:15 Enabling Technologies for Low-Cost and Efficient Targeted Re-Sequencing for Liquid Biopsy ApplicationsG. Mike Makrigiorgos, PhD, Professor, Radiation Oncology, Dana-Farber Cancer Institute and Harvard Medical School, United StatesAs the potential of liquid biopsies for prognostic, predictive or early cancer detection applications grows, so does the demand for technical

advances to accompany the burgeoning range of applications. We present new developments that enable targeted re-sequencing for liquid biopsy applications at a fraction of the current cost, while retaining or increasing sensitivity and specificity. Examples for detecting low-level mutations in circulating DNA will be presented.

11:45 Detection of Point Mutations in Liquid and Tissue Biopsy Using an Acoustic Wave Array PlatformNikoletta Naoumi, MSc, PhD Student, IMBB-FORTH, GreeceThe project concerns the development of a novel ultra-sensitive diagnostic method for the detection of single-copy point mutations in circulating and genomic tumor DNA for liquid and tissue biopsy, respectively. The approach involves the use of a highly sensitive and specific allele-specific PCR assay combined for the first time with an acoustic biosensor. The work is part of the CATCH-U-DNA EU-funded Horizon2020 FET-OPEN project.

12:15 New Markers to Highlight Circulating Tumor DNA for Colon Cancer Patient Follow-UpGeoffrey Poulet, PhD Student, Valerie Taly’s Lab, Translational Research and Microfluidics, Eurofins-BIOMNIS, FranceRecent technological developments including droplet-based digital PCR and optimized NGS have greatly facilitated the tracking of circulating cell-free nucleic acids in body effluents. Strategies dedicated to the detection of circulating tumor DNA based on multiple innovative markers, such as DNA hypermethylation or DNA integrity, will be presented. In particular, we will illustrate the pertinence of these approaches for the follow-up of patients with localized or advanced colorectal cancers.

Sponsored by12:45 Nu.QTM Complete – Comprehensive Nucleosome ProfilingMark Eccleston, PhD, MBA, Director, Business Development, Volition, BelgiumVolition is utilising epigenetic profiling of cell-free, circulating nucleosomes using simple Nu.Q immunoassays to develop blood tests for early detection of a range of cancers. We now present a broader analytical approach, employing immuno-capture, mass spectrometry, immunoassay and sequencing of constituent DNA to allow comprehensive analysis of circulating nucleosomes of tumor origin.

Sponsored by13:15 LUNCHEON PRESENTATION: Advances in CTC Isolation and Characterisation Using the Epitope-Independent Parsortix SystemAnne-Sophie Pailhes-Jimenez, R&D Group Leader, Cell Biology and Imaging – R&D, ANGLE plc, United KingdomCirculating tumor cells (CTCs) can provide access to protein and genetic information on patient cancer through a simple blood draw. The enumeration of CTCs has shown prognostic relevance in several cancer types. The Parsortix system allows epitope-independent capture and harvest of CTCs from blood for analysis. We developed a robust workflow allowing for epithelial and mesenchymal CTC identification and characterisation from cancer patient samples using immunofluorescence. The presented workflow would provide a complete and standardised sample-to-answer imaging solution, from blood separation to images of CTCs.

13:45 Session Break

LIQUID BIOPSY FOR INFECTIOUS DISEASE14:15 Chairperson’s RemarksClare Morris, BSc, Principal Scientist, Division of Infectious Disease Diagnostics, National Institute for Biological Standards and Control, United Kingdom



14:20 FEATURED PRESENTATION: A Universal Cancer Assay With Applications in Infectious Disease: Are We There Yet?Matt Trau, PhD, Deputy Director and Co-Founder, Australian Institute for, Bioengineering and Nanotechnology; Professor, Chemistry, University of Queensland, AustraliaThe Centre for Personalised Nanomedicine at UQ is focused on translating nanotechnologies into a clinical setting, whilst developing the next generation of point-of-care diagnostic technologies to further empower the personalised and precision medicine approach. Our consortium recently published hundreds of epigenetic regions that are highly informative in cancer, as well as a unique epigenetic marker that appears to be universal for cancer. In this talk we will present data on the clinical translation of this approach, highlighting some of the positive impacts that such an approach can make. Along with comprehensive DNA/RNA/methylated-DNA sequencing methodologies, several point-of-care nanotechnologies recently developed by our lab will be presented.

14:45 Liquid Biopsy for Neuroinvasive Arbovirus DiseasesFrançois Jean, PhD, Associate Professor, Microbiology and Immunology, University of British Columbia; Team Leader, NSERC CRD Grant in 3-D Brain Organoid Models of Arboviral Diseases; Co-Founder, Canadian Network of Scientific Platforms, CanadaArboviruses (arthropod-borne viruses), such as Zika virus (ZIKV), are responsible for a significant health burden worldwide. ZIKV is now the second-most widely distributed arbovirus in the Americas. ZIKV infections produce different neurologic complications in different individuals which are difficult to diagnose virologically. Dr. Jean will present the development of “liquid biopsy” for ZIKV-associated neurological diseases. With the recent discovery of circulating extracellular vesicles (EVs) and their important cellular functions in arboviral infections and diseases, Dr. Jean’s team hypothesizes that brain-derived (BD) EVs released during viral infection represent unexplored treasure troves of potential host-biomarkers for neuroinvasive arboviral diseases. For proof-of-concept, Dr. Jean will report the molecular and biophysical characterization of BD EVs released from ZIKV-infected human cerebral organoids and discuss the impact of their findings for developing next-generation molecular diagnostics technology for neuroinvasive arbovirus infection.

15:10 How Good Is Your Assay and Can You Prove It?Clare Morris, BSc, Principal Scientist, Division of Infectious Disease Diagnostics, National Institute for Biological Standards and Control, United KingdomConsistent and effective clinical management of diseases requires comparable data generated by diagnostic assays. With each advancement of technology, we see new challenges, especially in the field of molecular assays. Whilst many laboratories acknowledge the need for validated assays and calibrated controls, there is great variation in methods to determine assay accuracy. Thus, even though a standard may exist, it serves little function if not used correctly. This presentation will address the application of these types of reference materials linked to a primary physical reference. “The International Standard”, wherever possible, can provide assurance of the quality of the data and, in turn, support improved clinical management of patients.

15:30 Development of Proteomic Signatures for Use in Precision MedicineAnthony Whetton, PhD, Director, Stoller Biomarker Discovery Centre, University of Manchester, United KingdomPrecision medicine is a key objective in improving healthcare. The use of innovations in MS-based technologies offers high-capacity throughput proteomic profiling for clinical biochemistry purposes, as has been achieved at the Stoller Biomarker Discovery Centre. For example, markers of risk in ovarian cancer and response to therapy in schizophrenia have been investigated using a Data Independent Acquisition (DIA) mass spectrometry approach, among other uses. Combined with validation platforms, this approach offers a quicker route to mechanistic detail/drug targets, plus biomarkers for risk and stratification. New approaches to biomarker discovery are also coming to the fore using artificial intelligence approaches.

Sponsored by15:50 Lyophilization Solutions for Assay DevelopersPeter Holden, PhD, Senior Business Development Manager, Licensing and Commercial Supply, Thermo Fisher Scientific, United StatesLyophilization has become increasingly popular among assay developers because it offers advantages in terms of ease of use, shelf life, and ambient temperature shipping and storage. Now, Thermo Fisher Scientific can provide your assay to you in a lyophilized format, ready to ship to your customers. Learn about how you can streamline your supply chain by partnering with us on assay development and manufacturing.



18:00 Welcome Reception in the Exhibit Hall with Poster Viewing

19:00 Close of Day

WEDNESDAY 20 MAY

BEYOND BLOOD-BASED ASSAYS: UTILIZING OTHER BIOFLUIDS


09:00 Chairperson’s RemarksLorena Diéguez, PhD, Research Group Leader, Medical Devices Research Group, Nano4Health Unit, Life Sciences Department, INL-International Iberian Nanotechnology Laboratory, Portugal

09:05 Optofluidic Systems for High-Throughput Analysis of Cancer Material in Body Fluids: Towards Personalized MedicineLorena Diéguez, PhD, Research Group Leader, Medical Devices Research Group, Nano4Health Unit, Life Sciences Department, INL-International Iberian Nanotechnology Laboratory, PortugalMicrofluidics is a powerful tool to control fluids at the microscale. Plasmonics and surface-enhanced Raman scattering spectroscopy can be used for highly sensitive molecule detection. Together, with microfluidics and plasmonics, we can build new technologies for precise isolation of tumor material from body fluids and multiplex biomarker analysis.

09:35 Saliva, Exosomes and Type 2 Diabetes DiagnosticsChrista Noehammer, PhD, Senior Scientist, Molecular Diagnostics, AIT Austrian Institute of Technology GmbH, AustriaSaliva is a readily and, even within short time intervals, repeatedly available body fluid, which can be obtained via non-invasive, painless collection. The Molecular Diagnostics research group at the AIT Austrian Institute of Technology has proven the suitability for circulating biomarker-based saliva diagnostics in a variety of proof-of-concept studies, including DNA-methylation-, miRNA-, protein- and autoantibody-based biomarkers. In the present talk, we will report on results of a research project where we have been looking for salivary and plasma exosome-derived epigenetic biomarkers for early type 2 diabetes diagnosis.

10:05 Identification of Treatment Resistance in Metastatic Prostate Cancer Patients by Leveraging Sequential Plasma Sample AnalysisDaniel Wetterskog, PhD, Senior Research Associate, UCL Cancer Institute, University College London, United KingdomThe Treatment Resistance Team at the UCL Cancer Institute has been using plasma to interrogate treatment resistance in castration-resistant prostate cancer (CRPC) and develop biomarkers for selecting treatment. Using targeted next-generation sequencing and droplet digital PCR on cfDNA from sequential plasma samples, we have identified markers of response to abiraterone, enzalutamide and chemotherapies. In the presentation, I will discuss our latest findings and ongoing treatment resistance studies.

http://www.dxinnovationsummit.com/Breakout-Discussions





11:05 Coffee Break in the Exhibit Hall with Poster Viewing


12:35 Session Break

KEYNOTE SESSION: BRINGING LIQUID BIOPSYASSAYS TO THE CLINIC

14:00 Keynote IntroductionAlain R. Thierry, PhD, Director of Research, Biomarkers for

Precision Oncology, IRCM/INSERM, France

14:05 How Can a Network Enable Liquid Biopsy Introduction into the Clinic on a Large Scale?

Klaus Pantel, MD, Professor, Chairman, Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, GermanyThe analysis of tumor cells (CTCs) and tumor cell products

(DNA, miRNA, extracellular vesicles or tumor-educated platelets) in blood can provide clinically relevant information as “liquid biopsy”. To support the translation into clinical routine, the European Liquid Biopsy Society was recently established based on the achievements of the EU/IMI sponsored consortium CANCER-ID (www.cancer-id.eu). Here, the opportunity of ELBS to transfer liquid biopsy research into clinical practice will be outlined and discussed.

14:35 Donor-Derived Cell-Free DNA Testing in Organ Transplantation: A Value Proposition

Michael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath, Distinguished Research Professor, Clinical Pharmacology, University Medical Center Goettingen (UMG), GermanyThere is a need to improve personalized

immunosuppression in organ transplantation to reduce premature graft loss. A value proposition concept was applied for donor-derived cell-free DNA testing in plasma of transplant recipients as an alternative to invasive biopsies to early detect or exclude rejections or other graft injuries. This approach allows to personalize immunosuppression and may improve outcome. Transplant physicians could provide better immunosuppressive guidance. Hospital management and insurance companies benefit from more cost-effective surveillance of transplant recipients.

15:05 Detection of Cell-Free Circulating BRAFV600E by Droplet Digital PCR in Patients with Melanocytic Cutaneous Lesions: Considerations for the Clinical Implementation

Joan Anton Puig-Butille, PhD, Head, Molecular Biology CORE, Hospital Clinic of Barcelona, SpainThe p.V600E mutation in BRAF gene (BRAFV600E) is

frequently detected in melanoma and common benign naevi. We evaluated the clinical significance of detection of

BRAFV600E in plasma cfDNA (cfBRAFV600E) from melanoma patients and from patients without melanoma undergoing regular follow-up of their melanocytic lesions. The study suggests that naevus-related factors do not influence the detection of cfBRAFV600E and supports the clinical diagnostic value of cfBRAFV600E quantification in melanoma patients.





http://www.cancer-id.eu


WEDNESDAY 20 MAY

11:00 Registration


12:35 Session Break

KEYNOTE SESSION14:00 Keynote Introduction

Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center, United States

14:05 Rapid AMR Detection and Rapid Antimicrobial Susceptibility Testing – Two Sides of the Same Coin in the Fight against AMR?

Till Bachmann, PhD, Professor, Deputy Head, Division of Infection and Pathway Medicine, Edinburgh Medical School, College of Medicine and Veterinary Medicine, University of Edinburgh, United KingdomRapid diagnostics is considered a key tool to tackle

antimicrobial resistance. While rapid molecular diagnostics of pathogens and antimicrobial resistance is established as a strong contender of traditional culture-based pathogen identification and susceptibility testing, its strengths lie in the determination of which antibiotics to avoid. Rapid antimicrobial susceptibility testing to find out which antibiotic to use is emerging at rapid pace using innovative techniques for phenotypic testing. The presentation will discuss the current landscape and emerging opportunities of these two leading diagnostic perspectives.

14:35 The Longitude Prize: Overcoming Hurdles to Market for AMR Point-of-Care Diagnostics

Caroline Purslow, Global Health Programme Manager, Nesta Challenges, United KingdomUse of point-of-care diagnostic tests would reduce the

overuse and misuse of antibiotics. Innovation in this area is moving at a rapid pace, yet few of these products have reached clinicians. The Longitude Prize was created to stimulate this innovation, yet without removing barriers to market access and implementation, a winning test cannot have the desired impact. This talk will provide an update on the Longitude Prize portfolio and the steps the project and wider community are undertaking to ensure novel point-of-care diagnostics reach the front line.

15:05 Chest Infection: Are You Sure You Need Those Antibiotics?Liz Cross, Advanced Nurse Practitioner, QN, Attenborough

Surgery, Bushey Medical Centre, Herts Valleys Clinical Commissioning Group, NIHR, United KingdomThe outlying 5 highest antibiotic-prescribing practices

within Hert Valley CCG were selected and offered C-reactive protein (CRP) point-of-care-testing (POCT) as an intervention to aid them to reduce their antibiotic prescribing. These practices were provided with CRP machines for a one-year period, along with education. A practice champion in each surgery was identified who helped staff to engage with using the CRP POCT machine and who could help with identified problems, especially in the early stages. CRP POCT was not offered to every patient, just those cases where the GP had some reservations about the need for a prescription. The results show that 81% of patients offered CRP POCT did not receive antibiotics and 92% of patients did not reattend the practice within 28 days after having received a CRP POCT. We believe that if CRP POCT was not available then the majority of these patients would have been prescribed antibiotics. CRP POCT has therefore proven to be a beneficial tool in these high prescribing practices to reduced unscheduled reattendances and supporting GPs to use antibiotics more effectively.



MOLECULAR POCT GOING MAINSTREAM17:00 Chairperson’s RemarksGyorgy Abel, MD, PhD, Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center, United States

17:05 Three Novel Point-of-Care (POC) Platforms for Molecular Pathogen Testing Based on Real-Time PCR, Digital Single-Cell RPA, and Electrochemical LAMPApl. Prof. Dr. Felix von Stetten, Associate Director, Hahn-Schickard-Gesellschaft für angewandte Forschung e.V., GermanyThree POC platforms of different technology-readiness-levels (TRLs) are presented: 1) The Spindiag platform (TRL-6), performing real-time PCR-based admission screening for antibiotic-resistant bacteria (MRSA, CRO, VRE); 2) a digital sample-to-answer-platform (TRL-4) for the massively parallel analysis of single MRSA/MSSA cells for species and resistance gene; and 3) a miniaturized electrochemical platform for isothermal amplification (TRL-3) using real-time mediator displacement LAMP, recently validated with HIV-1 and HTLV-1.

17:35 Point-of-Care Diagnostic and Monitoring of Bacterial InfectionsWinnie Edith Svendsen, PhD, Professor, Department of Biotechnology and Biomedicine Section for Microbial and Chemical Ecology, Technical University of Denmark, Lyngby, DenmarkThe challenges of introducing point-of-care detection of bacterial-specific infections are plentiful. In this talk, I will discuss three examples with different challenges of bacterial infections and the technology applied to solve these challenges. I will illustrate how quorum sensing can be used to fingerprint pseudomonas infection in the lungs of cystic fibrosis patients from sputum samples using electrochemical methods. I will discuss how electrochemical impedance spectroscopy can be used to monitor the correct dosing of the antibiotic, Vancomycin, which is toxic but a last resort antibiotic for treating resistant bacterial infections in humans. Finally, I will demonstrate a simple method to monitor if a bacterial contamination exists on surfaces, e.g. for hygiene control. I will discuss the challenges, encounters, pros and cons of each method for point-of-care detection.

18:05 The Case for Grassroots Innovation in POCTGyorgy Abel, MD, PhD, Director, Molecular Diagnostics, Immunology & Clinical Chemistry, Laboratory Medicine, Lahey Hospital & Medical Center, United StatesDx innovation is commonly initiated at the top of the pyramid: major companies analyze trends, recognize unmet needs, and instruct their R&D departments to develop new or upgraded diagnostic systems. It generally works well for large, expensive platforms, but often falls short in POCT. The modest capital requirement for POCT development allows free-flowing, “outside the box” thinking and enables grassroots innovation at startups and academic incubators. Esoteric new ideas are welcome in grassroots, but often thwarted in corporate environments. Grassroots innovation has been a rich source of new POCT solutions as illustrated by examples in this presentation.

18:35 Close of Day


Point-of-Care DiagnosticsDisrupting Healthcare Delivery




Point-of-Care Diagnostics

THURSDAY 21 MAY

MICROFLUIDICS-ENABLED SOLUTIONS FOR THE POINT-OF-CARE


09:00 Chairperson’s RemarksHolger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany

09:05 Energy-Efficient and Precise Photon-Based Technology for Optical Heating and Temperature Control in a Microfluidic System for Nucleic Acid Amplification at Point-of-CareMiron Tokarski, CEO, Genomtec S.A., PolandCurrently, microfluidic systems for genetic testing are largely based on PCR technology. This approach has several problems linked with energy consumption, efficient heating and cooling, size and the high complexity of the diagnostic systems which result in limited access to genetic testing benefits. The Genomtec team has developed a unique LED-based heating system and contactless temperature detection system for use on INAAT assays in microfluidic point-of-care systems.

09:35 Automated Platform for Near-Patient, Rapid Microfluidic Extraction of Circulating Nucleic Acids from Milliliter Volumes of Whole BloodMaïwenn Kersaudy-Kerhoas, PhD, Associate Professor, Institute of Biological Chemistry, Biophysics and Bioengineering, Heriot-Watt University, United KingdomFor extracellular plasma circulating cell-free nucleic acids (CNAs) to have an impact on healthcare, a key challenge to overcome is the development of rapid and reliable low-cost sample preparation. We demonstrate a microfluidic system able to perform the extraction of circulating cell-free miRNAs and DNA from several milliliters of whole blood in a single disposable fluidic cartridge, on a fully automated platform, delivering a stable elution of CNAs in under an hour.


10:35 Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing

11:20 CRISPR-Powered Electrochemical Nucleic Acid DiagnosticsCan Dincer, PhD, Junior Research Group Leader, Freiburg Center for Interactive Materials and Bioinspired Technologies (FIT) and Department of Microsystems Engineering (IMTEK), University of Freiburg, GermanyNucleic acid testing is decisive for the diagnosis of many diseases in medicine. Besides its wide application in gene editing, CRISPR technology features a powerful tool for the highly sensitive and selective quantification of nucleic acids. In this talk, the first CRISPR/Cas13a powered electrochemical microfluidic biosensor for on-site miRNA detection will be presented. Without any target amplification, it offers a low-cost, easily scalable, and multiplexed approach for nucleic acid diagnostics.

11:50 KEYNOTE PRESENTATION: Molecular POCT: From Esoteric to Mainstream – From Concept to Production

Anders Wolff, PhD, Professor, Department of Biotechnology and Biomedicine, Technical University of Denmark, DenmarkFar too many point-of-care tests (POCT) developed at

universities are never commercialised. For commercialisation, it is important to consider the choice of materials, fabrication-, bonding-, and detection methods, etc. These should be suitable for mass production, low cost and easy to use and handle. In my group, we have developed different solutions, design and methods that can be produced at a realistic low price and can be scaled up from prototypes to full-scale industrial mass production. Other important issues are assay design and integrated reagents. I will discuss these subjects and include examples from our research.


12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:20 Session Break

WEARABLES AND HOME DIAGNOSTICS13:50 Chairperson’s RemarksVincent Linder, PhD, CEO, Calciscon, Switzerland; Founder and President, CDP BioMedical Consulting, Portugal

14:00 Nanodroplet Microfluidics – A Versatile Tool for Continuous Biomarker Monitoring: Case Study of a Wearable Sensor for Lactate MonitoringOliver Hofmann, PhD, MBA, CEO, SouthWestSensor Limited, United KingdomNanodroplet microfluidics provides a powerful tool for high-frequency, wet chemistry-based measurement of biomarkers. We describe the transition of this versatile approach from lab to point-of-care use. SouthWestSensor Ltd. has developed a wearable sensor solution for measuring lactate, a key marker for instance in the management of sepsis. We demonstrate tracking of lactate levels in dermal tissue with results in close agreement with off-line analysis of peripheral blood samples.

14:30 Development and Clinical Validation of the T50 Test for Accurate Measurement of Phosphate Toxicity, and Its Extension to the Point-of-CareVincent Linder, PhD, CEO, Calciscon, Switzerland; Founder and President, CDP BioMedical Consulting, PortugalCalciscon has developed the T50, a blood test for Phosphate Toxicity, which is the adverse effect that phosphate exerts on cells, tissues and organs, and is associated with numerous pathologies. In this contribution we discuss the foundational work that led to the invention of the T50, its clinical validation across multiple cohorts of patients with chronic kidney diseases (CKD), and the adaptation of the test to deliver clinical value in point-of-care applications.

15:00 Ultra-Fast, Highly Multiplexed Point-of-Care Test for Detection of MSSA/MRSA/PVL within 15 Minutes from a Nasal Swab to ResultsPiotr Garstecki, PhD, President & CTO, Scope Fluidics SA, PolandWe use the PCR|ONE point-of-care molecular diagnostics platform in screening tests detecting MSSA, MRSA and the gene coding the PVL toxin. We describe the technical realization of key stages of the protocol, including automated sample preparation and DNA isolation, microfluidic multiplexing and infrared radiation-mediated ultra-fast PCR reaction, together with the results of validation in clinical environment.

15:30 Biowatch and What Home Dx and Wearable IVD Products Can Do Outside of HealthcareMikkel Thykjær Jørgensen, CEO, Founder & Partner, Biowatch ApS, DenmarkBiowatch gives health-interested users access to professional analysis of biological material, enabling the user to detect and correct imbalances, optimize performance, and proactively engage in the prevention of lifestyle diseases.

16:00 Close of Conference


WEDNESDAY 20 MAY

11:00 Registration


12:35 Session Break

KEYNOTE SESSION: BRINGING LIQUID BIOPSYASSAYS TO THE CLINIC

14:00 Keynote IntroductionAlain R. Thierry, PhD, Director of Research, Biomarkers for

Precision Oncology, IRCM/INSERM, France

14:05 How Can a Network Enable Liquid Biopsy Introduction into the Clinic on a Large Scale?

Klaus Pantel, MD, Professor, Chairman, Institute of Tumor Biology, University Medical Center Hamburg-Eppendorf, GermanyThe analysis of tumor cells (CTCs) and tumor cell products

(DNA, miRNA, extracellular vesicles or tumor-educated platelets) in blood can provide clinically relevant information as “liquid biopsy”. To support the translation into clinical routine, the European Liquid Biopsy Society was recently established based on the achievements of the EU/IMI sponsored consortium CANCER-ID (www.cancer-id.eu). Here, the opportunity of ELBS to transfer liquid biopsy research into clinical practice will be outlined and discussed.

14:35 Donor-Derived Cell-Free DNA Testing in Organ Transplantation: A Value Proposition

Michael Oellerich, MD, Hon MD, FAACC, FAMM, FFPath (RCPI), FRCPath, Distinguished Research Professor, Clinical Pharmacology, University Medical Center Goettingen (UMG), GermanyThere is a need to improve personalized

immunosuppression in organ transplantation to reduce premature graft loss. A value proposition concept was applied for donor-derived cell-free DNA testing in plasma of transplant recipients as an alternative to invasive biopsies to early detect or exclude rejections or other graft injuries. This approach allows to personalize immunosuppression and may improve outcome. Transplant physicians could provide better immunosuppressive guidance. Hospital management and insurance companies benefit from more cost-effective surveillance of transplant recipients.

15:05 Detection of Cell-Free Circulating BRAFV600E by Droplet Digital PCR in Patients with Melanocytic Cutaneous Lesions: Considerations for the Clinical Implementation

Joan Anton Puig-Butille, PhD, Head, Molecular Biology CORE, Hospital Clinic of Barcelona, SpainThe p.V600E mutation in BRAF gene (BRAFV600E) is

frequently detected in melanoma and common benign naevi. We evaluated the clinical significance of detection of

BRAFV600E in plasma cfDNA (cfBRAFV600E) from melanoma patients and from patients without melanoma undergoing regular follow-up of their melanocytic lesions. The study suggests that naevus-related factors do not influence the detection of cfBRAFV600E and supports the clinical diagnostic value of cfBRAFV600E quantification in melanoma patients.



MULTI-OMIC APPROACHES17:00 Chairperson’s RemarksDaniel Wetterskog, PhD, Senior Research Associate, UCL Cancer Institute, University College London, United Kingdom

17:05 Sample to Answer Multi-Omic Exosome and cf-DNA Biomarker Detection for Liquid Biopsy DiagnosticsMichael Heller, PhD, Professor and Distinguished Scientist, Center for Cancer Early Detection and Research (CEDAR), Knight Cancer Institute, Oregon Health & Science University (OHSU), United StatesNew multi-omic approaches for combining genomic and proteomic biomarker information are becoming a viable strategy for liquid biopsy diagnostics. Electrokinetic samples to answer ACE microarray chip devices now allow rapid isolation of exosomes/EV biomarkers, cell free (cf) DNA and RNA from small volumes of cancer patient blood samples. On-chip fluorescent detection of cf-DNA levels, immunostaining for specific exosome/EV protein biomarkers and subsequent sequencing analysis for point mutation biomarkers were successfully carried out on blinded patient samples for pancreatic cancer diagnostics.

17:35 Clinical Application of Ultrasensitive Sequencing of Cell-Free Tumor DNA and Immune CellsAnders Ståhlberg, Associate Professor, Sahlgrenska Cancer Center, University of Gothenburg; Clinical Genetics & Genomics, Sahlgrenska University Hospital, SwedenDetailed analysis of cell-free tumor DNA and immune-cell clonality in liquid biopsies requires ultrasensitive sequencing. We have developed simple, flexible and sensitive approaches to analyze DNA from various cell sources, as well as from circulating cell-free DNA. Here, we will present our experiences of using ultrasensitive analysis from both a clinical and technical point of view. Data from different applications will be shown.

18:05 A Multi-Omic Strategy for Cancer Diagnostics and MonitoringMichael Roehrl, MD, PhD, Associate Professor of Pathology and Laboratory Medicine, Pathology and Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, United StatesAn integrated approach to cancer that encompasses combining genomics, transcriptomics, and epigenomics with deep proteomics promises to become a powerful tool for cancer diagnosis, personalized treatment guidance, resistance detection, and recurrence monitoring. We will discuss several examples using such combined approaches (including gastrointestinal cancers and sarcomas), new technological and specimen-directed advances for correlating circulating and tissue-resident cancer markers, and the computational challenges that arise from multi-omic big data analytics.

18:35 Close of Day

THURSDAY 21 MAY

EXAMINING CIRCULATING TUMOUR CELLS08:30 Registration and Morning Coffee

09:00 Chairperson’s RemarksCatherine Alix-Panabieres, PhD, Director, Laboratory of Rare Human Cells (LCCRH), Department of Pathology and Onco-Biology, University Medical Centre of Montpellier, France


Enabling Technologies for Liquid Biopsy and Beyond - Part IIDeveloping Novel Assays for Circulating Biomarkers and Clinical Use



http://www.cancer-id.eu


Enabling Technologies for Liquid Biopsy and Beyond - Part II

09:05 Detection, Characterization and ex vivo Expansion of Viable Circulating Tumor Cells (CTCs)Catherine Alix-Panabieres, PhD, Director, Laboratory of Rare Human Cells (LCCRH), Department of Pathology and Onco-Biology, University Medical Centre of Montpellier, FranceCirculating tumor cells (CTCs) in blood are promising new biomarkers potentially useful for prognostic prediction and monitoring of therapies in patients with solid tumors including colon cancer. Moreover, CTC research opens a new avenue for understanding the biology of metastasis in cancer patients. The establishment of cell cultures and permanent cell lines from CTCs has become the most challenging task over the past year.

09:25 Capture of Circulating Tumour Cell Clusters Using Straight Microfluidic ChipsChamindie Punyadeera, PhD, Associate Professor, Biomedical Sciences, Queensland University of Technology, AustraliaWe have demonstrated that CTCs can be isolated from head and neck cancer (HNC) patients before clinically evident metastasis, using a novel, spiral microfluidic technology and now we have exciting preliminary data correlating CTC presence to clinical outcomes during the course of treatment. Using the state of the art technology, straight channel microfluidic technology, we have been able to detect CTC clusters from HNC, non-small cell lung cancer and glioblastoma. These clusters contain two or more CTCs and leukocytes and were found in advanced stage cancer patients. This microfluidic technology has the ability to transform scientific findings into translational outcomes and tangible health benefits with a significant reduction in healthcare costs.

09:45 Patient-Derived Circulating Tumor Cells as a Predictor of Treatment Response and SurvivalPrashant Kumar, PhD, Faculty Scientist, Cancer Biology, Institute of Bioinformatics, IndiaMonitoring CTCs is a valuable strategy for guiding patient treatment, predicting cancer progression, and evaluating the risk for metastatic relapse. We have devised a microwell-based culture method to assess CTCs from patients undergoing neoadjuvant therapy. The culture method allowed selective enrichment of CTCs that went on to form proliferative clusters. Cluster formation was affected by the presence and duration of systemic therapy and its persistence may reflect therapeutic resistance.


10:35 Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing

MUTATIONAL ANALYSIS11:20 Mutational Analysis of Circulating Tumor Cells at the Single-Cell LevelPamela Pinzani, PhD, Associate Professor, Clinical, Experimental and Biomedical Sciences, University of Florence, Italy

11:50 CO-PRESENTATION: Molecular Tagging NGS Technology in Liquid Biopsy: Mutational Profiling of ctDNA and CTCsMaria Dono, PhD, Senior Researcher, Pathology, Molecular Diagnostics, IRCCS Ospedale Policlinico San Martino, ItalyGiuseppa De Luca, PhD, Postdoc Research Fellow, Pathology, Molecular Diagnostic, IRCCS Ospedale Policlinico San Martino, ItalyMolecular analysis of liquid biopsy biomarkers, resembled primarily by circulating tumor DNA and cells (CTCs) is technically challenging. The development of NGS panels, molecular tagging-based, gives a relevant chance for their accurate molecular characterization. Here, we will discuss some data developed by using commercial NGS assays for the study of ctDNA in NSCLC patients and CTCs isolated from breast cancer patients.


12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

13:20 Session Break

EXOSOMES AND DNA METHYLATION13:50 Chairperson’s RemarksChrista Noehammer, PhD, Senior Scientist, Molecular Diagnostics, AIT Austrian Institute of Technology GmbH, Austria

14:00 An Exosome-Based Liquid Biopsy for Detection of Melanoma Residual DiseaseSusana García-Silva, PhD, Senior Researcher, Oncology Program, Spanish National Cancer Research Centre (CNIO), SpainTumor-derived, extracellular vesicles carry a portrait of the cancer cells and associated microenvironment. Our data show that extracellular vesicles isolated from the lymphatic exudate of melanoma patients can be interrogated for melanoma markers and BRAF mutations. Profiling the BRAFV600 mutation in lymph-circulating EVs is a novel prognostic approach to predict residual disease after tumor resection and lymphadenectomy.

14:30 A Liquid Biopsy PCR Assay to Detect Cell-Free DNA from Dying Neurons and GliaJason Ross, PhD, Principal Research Scientist, Health and Biosecurity, CSIRO, AustraliaIn head trauma, DNA from dying brain cells is released into peripheral blood. Using the DNA methylation marks present on this brain cell-free DNA (cfDNA), it is possible to discretely identify brain cfDNA against the usual blood background. Applying this principle, we have developed a PCR diagnostic assay which can specifically detect small quantities of cfDNA from dying neurons and glia. Recently, we have commenced clinical trials.


15:30 Rapid Nickel-Based Isolation of Extracellular Vesicles for Multidimensional Liquid Biopsy TestsVito Giuseppe D’Agostino, PhD, Group Leader, Laboratory of Biotechnology and Nanomedicine, CIBIO, University of Trento, ItalyExtracellular vesicles (EVs) are membranous structures massively released in biofluids. EVs carry cellular components, such as lipids, proteins, and nucleic acids, that can work as a formidable source in liquid biopsy studies. We recently described the nickel-based isolation (NBI) as a versatile method for fast and efficient recovery of heterogeneous EVs. We combined NBI with RNA- , as well as protein-based ultrasensitive technologies, improving the detection of biomarkers under clinical use.

16:00 Pan-Genome cfDNA Methylation Analysis of Metastatic Prostate CancerAnjui Wu, PhD, MD, Postdoctoral Research Fellow, UCL Cancer Institute, University College London, United KingdomGenomic profiling of cfDNA has been well described in multiple tumour types, including lung cancer, colon cancer and prostate cancer; however, the cfDNA methylation status has not been extensively studied. I will present our unpublished work on cfDNA methylation analysis of metastatic prostate cancer, and our data indicated that plasma methylome has great potentials for cancer screening, detection and risk stratification.

16:30 Close of Conference

19-21 May 2020 | 8th Annual Diagnostics

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Transcript of 19-21 May 2020 | 8th Annual Diagnostics