Swiss Symposium in POC 2017 - hevs.ch

HES-SO Valais-Wallis • rte du Rawil 64 • c.p. 2134 • 1950 Sion 2 +41 27 606 86 11 • [email protected] • www.hevs.ch/itv

Thematic Platform IVD

National Thematic Network

26 OCTOBER 2017 SWISS SYMPOSIUM INPOINT- OF- CARE DIAGNOSTICS

WELCOME Dear symposium attendees, on behalf of the HES-SO Valais-Wallis, CSEM, SBC, The Ark foundation and the NTN Swiss Biotech™ thematic platform in-vitro Diagnostics (TP IVD) we would like to welcome you to the Swiss Symposium in Point-of-Care Diagnostics. We have invited expert speakers who are going to highlight our main topic from different angles. Each of today’s three sessions will be kicked-off by presentations giving the medical and clinical context. Then, the applied research point of view will be illustrated with technological advancements that may set the stage for future innovations. Finally, each session will close with case examples of successfully developed POC diagnostic products. During lunch break, you are invited to visit the exhibition stands, where established companies show their POC diagnostic products, research institutions have prototypes on display while start-ups present their smart concepts. Lastly, do not miss out on the poster exhibition with contributions also from young scientists. The symposium day will conclude with the keynote speech by Prof. George M. Whitesides from Harvard University (USA): “Accessible Bioanalysis for the Developing World and the Point of Care”. Wishing you all an exciting and informative day with many stimulating discussions. Sincerely yours, Prof. Dr. Marc E. Pfeifer Dr. Dieter Ulrich Chairman Co-Chairman HES-SO Valais CSEM Landquart

S w i s s S y m p o s i u m i n P O C D i a g n o s t i c s

ORGANISERS HES-SO Valais Wallis Institute of Life Technologies, Research Group “Diagnostic systems”

CSEM

SBC Swiss Biotech Center The Ark

Swiss Biotech Thematic Platform IVD


ORGANISING COMMITTEE Prof. Marc E. Pfeifer, Chairman Tel +41 27 606 86 61 HES-SO Valais [email protected] Dr. Dieter Ulrich, Co-Chairman Tel +41 81 307 81 12 CSEM Landquart [email protected] Dr. Massimo Nobile Tel +41 27 606 88 71 The Ark Foundation [email protected] Denis Prim Tel +41 27 606 86 40 HES-SO Valais [email protected] Prof. Bruno Schnyder Tel +41 27 606 86 59 HES-SO Valais [email protected] Prof. Jean-Manuel Segura Tel +41 27 606 86 68 HES-SO Valais [email protected] Claudia Silvany Vogt Tel +41 81 307 81 11 CSEM [email protected] Alexia Crettenand Tel +41 27 606 86 77 HES-SO Valais [email protected]


PROGRAMME 09h00 ...... Registration & Coffee 10h00 ...... Welcome Note Gaëtan Cherix – Director, School of Engineering Marc E. Pfeifer – Symposium Chair MORNING SESSION – DIETER ULRICH, CSEM 10h15 ...... Nicolas Senn – PMU, UNIL Point-of-care Diagnostics: what are the real needs of general practioners? 10h40 ...... Philippe Renaud – EPFL Recent developments in microtechnologies for point-of-care testing 11h05 ...... Patrice Allibert – GenePOC GenePoc, a breakthrough solution in molecular point-of-care testing 11h30 ...... Jakob Weber – BÜHLMANN Laboratories mHealth in the therapy follow-up of chronic inflammatory diseases – a smartphone based self-

monitoring tool 11h55 ...... Lunch Break Product Exhibition and Posters session 1ST AFTERNOON SESSION – ALEXANDER LEICHTLE, INSELSPITAL 13h40 ...... Franziska Amiet – Inselspital Successful integration of POCT in hospitals: requirements and challenges 14h05 ...... Michèle A. Fleury-Siegenthaler – Federal Office of Public Health Reglementary aspects ruling the reimbursement of laboratory analyses in the context of the

compulsory health insurance 14h30 ...... Jean-Manuel Segura – HES-SO Valais The applied research programme "Diagnostic Biochips": novel technologies for point-of-care

diagnostics 14h55 ...... Coffee Break 2ND AFTERNOON SESSION – MASSIMO NOBILE, THE ARK FOUNDATION 15h15 ...... Jean-Charles Sanchez – CMU, UNIGE From brain proteomics discovery to the use of a POCT: The translation to mild traumatic brain injury

(mTBI) 15h40 ...... Samantha Paoletti – CSEM Recent advances in non-invasive diagnostics 16h05 ...... Fabien Rebeaud – Abionic How nanofluidics bring diagnostics closer to the patient 16h30 ...... Refreshment KEYNOTE SESSION – MARC E. PFEIFER, HES-SO VALAIS 16h45 ...... George M. Whitesides – Harvard University, Cambridge – USA Accessible bioanalysis for the developing world and the Point of Care. 17h45 ...... Closing Words 18h00 ...... Apero


SPONSORS & EXHIBITORS

La manifestation est sponsorisée par Siemens Healthcare Diagnostics Sàrl

BioAlps, the Life Sciences Cluster of Western Switzerland

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We develop exchange between Scientific, Economic and Political Communities

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We increase visibility of the members regionally, nationally and internationally

«BioAlps, the most diversified Life Sciences Cluster in the World!»

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Unique network that supports the competitiveness of the Biotech Ecosystem – fueled by close ties between

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Biotechnet: areas of strategic focus

Combining core competences of companies and academia Bringing together top expertise across SwitzerlandSupporting biotech education in SwitzerlandConcentrating knowledge and technology around defined platforms

Helping build up alliances for innovative projects and productsEnabling access to a reliable network of know-how and infrastructureIntensifying research-related communication by means of focused events

Thematic Platforms

TissueEngineering

for Drug Discovery

Translational andClinical Bio-

Manufacturing

In Vitro Diagnostics

Bioinformatics

Antibiotics

Biologics

BioresourceTechnologies

Single-Use-Technology

Biocatalysisand

Biosynthesis

Training forPharma/Biotech


Thematic platform “In-Vitro Diagnostics” (IVD)

Mission

The thematic platform in-vitro diagnostics (TP IVD) promotes ttechnological innovation in the area of in-vitro diagnostics by providing access to a nnetwork of experts. This new national collaborative platform also supports project ideas by providing sseed money. The TP IVD further enables the translational research by organizing eevents and company visits. The offer of the platform is further strengthened by national and international collaborations with other networks and organizations.

The TP IVD unites key stakeholders from iindustry, mmedicine and rresearch organizations to combine excellent skill sets ranging from molecular biology, biochemistry, micro-/nanotechnology and bio-analytics, miniaturization, automation, data management as well as to regulatory affairs and health economics.

Platform organisation

The platform is co-lead by Dr. Dieter Ulrich (CSEM SA) and Prof. Dr. Marc E. Pfeifer (HES-SO Valais).

The SSteering Committee is composed of the following members of the industry and research and technology institutions:

Dr. Dieter Ulrich, CSEM SA / Prof. Dr. Marc Pfeifer, HES-SO Valais / Prof. Dr. Eric Kübler, FHNW / Dr. Alexander Leichtle, Universitätsinstitut für Klinische Chemie, Inselspital / Prof. Dr. Bruno Schnyder, HES-SO Valais / Dr. Jakob Weber, BÜHLMANN Laboratories AG The AAdvisory Board consists of experts in the diagnostics field and supports the Steering Committee with strategic recommendations:

Dr. Gesa Albert, Roche Diagnostics AG / Prof. Dr. Peter Meier-Abt, President of the SAMW, former Vice President of the University Basel / Prof. Dr. Olaia Naveiras, EPFL / Dr. Manfred Schawaller, Davos Diagnostics AG / Dr. Thomas Stauffer, Medics Labor AG

POC Test Systems offered by BÜHLMANN Laboratories AG

BÜHLMANN Laboratories AG Tel. + 41 61 487 12 12 Baselstrasse 55 Fax + 41 61 487 12 34CH - 4124 Schönenbuch [email protected] www.buhlmannlabs.ch

COMING SOON Pharyngeal Strep

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CSEM SA ∙ Rue Jaquet-Droz 1

2002 Neuchâtel ∙ Suisse

Alpnach ∙ Landquart ∙ Muttenz ∙ Neuchâtel ∙ Zurich

Tél. +41 32 720 5111

[email protected] ∙ www.csem.ch


La HES-SO Haute école spécialisée de Suisse occidentale qui compte plus de 21’000 étudiantes et étudiants, est la plus grande HES de Suisse.

Ses 68 filières d'étude Bachelor et Master ainsi que ses recherches se déclinent dans six domaines qui sont Ingénierie et Architecture, Design et Arts visuels, Economie et Services, Musique et Arts de la scène, Santé et Travail social.

Fondée en 1997, la HES-SO forme un ensemble interdisciplinaire, riche et performant aussi bien sur le plan de l’enseignement qu’en matière de Recherche appliquée et Développement. Celle-ci est orientée vers la pratique et menée en partenariat avec des entreprises, des institutions socio-sanitaires et culturelles enracinées dans les différentes régions de Suisse romande. Avec son vaste réseau de hautes écoles, la HES-SO joue un rôle prépondérant dans le développement socio-économique, socio- sanitaire et culturel dans les sept cantons de la Suisse occidentale. Elle se positionne également comme une actrice reconnue du paysage suisse et international de l’enseignement supérieur.

La recherche appliquée est au cœur des missions de la HES-SO. Menée par des chercheurs disposant de compétences académiques et ancrées dans la pratique, elle permet de répondre aux défis posés par la société et l’économie. De plus, les résultats reviennent dans les enseignements dispensés aux étudiants.

Depuis quatre ans, le Domaine Ingénierie et Architecture a structuré ses projets de recherche appliquée en six programmes thématiques qui, ensemble, couvrent tous les champs d’étude du domaine. De l’énergie à l’optimisation de la chaîne agroalimentaire, en passant par l’étude de la densification urbaine ou des objets connectés, ces programmes thématiques ont pour objectif de trouver des solutions concrètes aux problèmes de notre temps.

Le programme thématique Diagnostic Biochips propose des solutions d’analyses rapides et proches des patients. Il est réalisé en étroite collaboration avec des acteurs directs du monde de la santé et offre une vitrine des compétences développées au sein des hautes écoles de la HES-SO.

INSTITUTE OF LIFE TECHNOLOGIESDiagnostic SystemsResearch Group

The Diagnostic Systems group consolidates in-depth theoretical and practical know-how ranging from areas such as immuno-, molecular and cellular diagnostics to instrumental analytics and bio-sensor development, including compound and phyto extract activity screening. Together with the Institute of Systems Engineering and the Institute of Information Systems, our research group conceptualizes, designs and develops innovative automation and miniaturization solutions to bio-analytical challenges.

RESEARCH AREAS

Point-of-care (POC) diagnostics• Point-of-care (POC) diagnostics and lab-on-a-chip devices

• Miniaturized, portable or wearable sensor systems

• Efficient sampling and functionality integration

• Sophisticated capture molecules and detection systems

• Remote access and data management

Cellular systems• Bioavailability (e.g. intestinal transport)

• Bioactivity (e.g. anti-inflammatory, anti-infectious)

• Biocompatibility (e.g. biopolymers)

• 3D models (e.g. cell-scaffold interactions)

• Microfluidics (e.g. cellular analytics)

Molecular diagnostics• PCR or other amplification/detection methods

• Gene expression and epigenetics

• Pathogen identification and typing

• Immunoassays (e.g. fluorescence, ECL-based)

• Multivariate, multiplex (e.g. microarrays, DNA-chips)

Phyto-actives• Skin therapeutics (e.g. inflammation, infections)

• Reliable cellular assays

• Active ingredient transport

• Cosmetic (and pharma) market

• Pilot scale facilities at PhytoArk

SENIOR RESEARCHERSAlain-François Grogg, PhD Chemistry, Phytochemistry, Bioactivity screening

Jean-Manuel Segura, PhD POC diagnostics, Assay development, Detection systems

Marc E. Pfeifer, PhD In-vitro diagnostics (IVD), Molecular diagnostics, POC diagnostics

Bruno Schnyder, PhD Biochemistry, Immunology, Cellular systems

CONTACT PERSON Marc Pfeifer, PhD

University of Applied Sciences and Arts Western Switzerland Valais Institute of Life Technologies

Route du Rawyl 64 – CH–1950 Sion 2T +41 27 606 86 11 • T +41 27 606 86 61 (direct) • F +41 27 606 86 15

E [email protected] • http://itv.hevs.ch

www.hevs.ch/htic

siemens.com/poc-informatics

AlwaysOpen

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Point-of-care Diagnostics: what are the real needs of general practitioners ?

Nicolas Senn Policlinique Médicale Universitaire, Institut universitaire de médecine de famille, Lausanne, Switzerland During this presentation, we will describe the main features of the primary care setting in terms of epidemiology, functioning of GP practices and main constraints. This will serve to define the needs for POC for GPs. In brief, GP’s are working in low prevalence setting. Thus, most diseases are in fact rarely encountered. Furthermore, time with patients is limited. Lastly, the variety of possible diagnosis seen in clinical practice is large. In such context, it is more useful to have tests able to exclude diseases with good negative predicative values and to have tests that take little time to perform with long expiry dates. POC should also focus mostly on diseases for which a quick medical decision is needed (admit the patient,…). In a second part of the presentation, we will provide an example of malaria POC rapid tests assessment that illustrates the outcomes of interest in primary care. Indeed, even though imperfect, these tests proved to have a very good effectiveness and safety when used in routine care.


Recent developments in microtechnologies for point-of-care testing

Philippe Renaud Microsystems Laboratory, EPFL, Lausanne, Switzerland Point-of-care (POC) devices and instruments require robust and reliable measurement clinically relevant biomarkers with a minimal handling steps and lightest invasiveness for the patient. Miniaturization technologies had a large impact on development on POC devices because of its capacity of handling very small sample and integrating multiple processing or measurement modalities in a compact system. Despite the strong development of microfluidic and sensor technologies, the validation into commercial applications is not as easy as expected. The complexity of integrating all functions into one microsystem makes difficult to reach the needed reliability, accuracy and cost compatible with market requirements. This is why the most successful new POC devices are mostly based on a smart use of simple technologies. We will discuss some challenges and new technologies that are related the access of biomarkers and to sample preparation in non-ideal matrix.


A breakthrough solution in Molecular POC testing

Patrice Allibert GenePOC, Quebec, Canada The need to simplify processes and accelerate molecular testing at lower costs is revolutionizing MDx, spurring innovation in this space. Advanced PCR methods along with emerging disruptive technologies based on microfluidics are driving low-cost, “sample-to-result,” miniaturized device development, providing ground-breaking platforms for applications in infectious disease point-of-care testing (POCT).

Anticipating this medical need, GenePOC developed the revogene: a compact, fully automated and, stand-alone instrument that is well suited for on the spot molecular diagnostic testing. It uses real-time Polymerase Chain Reaction (PCR) technology and offers unique flexibility, allowing the labs to run from 1 to 8 samples simultaneously, for an optimal testing workflow.

Today, GenePOC launched two CE-IVD assays into the market: GenePOC CDiff for the detection of toxigenic C. difficile DNA in liquid or soft stool specimens and the GenePOC GBS DS for the screening of Group B Streptococcus directly from vaginal/rectal swab at intrapartum. Both assays showed very good performances when tested by several labs and hospitals across Europe.

GenePOC will continue its menu expansion to address the main challenges of infectious disease testing and bring the best solution to healthcare professionals and patients.


mHealth in the therapy follow-up of chronic inflammatory diseases – a smartphone based self-monitoring tool

Jakob Weber Bühlmann Laboratories, Schönenbuch, Switzerland There is a big impact of immune-mediated inflammatory disease on patients suffering of such chronic disabling conditions in terms of physical suffering and pain leading to diminished quality of life and work-related productivity. Regular testing of inflammatory biomarkers such as calprotectin or C-reactive protein in patient’s stool extracts (i.e. inflammatory bowel disease) or serum (i.e. rheumatoid arthritis) increases the need for rapid tests that can be performed by the patients themselves.

We have developed a smartphone based home testing platform, called IBDoc®, that allows real-time information about the inflammatory activities in the gut for both, the patient and the clinician. The IBDoc® consists of a stool collection and extraction device and an immunochromatographic calprotectin rapid test, which is measured using a smartphone app controlling the phone’s camera. Once the test is measured the result is sent to a secured webserver allowing the treating physician immediate access to the result. IBDoc® is the first such test system to have achieved the CE-IVD mark for self-testing in March 2015 by a notified body. The expansion and application of this platform to other medical and therapeutic fields will be discussed.


Successful integration of POCT in hospitals: requirements and challenges

Franziska Amiet Inselspital, Bern, Switzerland The choice for POCT depends on many factors. In hospitals, it must fit in the very busy and challenging daily work. It should be easy to handle, safe, cheap, give comparable results with the laboratory devices and be connectable to established IT-systems. Results should be rapidly available without media break and be shown together with all other important patient related data on the patient data monitoring system. Then, POCT can be the missing piece in the puzzle and brings key benefits to all involved parties.


Reglementary aspects ruling the reimbursement of laboratory analyses in the context of the compulsory health insurance

Michèle Fleury-Siegenthaler, Karin Schatzmann, Stefan Otto Federal Office of Public Health (FOPH), Bern, Switzerland The compulsory health insurance (CHI) covers the costs of medical care needed to diagnose or treat a disease and its consequences (art. 25, Health Insurance Law [HIL]).

It also covers the costs of tests aimed to detect diseases in time and preventive measures for threatened insured (art. 26, HIL), if listed in art. 12d and 12e, Ordonnance sur les prestations de l’assurance des soins.

Health care coverage is based on closed and open lists of health technologies (HT). The procedure of addition/retrieval of HT is based on requests to the FOPH by who may be concerned. To be covered by the CHI, HT have to fulfil the effectiveness, appropriateness and economic efficiency criteria (art. 32, al. 1, HIL). Decisions for coverage are taken by the federal department of house affairs (FDHA), or the FOPH for drugs, based on the recommendations of advisory stakeholder commissions.

Analyses can only be covered by the CHI, if they are made in medical laboratories according to art. 53 and 54, Ordonnance sur l’assurance-maladie.

The FDHA edicts a list of analyses with rate (art. 52, HIL). The rate, applicable for ambulatory care, is the maximal admitted rate. Per analogy invoicing is not allowed.

A diagnostic test has to allow to decide, if a treatment is needed, to reorientate the medical treatment, to redefine the tests needed or to give up other tests. Analyses, for which it is clear at the moment of ordering, that they will not correspond to one of these four criteria, will not be reimbursed.


The applied research program «Diagnostic Biochips»: Novel technologies for POC diagnostics

Jean-Manuel Segura Institute of Life Technologies, University of Applied Sciences and Arts Western Switzerland Valais, Sion, Switzerland “Diagnostic Biochips” is an applied research program of the HES-SO with the objective of developing novel enabling technologies for point-of-care diagnostics. Projects aim at the realisation of demonstrators of new medical devices such as a portable multiplex POC analyser, a portable skin analyser, a hydration monitoring system and a pressure sensor for hydrocephaly treatment. These interdisciplinary projects are performed in close collaboration with medical and industrial partners.

As an example, I will describe the results of a project aiming at the development of a drug monitoring system. Therapeutic Drug Monitoring (TDM) allows for personalized dosage during therapeutic treatments and is often mandatory for modern potent drugs against cancer, infections or in organ transplantation cases. Currently, the process of TDM is demanding for the patient as several milliliters of blood are required, is slow and costly and suffers of limited efficacy owing to the difficulty to interpret the results for a non-specialist.

In a first project, we aimed at circumventing these problems by developing a point-of-care device enabling the quantification of therapeutic drugs in blood using fluorescence-polarization immunoassays (FPIA). We showed that FPIA can be downsized with reduced requirements in blood sample (only 1 μL) and number of steps, without compromising assay reliability, and can be successfully integrated within paper-like micro-chambers. Whole-blood measurements were made possible by further using the paper-like micro-chambers as a filtering device. The final TDM point-of-care test requires minute amounts of blood and minimal handling steps (see Figure).

In a second project, we addressed cases where single measurements are not sufficient like during cancer chemotherapies. Here patients are subjects to administration of high doses of drugs during long periods of time which can last up to several days. Ideally, drug doses should be continuously adjusted to keep blood concentrations within the therapeutic range. This requires regular blood tests, typically every 15 to 30 minutes. I will present the latest results of a project aiming to develop an autonomous monitoring system able to continuously measure drug concentrations in blood.


Combining IL-10 and H-FABP increases the capacity to differentiate between CT-positive and CT-negative patients with mild traumatic brain injury

Linnéa Lagerstedt1, Jean-Charles Sanchez1* 1Department of Human Protein Sciences, Faculty of Medicine, University of Geneva, Geneva, Switzerland Mild traumatic brain injury (mTBI) patients may have trauma-induced brain lesions. CT scans are used to identify those at risk of developing brain lesions, but most will be CT-negative. A better means of detecting patients at risk is needed. Single blood biomarkers in mTBI patients have been widely studied as CT decision tools, such S100B and GFAP. To date, however, none seems to have performed well enough. Combining several biomarkers into diagnostic panels which enhance classification performance has raised increasing interest in many different diseases. We evaluated 15 proteins – S100B, H-FABP, MMP-1, MMP-3, MMP-9, CCL-23, VCAM, ICAM, SAA, CRP, GSTP, NKDA, PRDX1, DJ-1 and IL-10 – individually and in combination, for their capacity to differentiate between patients with and without a brain lesion according to CT results. Three different European sites enrolled cohorts of patients diagnosed with mTBI, a GCS of 15 and one additional clinical symptom. Each patient gave a blood sample at hospital admission and underwent a CT scan. Patients were dichotomised into CT-positive and CT-negative groups for statistical analysis. Single markers and panels were first evaluated for the whole cohort, with sensitivity set at 100%. Three proteins – H-FABP, IL-10 and S100B – were present at significantly higher levels in CT-positive patients. At 100% sensitivity, the best-performing single marker was H-FABP, reaching 35% specificity (95% CI 25.9–43.8); the best-performing two-marker panel, validated on two independent cohorts, combined H-FABP and IL-10. At 100% sensitivity, their combination improved specificity to 45% (95% CI 36–55). At 100% sensitivity, adding S100B and age to this panel boosted performance to 64% specificity (95% CI 55–73).


Recent advances in non-invasive diagnostics

Paoletti Samantha CSEM, Landquart, Switzerland Today, most routine health assessment techniques rely on blood based analysis, involving invasive sample collection and time-consuming sample preparation and analysis protocols. Over the last decade there has been a shift towards the use of “freely accessible” body fluids like saliva, tears, urine, breath and sweat. However, the technologies employed to collect, prepare and analyse these samples are not yet sufficiently accurate, robust and easy to use. Furthermore, there is a poor evidence base on the validity of the results obtained from these fluids.

At CSEM development of different sensors and solutions for non-invasive monitoring is ongoing since several years, with the aim to provide simple and robust solutions for health assessment, non-invasive point of care diagnostics and therapy monitoring devices.

Different solutions for diagnostics have been developed based on a modular approach, including:

a. Sample collection and preparation: based on different microfluidics designs, that allow to collect, sample, load and process different body fluids as urine, saliva and sweat. Simple pre-concentration approaches have been successfully tested.

b. Detection unit: according to specific targets and requirements, CSEM developed colorimetric, fluorescent or electrochemical sensors that are integrated in cost-effective systems.

c. Data acquisition, analysis and exchange: together with the detection unit, CSEM is working also on the necessary electronics, power management and data management tools to realize a full integrated system.

CSEM has proved that the sensors could be integrated in wearable solutions (sweat analysis) or be used for saliva and urine diagnostics.

An important focus in our work is the usability of the new device by untrained personnel, in clinically challenging situations and in remote areas.


How nanofluidics bring diagnostics closer to the patient

Fabien Rebeaux Abionic, Epalinges, Switzerland Advances in physical, material and chemical sciences as well as micro- and nanofabrication technologies has brought nanotechnology to play an important role in numerous biomedical applications, including in vitro diagnostics (IVD). Abionic developed the abioSCOPE®, an innovative point-of-care platform based on nanofluidic biosensors assembled into disposable cartridges. Nanofluidic channels strongly influence the diffusional behavior of biomolecules and increase molecular interactions. In addition, due to the high surface to volume ratio, the interaction of biomolecules with the surfaces is strongly enhanced and therefore nanofluidic systems provide excellent ways to improve performances of IVD.

To illustrate the potential of nanofluidics, we present here the development and performances of a abioSCOPE® test based on the pancreatic stone protein (PSP), a novel biomarker that aid in the early identification and clinical management of sepsis patients. As biomarkers currently available in clinical laboratories for sepsis diagnosis are neither sufficiently specific nor sensitive, and turnaround times of these tests not suitable is most emergency situations, the development of a PSP test at the point-of-care represents a logical approach. While the combination of PSP and nanofluidics will hopefully substantially improve the way sepsis is diagnosed and treated, bringing a novel technology in hospital settings is not devoid of challenges and hurdles.


Accessible Bioanalysis for the Developing World and the Point of Care

Prof. Georges M. Whitesides Harvard University, Cambridge, United States of America This talk will describe bioanalytical/medical methods designed for use in resource-limited environments, for public health, at the point of care, and in related applications in food and water safe, forensics, and others.

These methods include paper diagnostics, density-based methods (magnetic levitation and two-phase polymer systems), electrochemistry, and cell-phone based methods. The program also asks what strategies in academic research will be most successful in translating results from university bench science into real solutions to problems in health in the hands of users, and who else must be involved in this translation.

Facts about Traumatic Brain Injury• Traumatic brain injury (TBI), according to the WHO, will

surpass many diseases as a major cause of death and di-

sability by the year 2020.

• TBI is the leading cause of death and disability in young

adults. The incidence in elderly patients is increasing.

• In younger patients, Road Traffic Accidents are the most

frequent cause of injury; in older patients, falls.

• Sports, army and juveniles are vulnerable collectives.

ABCDx Solutions For mTBI diagnosis• ABCDx has identified H-FABP alone or in combination

with other known biomarkers with higher performance

enabling better discrimination and for the first time, more

than 50% of presenting patients can be ruled out for brain

injury with a simple blood test, which could be carried out

in virtually any location.

• Within the small proportion of patients with brain injury,

ABCDx’s marker panel also has the ability to identify pa-

tients at risk of severe long-term complications, thus ena-

bling some triage ability for urgent cases.

• ABCDx offers the ability to both substantially reduce the

cost of mild head trauma diagnosis, and at the same time,

improve patient care.

Intellectual Property statusABCDx secured exclusive commercial rights to families

of patent applications protecting the use of multiple-pa-

rametric tests for patients presenting with symptoms of

head injury.

This IP places ABCDx as a leading company offering new

approaches to assessing clinical decisions and rapidly

selecting therapeutic intervention, even in decentralised

locations.

Markers and their use in Brain Injury (WO2016/055148)

Company overview & Licensing opportunity• ABCDx is a company dedicated to transforming brain injury

care by the use of biomarker panel tests for the assess-

ment and indication in patients suffering from mild trau-

matic injury to stroke and post-stroke complications.

• ABCDx has established multi-parametric biomarker pa-

nels, which have the potential to transform the monitoring

of patients, offering more rapid and specific decision ma-

king diagnosis to a much wider range of health care sites,

including point-of-care.

• ABCDx is positioned to grant market exclusivity in a num-

ber of important segments, positioning the company as an

IP and collaboration source of choice for both diagnostic

system manufacturers and therapy providers.

For more information or any enquiry; www.abcdx.ch - [email protected] Office: c/o The Business Harbour, 29, Quai du Mont Blanc, 1201 Geneva, Switzerland - Copyright@2017. All rights reserved.

Current situation on mild TBIIn particular, mild traumatic brain injury (mTBI) is res-

ponsible for high health costs. In contrast to severe TBI,

mTBI is not obvious to detect. Current practice for patients

presenting with mild head trauma is to perform CT scan

where available, to determine presence of brain lesions.

However, CT scan is expensive, can only be carried out in

appropriately equipped facilities and carries some risk to

the patient. Generally, only a small proportion (6-8%) of

patients will have confirmation of a brain injury requiring

hospital stay.

The use of a simple blood test to rule out absence of brain

injury could render 50%+ of these CT scan unnecessary

and be very cost effective to healthcare systems as well as

reducing stress and inconvenience to patients and relieving

burden on over-stressed emergency departments.

Different blood biomarkers such as S100b, Tau, UCHL1

and GFAP have been postulated to enable definitive blood

biomarker testing in mTBI. S100b was commercialized but

failed to win regulatory approval for the indication with its

ability to only rule out 25% of “negative” CT patients.

Blood-based Biomarker test for mild Traumatic Brain Injury stratificationA new method for ruling out mild traumatic brain injury in patients without imaging and enabling rapid discharge

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[Poster 1]

Towards a rapid and quantitative point-of-care test for the differential diagnosis of fever

E. Condemi1, C. Tematio3, N. Fosso3, K. Nicolet2, L. Jeandupeux2, A. Homsy2, S. Schintke3, and J.-M. Segura1

1Institute of Life Technologies, University of Applied Sciences and Arts Western Switzerland Valais (HES-SO), CH-1950 Sion, Switzerland; 2Haute Ecole Arc Ingénierie, HES-SO University of Applied Sciences Western Switzerland, CH-2300 La Chaux-de-Fonds,

Switzerland; 3Laboratory of Applied NanoSciences (COMATEC-LANS), Departement of Industrial Technologies, HEIG-VD - School of Engineering and Management Vaud,

University of Applied Sciences and Arts Western Switzerland (HES-SO), CH-1401 Yverdon-les-Bains, Switzerland

Bacterial resistance to antibiotics originating from misuse and overuse is becoming a major public health issue especially in developing countries. The cause of infection, whether bacterial or viral, is crucial to provide patients with the appropriate therapy and requires accurate detemination. Currently, this diagnosis is based on the detection of C-reactive protein (CRP), a protein present in blood, whose level increases when inflammation occurs. Recent studies involving the University Hospital of Lausanne (CHUV) have demonstrated that the quantitative analysis of one or two additional biomarkers can enhance the specificity and sensitivity for the diagnosis. Although diagnostic tests are commercially available, for instance lateral flow assays (LFA), they are not suitable for applications in resource restrained settings, and/or are only qualitative or semi-quantitative and/or they do not allow for simultaneous measurement of several biomarkers. Here, we want to address these needs through the development of a new type of quantitative multiplex tests based on LFA by combining commercially available portative fluorescence readers with strips of paper modified for accurate quantification of biomarkers. For this purpose, several technological advances will be integrated together: Supramolecular biosensors that modulate fluorescence in function of biomarker concentrations will be spotted into microfluidic reservoir structures printed on paper. Plasma will be extracted from a drop of whole blood using a filter membrane and brought to the reservoirs by capillary action. We will present our latest results with the successful structuring of microfluidic reservoirs in paper for multiplex measurements, the development and testing of supramolecular constructs and the interfacing of blood filter membranes with the paper microfluidics. Our novel test strips will offer a new type of quantitative and rapid point-of-care diagnostic test that could be generically applied for various blood analysis.


[Poster 2]

TUCUXI as a drug blood concentration POC interpreter

Yann Thoma(1), Yannis Jeannotat(1), Séverine Petitprez(2), Thierry Buclin(2)

(1) HES-SO // HEIG-VD // REDS, (2) CHUV

Currently many POC systems are being developed in order to analyze medical drug blood concentration. They aim at speeding up a usually heavy process involving analysis labs. Getting concentration values in 10 minutes will be more common in the future, but such values are not easy to interpret, even by trained practitioners. In that context, TUCUXI aims at helping the medical doctors and pharmacologists with the interpretation of medical drug concentration measures. This software is able to predict blood drug concentration based on any available information. It can take advantage of patient covariates (age, weight, …), and more specifically on concentration measures. It also computes percentiles to evaluate the normality of the patient response, and proposes dosage adjustments. While pharmacologists for helping them with their interpretations can use the current software, it can be embedded in a POC system in order to automatically propose an interpretation based on the observed concentration. Its use will allow to build POCs for blood concentration measurements not only as “dummy” machines giving a number, but as more advanced “intelligent” systems able to guide the practitioner with decisions about potential dosage adjustments. The current software will also be compatible with tablets or smartphones, and as such, these devices could be connected to a POC and serve as an interpretation helper.


[Poster 3]

Malaria detection POC system

Roberto Rigamonti, Alberto Dassatti, Yann Thoma

HES-SO // HEIG-VD // REDS The MOVABLE project aimed at developing a quantitative system able to count

infected and normal blood cells with image analysis methods. More precisely, its objective was to automatize the detection of blood cells infected by malaria parasites and to estimate the parasitemia or the ratio of infected cells to the total number of red blood cells. This ratio is an important measure driving the patient’s therapy. The current WHO standard prescribes a complex, error prone, manual procedure that requires highly trained technicians.

The software developed at HEIG-VD is based on a supervised learning algorithm. It

exploits the knowledge of practitioners to learn what the infected cells look like, and this over time allows improving detection accuracy as more and more examples are presented to the system. A graphical user interface has also been developed to ease the visualization of the acquired images along with the infected cells detected.

This software is under clinical evaluation by the team of Dr. Guy Prod'Hom (CHUV) to

validate its potential in terms of clinical use. The current setup requires a high-end microscope for image capture, and as such is not very well suited for developing countries. Therefore, a newly started project, H3PoC, aims at embedding the system as a POC, with a custom optical setup, in order to allow its use in such areas, leveraging a low cost hardware implementation.


[Poster 4]

DrugSens: A system for Continuous Monitoring of the Anticancer Agent Methotrexate in Patient's Blood

S. Farine-Brunner (3), E. Condemi (1), M. Geiser (2), E. Hochstrasser (3), A. Homsy (3), L.

Jeandupeux (3), R. Marti (4), M. E. Pfeifer (1), Gabriel Rittiner (3), P. Roduit (2), C. Schalcher (4), J.-M. Segura (1), A. Sierro (2), A. Simalatsar (2), F. Telmont (3), and F. Truffer

(2)

(1) Institute of Life Technologies, HES-SO University of Applied Sciences Western Switzerland Valais, Sion, Switzerland; (2) Institute of System Engineering, HES-SO

University of Applied Sciences Western Switzerland Valais, Sion, Switzerland; (3) Haute Ecole Arc Ingénierie, HES-SO University of Applied Sciences Western Switzerland, La

Chaux-de-Fonds, Switzerland; (4) Institute of Chemical Technology, HES-SO University of Applied Sciences Western Switzerland, Fribourg, Switzerland

During cancer chemotherapies, patients are subjects to administration of high doses of

drugs during periods of time which can last up to several days. Ideally, drug doses should be continuously adjusted resulting in medicament blood concentrations being kept within a therapeutic range avoiding concentration peaks and thus greatly reducing side effects. This requires regular blood tests, typically every 15 to 30 minutes. An autonomous electronically controlled system able to continuously measure drug concentrations in blood would enable such monitoring and allow for prompt dosage adjustment.

The objective of this project is to integrate several novel technologies into a prototype

that would allow for quantitative monitoring of drugs in blood. We aim at creating an autonomous system allowing to perform measurements using supramolecular bio-sensors whose fluorescence is modulated by the presence of drugs.

Our most recent results in the development of this prototype are: 1) A micro-fluidic

system for the transfer of blood samples to a micro-chamber containing the bio-sensors; 2) A proprietary electronic controller to perform automatic blood sampling, continues delivery of samples to the bio-sensors and after measurement sensor cleaning; 3) A micro-chamber composed of a channel for continuous sample flow over a cavity containing the bio-sensors protected by a hydrogel; 4) An integrated optics system to measure the fluorescence rate emitted by bio-sensors.

Figure 1 Change of fluorescence intensity with the change of the pH of liquid flowing through the

microfluidic chamber over the cavity containing hydrogel with pH-sensitive fluorescent beads


[Poster 5]

Interoperability and Dynamic Data Aggregation for Therapeutic Drug Monitoring

Alevtina Dubovitskaya1,2, Thierry Buclin3, Michael Ignaz Schumacher1, Karl Aberer2, Yann

Thoma4

1Applied Intelligent Systems Laboratory, HES-SO VS; 2Distributed Information Systems Laboratory, EPFL; 3Division of Clinical Pharmacology, CHUV and University of Lausanne;

4Reconfigurable and Embedded Digital Systems Institute, HEIG-VD Therapeutic Drug Monitoring (TDM) is a key concept in precision medicine. The goal of TDM is to avoid therapeutic failure or toxic effects of a drug due to its insufficient or excessive circulating concentration in the blood of a patient. Expanding TDM to a larger patients population by making it available at the Point-of-Care (POC) system will further advance the outcome of drug therapies. A number of automated systems for TDM already exist [1]. However, insertion of such system into the existing network of electronic medical records, laboratory information system and other medical application is challenging due to the issues related to different interfaces, data formats, comprehensive clinical data flow. We describe the process of integration of an intelligent system for TDM (TUCUXI [2]) in clinical data flow. We first show how the interoperability was achieved: we present data structure, messages and interfaces designed to exchange the data. The collection of population data from daily use of the software would help to develop new and imrove existing drug models that describe how the body handles the drug and how the drug afftects the body. However, patients’ data are sensitive, studies may have very different scopes, and data aggregation is time consuming. In the second part of our work, we present a module that enables dynamic and privacy-preserving aggregation of the data for research purposes from multiple instances of the TDM software [3].

Figure 1: Integrating TDM software into clinical data flow.


[1] Fuchs, A., Csajka, C., Thoma, Y., Buclin, T., & Widmer, N. (2013). Benchmarking therapeutic drug monitoring software: a review of available computer tools. Clinical pharmacokinetics, 52(1), 9-22.

[2] Dubovitskaya, A., Buclin, T., Schumacher, M., Aberer, K., & Thoma, Y. (2017, August). TUCUXI: An Intelligent System for Personalized Medicine from Individualization of Treatments to Research Databases and Back. In Proceedings of the 8th ACM International Conference on Bioinformatics, Computational Biology, and Health Informatics (pp. 223-232). ACM.

[3] Dubovitskaya, A., Urovi, V., Barba, I., Aberer, K., & Schumacher, M. I. (2016). A Multiagent System for Dynamic Data Aggregation in Medical Research. BioMed research international, 2016.


[Poster 6]

IBDoc® - the first CE/IVD marked smartphone based home testing tool for the therapy follow-up by patients suffering from chronic inflammatory diseases

J. Weber1, C. Reinhard1, A. Beyer2, M.-E. Ueberschlag1, A. Ritz1, H. Vogelsang2

1BÜHLMANN Laboratories AG, Schönenbuch, Switzerland;

2AKH, Medical University, Vienna, Austria

Background: Inflammatory Bowel Disease (IBD) is a chronic inflammation of the gut comprising active inflammation, remission and flares, which can be monitored by measuring the surrogate biomarker, fecal calprotectin (fCAL). One of the IBD therapy goals is to achieve mucosal healing and to keep fCAL below 250 μg/g. IBDoc® allows non-laboratory-professional subjects to regularly perform fCAL testing at home and to check whether the level of fCAL is under control.

Objectives: 1) To perform a method comparison of the smartphone-based IBDoc® home testing system to the gold standard ELISA procedure performed in the lab; 2) to compare results from IBDoc® performed by lay users versus lab professionals using the IBDoc®; 3) to perform a usability study with active IBD patients naïve to the IBDoc® system.

Methods & Results: 240 single IBDoc® values (40 fecal samples) were compared to fCAL® ELISA (slope=1.07, intercept=-2.2 μg/g, bias=+5.9%, R2=0.859). For the second objective, 26 different stool samples were analyzed by 31 lay users and 2 laboratory professionals both using IBDoc® with their own smartphone. The quantitative results of the lay users were correlated to the results of the professionals (slope=0.96, bias=-1.5%, R2=0.945) The total within-class agreement was 96.8%. Eight voluntary IBD patients (AKH, Vienna) were trained to use IBDoc®, performed five consecutive tests at home and filled in a questionnaire after the first and last test.

Conclusions: IBDoc® performance is well comparable to professional, laboratory-based ELISA methods. There is no substantial difference in the semi-quantitative test results generated by lay users as compared to laboratory professionals. IBDoc® well-accepted by patients. IBDoc® is the first completely validated CE-IVD test which allows a person to self-monitor his/her inflammatory status by measuring the IBD biomarker, fecal calprotectin, at home using his/her own smartphone.


[Poster 7]

Rapid determination of the inflammation marker Calprotectin in serum from patients with inflammatory arthritis at the point of care

N. Ryter1, A. Szentpetery2, S.R. Pennington3, R. Cotti1, O. FitzGerald2,3, J.M. Weber1

1BÜHLMANN Laboratories AG, Schönenbuch, Switzerland; 2 St Vincent’s University Hospital;

3University College Dublin, Ireland

Background: A Treat-to-Target (T2T) strategy for inflammatory arthritis, targeting remission or minimal disease activity, is the recommended treatment approach. This strategy relies on “tight monitoring” which necessitates regular clinical examination and measuring acute-phase reactants such as C-reactive protein. Calprotectin (MRP8/14; S100A8/A9), a relatively novel inflammation and disease activity marker in the arthritis field, exhibits several features which fit the “theranostic needs” for accurate therapy monitoring. Those features include discrimination between responders and non-responders [1], detection of subclinical disease activity [2] and prediction of relapse or radiographic progression [3]. The classical method to determine calprotectin in serum (sCAL) is ELISA applied in central laboratories. Therefore, a rapid and simple determination of sCAL at the point of care would be a substantial step in supporting clinicians to deliver an efficient T2T strategy.

Objectives: (1) To demonstrate the performance evaluation of a rapid, quantitative sCAL lateral flow assay combined with a dedicated test reading device; and (2) to compare its results to a well-established laboratory reference method.

Methods: Quantum Blue® sCAL sandwich lateral flow immunoassay was run according to the manufacturer’s instructions and then measured with the Quantum Blue® reader (BÜHLMANN, Schönenbuch). Performance evaluation (sensitivity, linearity, high-dose hook effect, interferences) was carried out according to CLSI guidelines. A method comparison based on 178 serum samples from RA and PsA patients was performed against the BÜHLMANN sCAL (MRP8/14) ELISA.

Results: The linearity study over the complete measuring range together with the observed limit of quantification (LoQ = sensitivity) of <0.5 μg/mL allowed a quantitative measurement in the clinically relevant range from 0.5 to 10.0 μg/mL. No interferences were detected with triglycerides (37 mmol/L), conjugated bilirubin (342 μmol/L), unconjugated bilirubin (342 μmol/L), and hemoglobin (200 mg/dL). The Quantum Blue® sCAL lateral flow assay showed an excellent linear correlation (r=0.94, slope=1.05) to the reference ELISA method. A negligible bias of -3.1% by Bland-Altman was observed.

Conclusions: Rapid quantification of serum calprotectin using the Quantum Blue® sCAL assay represents a fast and reliable method for the determination of inflammation and the disease activity of patients with inflammatory arthritis at the point of care. This rapid test shows excellent agreement to a corresponding laboratory reference method.

References 1. Anink J. Arthritis Res Ther (2015);15:200 2. Inciarte-Mundo J. Arthritis Res Ther (2016);18:160 3. Hurnakova J. Arthritis Res Ther (2015);17:252


[Poster 8]

Evaluation of a pad printed affinity biosensor suitable for large-scale production

Adyl-Michaël El Guamra1, Enrico Condemi2, Marc E. Pfeifer2 and Philippe A. Passeraub 1,

*

1 Institute of Sciences and Industrial Technologies, University of Applied Sciences and Arts Western Switzerland HES-SO, Geneva 1202, Switzerland; E-Mails: adyl-

[email protected]; [email protected], 2 Institute of Life Technologies, University of Applied Sciences and Arts Western Switzerland HES-SO, Sion 1950,

Switzerland; E-Mails: [email protected]; marc.pfeifer@hevs; *Author to whom correspondence should be addressed

Purpose: Pad printed electrode arrays for electrochemical biosensing applications are still hardly explored despite the ease of miniaturisation and its suitability for mass production. The aim of this study was to develop a label-free affinity biosensor with a pad printed electrode array for the quantification of cMyc-antibody (the target) in deionized water.

Methods: The electrode microfabrication is achieved with an industrial pad printing machine on 25μm thick polyimide film followed by electrodeposition of a thin gold layer. The ligand layer composed of a cMyc peptide was immobilised on the electrode surface with commonly used molecular self-assembly to bind the target. Sensor performance was compared with ELISA-type assays. Quantification of the captured target was conducted by electrochemical impedance spectroscopy (EIS) without a redox probe. Results: The electrodes were successfully functionalised and could be employed to quantify the target in relevant physiological concentration ranges after only 15 minutes of incubation time with good assay repeatability. However reproducibility between sensors was not optimal and requires further optimizations. An equivalent electrical circuit was identified. Its analysis showed that no capacitance change occurred during the self-assembly, but that instead a charge transfer resistance change was correlated with new molecular layer and target concentrations. Furthermore proportionality between the area of electrode with adsorbed target and charge transfer resistance was postulated. Based on this assumption data was normalised with this resistance and the reproducibility response between sensors was significantly improved. Discussion: The results obtained show that pad printing is suitable for building electrodes for affinity biosensors and to make reproducible responses possible bearing in mind that normalisation is required with the charge transfer resistance. Compared to other affinity biosensors described in the literature, the biosensors presented in this study are more easily manufacturable and show an equivalent or better analytical sensitivity, i.e. lower limit of detection (LOD).


[Poster 9]

Small-drug quantification from whole blood within paper- based microstructures for Point-Of-Care Therapeutic Drug Monitoring

Diana Bojescu, Denis Prim, Marc Pfeifer, Jean-Manuel Segura*

Institute of Life Technologies, University of Applied Sciences and Arts Western Switzerland

Valais, Route du Rawyl 64, 1950 Sion

Therapeutic Drug Monitoring (TDM) allows for personalized treatment of illnesses where continuous control of drug dosage is required in order to avoid adverse effects. Currently, this process is demanding for the patient, costly and time consuming. For this reason, point-of-care whole-blood tests are desirable as they would offer accelerated monitoring from a single drop of blood.

To make such a point-of-care test possible, we investigated the ability of paper-like membranes to run quantitative clinical immunochemistry using Fluorescence Polarization Immunoassay (FPIA) as a tool for direct quantification of small molecules in whole blood. Paper and paper-like microstructures are excellent supports for diagnostic tests due to several key properties such as biocompatibility, three-dimensional fibrous structure, high surface area and facilitated storage of dried reagents. Paper has been widely explored lately for applications such as quantification of drugs of abuse in the lateral flow assay format or direct synthesis of DNA in paper. Even though paper is extensively used in diagnostic tests, the direct quantification of small drugs combined with sample preparation is still limited. Moreover, fluorescence Polarization (FP) has not been associated with paper mainly due to the intrinsic fluorescent background.

Here we demonstrate that the feasibility of such a measurement directly within paper is made possible by using labeling with near-infrared fluorescent (NIR) dyes in a spectral region with low autofluorescence from the whole blood samples and the paper itself. A competitive immunoassay was implemented within the micro-cavities of the paper-based microstructures. Different types of paper-based membranes were screened in terms of fluorescent background and scattering effects. We tested the ability to measure Fluorescence Polarization by registering anisotropy in these microstructures at different concentrations of Tobramycin, a 465 Da antibiotics, covering its therapeutic range (1 – 10 μg/mL). Beyond their use as measurement micro-chambers, the paper-like membranes further enabled filtering of blood cells and extraction of plasma. Our current assay only requires straightforward mixing of the reagents with 10 L of whole blood, incubation and addition to the paper-like microchambers for direct read-out of the fluorescence polarization and drug quantification.

Fig. 1: Whole blood filtration and quantification of Tobramycin through FPIA: a) Collection of capillary blood using a) Fingerprick; b) Incubation with the reagents; c) Addition to the paper-like microchamber; d) Recording and quantification.


[Poster 10]

Screen-Printed Electrodes as a Platform for Smart and Low-Cost Point of Care Devices

D. Migliorelli, S. Generelli, N. Glaser, M.Viviani, L. Muehlebach, R. Junuzovic

CSEM Centre Suisse d’Electronique et de Microtechnique SA, Bahnhofstrasse 1,

CH-7302 Landquart, Switzerland

Screen-printing is one of the most promising approaches towards simple, rapid and inexpensive production of biosensors and it is particularly suited to the mass production of low-cost disposable biosensors. One of the most prominent commercialized applications of screen-printed electrodes is the glucose biosensor used for diabetes, which represents a billion dollar per year global market. This shows the potential of commercialization of screen-printed sensors (or biosensors) point of care devices for applications with a significant global market.

CSEM is a research and technology organization specialised in the transfer of technologies and know-how from fundamental research to industry; and point of care devices based on screen-printed sensors technology is one of the fields where CSEM is involved in terms of technology-based activities that address the next generation of trends. Our fields of activity comprise, among others, wearable technologies for wellness and medical applications and development of point of care testing for diagnostics. Recent projects were focused on the development of point of care systems for the detection of biomarkers in non-invasive body fluids. Systems for tuberculosis detection by urine analysis or diagnosis of kidney diseases by saliva analysis were realized.


[Poster 11]

Point-of-Care analytical platform for Therapeutic Drug Monitoring

Denis Prim1, Diana Burghelea1, Helene Strese2, Frederic Truffer2, Serge Amoos2, Martial Geiser2, Jean-Manuel Segura1, Marc E. Pfeifer1

1 Life Technologies Institute, University of Applied Sciences and Arts Western Switzerland

Valais, Route du Rawyl 64, 1950 Sion 2 Systems Engineering Institute, University of Applied Sciences and Arts Western

Switzerland Valais, Route du Rawyl 47, 1950 Sion

Therapeutic Drug Monitoring for personalized dosage during therapeutic treatments is often mandatory for modern potent drugs against e.g. cancer, HIV or in organ transplantation cases. We aim at developing a minimally invasive Point-of-Care (POC) device that allows quantification of small drug molecules in blood with fast turnaround, based on fluorescence polarization immunoassays. Multiple demonstrators with increasing integration were developed until the end of the Nano-Tera. The final demonstrator is expected to include a sample preparation cartridge to process whole blood and combine reagents required to quantify drugs by fluorescence polarization immunoassays (FPIA). The instrument itself is composed of an optic module, an embedded computer to process measured values and data transmission protocols to research and clinical databases. Results obtained on our demonstrator are promising and show feasibility in quantification of Tobramycin in whole blood samples based on ISyPeM2 developed technologies.


[Poster 12]

Analysis cartridge for companion diagnostics

S. F. Graf, T. Volden, S. Berchtold, J. Goldowsky, N. Schmid, V. Revol, H. F. Knapp

CSEM SA, Untere Gründlistrasse 1, CH-6055 Alpnach Dorf The most viable defense against cancer morbidity is to be able to detect the cancer early enough and then treat it adequately. For this purpose Point-of-Care (PoC) devices are required which deliver reliable, accurate and fast results. Together with a consortium CSEM is developing such a PoC device to detect and monitor cancer based on specific proteins. For this purpose a disposable analysis cartridge with integrated whole blood filter and bio-functionalized optical chip is being developed. The cartridge design addresses the requirements such as user friendliness, low sample volume, highly reproducible flow, avoidance of air bubbles on the sensing area and the compatibility for mass production.

PARTICIPANTS LISTLast Name First Name Company Name Country

Allibert Patrice GenePOC Canada

Amiet Franziska Inselspital Switzerland

Andlauer Wilfried HES-SO Valais Switzerland

Bagnoud Frederic CimArk Switzerland

Benoit Pierre Siemens Healthineers Switzerland

Besazza Nadja Bühlmann Laboratories AG Switzerland

Bezinge Léonard ETH Zürich Switzerland

Bojescu Diana HES-SO Valais Switzerland

Bonazzi Riccardo HES-SO Valais Switzerland

Calmin Gautier HES-SO Switzerland

Calvaresi Davide HES-SO Valais Switzerland

Camenzind Robin maxon motor AG Switzerland

Cherix Gaëtan HES-SO Valais Switzerland

Collins James Okapi Theranostics Switzerland

Cotting Alexandre HES-SO Valais Switzerland

Coumou Hilde Sensirion AG Switzerland

Crettenand Alexia HES-SO Valais Switzerland

Dayer Camille Swiss Biotech Center Switzerland

Dayer Cynthia Adipogen SA Switzerland

Delaloye Matthieu HES-SO Valais Switzerland

Demian Paul Menicon Co., Ltd., Geneva RD Innovation Center Switzerland

Dergai Oleksandr University of Lausanne Switzerland

Dettwiler Guido Bühlmann Laboratories AG Switzerland

Deuschel Christine Debiopharm International SA Switzerland

Donzé Olivier Adipogen SA Switzerland

Dowe Tanja Debiopharm Innovation Fund Switzerland

Ducrest Percevent HES-SO Valais Switzerland

Dumoulin Alexis Hôpital du Valais - Institut Central des Hôpitaux Switzerland

El Guamra Adyl Menicon Co., Ltd., Geneva RD Innovation Center Switzerland

Ferrini Rolando CSEM SA Switzerland

Fischer Fabian HES-SO Valais Switzerland

Fleury-Siegenthaler Michèle Office fédéral de la Santé publique Switzerland

Forster Vincent Versantis Switzerland

Frutiger Andreas ETH Zürich Switzerland

Fusco Jonathan Debiopharm Research & Manufacturing SA Switzerland

Generelli Silvia CSEM AG Switzerland

Gill Ron Biovolt BV Netherlands

Goudou Orianne Siemens Healthineers Switzerland

Graf Siegfried CSEM SA Switzerland

Guiducci Carlotta Ecole Polytechnique Fédérale de Lausanne (EPFL) Switzerland

Guignet Emmanuel Bio-Rad Switzerland

Gygax Daniel NTN Swiss Biotech and FHNW Switzerland

Haenni François Hôpital du Valais - Institut Central des Hôpitaux Switzerland

Hanik Nils HES-SO Valais Switzerland


Heinzelmann Harry CSEM SA Switzerland

Hejazi Zahra ETH Zürich Switzerland

Henderson Charley PA Consulting United Kingdom

Heuschkel Marc HEPIA Switzerland

Hsiao Jeff ETH Zürich United States

Hübner Aurélie CimArk Switzerland

Ikeda Tomohiro Menicon Co., Ltd., Geneva RD Innovation Center Switzerland

Jaeggi Rainer Roche Diagnostics International Ltd. Switzerland

Jeandupeux Laure Haute Ecole Arc Ingénierie Switzerland

Joris Claude BioAlps Switzerland

Kappeler Natascha University of Applied Sciences and Arts, FHNW Switzerland

Knapp Helmut CSEM SA Switzerland

Koenig Isabelle Switzerland

Kübler Eric University of Applied Sciences and Arts, FHNW Switzerland

Kühne Micha Rychiger AG Switzerland

Leichtle Alexander Inselspital - Bern University Hospital Switzerland

Lommele Alain Bio-Rad Switzerland

Loubereau Jean-Frédéric Delpharm Biotech France

Loze Chantal ABCDx SA Switzerland

Marc Mathieu HES-SO Valais Switzerland

Marti Roger Haute école d’ingénierie et d’architecture Fribourg Switzerland

Mathis Christian SuSoS AG Switzerland

Mazza Graziella Federal Office for the Environment Switzerland

Mentek Marielle Menicon Co., Ltd., Geneva RD Innovation Center Switzerland

Mermoud Yves EMPA Switzerland

Moreau Emmanuel Philips Handheld Diagnostics Netherlands

Naveiras Olaia Ecole Polytechnique Fédérale de Lausanne (EPFL) Switzerland

Nobile Massimo Swiss Biotech Center Switzerland

Nyanguile Origene HES-SO Valais Switzerland

Paoletti Samantha CSEM SA Switzerland

Paratore Federico IBM Research Zurich Switzerland

Parchet Grégoire Swiss Biotech Center Switzerland

Pattky Martin HES-SO Valais Switzerland

Pellaton Pierre maxon motor AG Switzerland

Pfeifer Marc HES-SO Valais Switzerland

Piantini Umberto HES-SO Valais Switzerland

Prim Jacqueline HES-SO Valais Switzerland

Prim Denis HES-SO Valais Switzerland

Queval Arthur Qloudlab SA Switzerland

Rebeaud Fabien Abionic SA Switzerland

Renaud Philippe Ecole Polytechnique Fédérale de Lausanne (EPFL) Switzerland

Robichon Denis DDX Diagnostic Disease Expertise Sarl France

Roduit Pierre HES-SO Valais Switzerland

Roig Ramon LabCorp/Covance Switzerland


Rossier Michel Hôpital du Valais - Institut Central des Hôpitaux Switzerland

Roulin Samuel Swiss federal Office of Public Health Switzerland

Roux Adrien HEPIA Switzerland

Ryser Peter Ecole Polytechnique Fédérale de Lausanne (EPFL) Switzerland

Sadler Stephanie HES-SO Valais Switzerland

Sager Cédric Debiopharm Research & Manufacturing SA Switzerland

Sanchez Jean-Charles University Medical Center Geneva Switzerland

Schawaller Manfred Davos Diagnostics AG Switzerland

Schmid Sergio HES-SO Valais Switzerland

Schneider Urs Philips Switzerland

Schnyder Bruno HES-SO Valais Switzerland

Segura Jean-Manuel HES-SO Valais Switzerland

Senn Nicolas Policlinique Médicale Universitaire Switzerland

Silvany Claudia CSEM SA Switzerland

Simalatsar Alena HES-SO Valais Switzerland

Steiger Christelle Laboratoire Salamin Switzerland

Steinwand Michael Innovendia Germany

Suea-Ngam Akkapol ETH Zürich Switzerland

Tanno Alexander ETH Zürich Switzerland

Thoma Yann HEIG-VD Switzerland

Thomas Yves CLINILINE Switzerland

Tosatti Samuele SuSoS AG Switzerland

Truffer Frederic HES-SO Valais Switzerland

Uhr Mario Clinica Luganese Switzerland

Ulrich Dieter CSEM SA Switzerland

Vanbiervliet Morgane Debiopharm International SA Switzerland

Verelst Peggy GenePOC Canada

Walker Anne HES-SO Valais Switzerland

Weber Jakob Bühlmann Laboratories AG Switzerland

Whitesides Barbara United States

Whitesides George M. Harvard University United States

Wicki Marie José Laboratoire Salamin Switzerland


PERSONAL NOTES

Swiss Symposium in POC 2017 - hevs.ch

Documents

Transcript of Swiss Symposium in POC 2017 - hevs.ch