Cambridge Healthtech Institute’s 4th Annual

Point-of-Care Diagnostics

Achieving Better Outcomes

8-9 May 2019


The market for point-of-care diagnostics is projected to surpass $38 billion by 2022, and rapid testing is changing the paradigm for clinical care across many disease areas. Technologies and platforms are being optimized for speed and reliability in a variety of settings, including bedside, resource-limited and pharmacy testing. The Point-of-Care Diagnostics conference will bring together leaders across Europe, US and Asia to discuss the current state-of-the-art in POCT as well as trends and clinical applications.

Final Agenda



11:35 Moderator’s Remarks

Charlotte Ryckman, Associate, Covington & Burling LLP, Belgium

11:45 Precision Diagnostics in Oncology: Expanding Roles of Liquid Biopsies

Nitzan Rosenfeld, PhD, Senior Group Leader, Cancer Research UK Cambridge Institute, University of Cambridge; CSO, Inivata Ltd., United Kingdom

Effective clinical management relies on accurate diagnostic information, which requires effective techniques and the right samples. Next generation sequencing can provide a wealth of information, but implementing innovative technologies into clinical routine can be a challenge. We’ll examine how analysis of cell-free DNA can provide an opportunity to re-examine many of the current clinical decision points, and a test case for adoption of new diagnostic tools.

12:15 Legal and Regulatory Developments in Precision Medicine and Diagnostic Devices

Erik Vollebregt, Partner, Axon Lawyers, The Netherlands

  • What changes will be brought about by the IVDR?
  • What is the impact of the GDPR in the field of precision medicine and diagnostic devices?
  • What are the practical implications of implementation of new European regulations?
  • What are the consequences of the interplay of the IVDR and the GDPR?

12:45 PANEL DISCUSSION: Challenges and Opportunities in European Diagnostic Investments


Philippe Peltier, Partner, Kurma Partners, France


Florian Kainzinger, PhD, Managing Partner, Founder, Think.Health Ventures, Germany

Makinen_SeppoSeppo Mäkinen, Partner, Pathena Investments

  • What is different in Europe versus other markets (e.g., US and Israel). How do different European markets compare?
  • What has changed in the landscape of European investments over the past few years? What can be improved?
  • The role of regulators and governments
  • How can start-ups stand out and get attention in the current landscape?



14:30 Chairperson's Remarks

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


14:35 KEYNOTE PRESENTATION: Point-of-Care Diagnostics in Europe – How to Improve Selectivity of Antibiotics Use

Anders Larsson, MD, PhD, Professor, Department of Clinical Chemistry and Pharmacology, Uppsala University Hospital, Sweden

Antibiotics resistance will force us to be more selective when prescribing antibiotics. This will require POC test that can distinguish between bacterial and viral infections. POCT instrument that utilizes single sample cuvettes and image analysis of full blood cell counts will allow hematology POCT also at small units including GP offices, operating theatres and emergency departments. The new assays for neutrophil activation markers could also aid in these decisions.

15:05 Point-of-Care Creatinine Testing in Community Acquired Acute Kidney Injury Associated with Infection

Dimitrios PoulikakosDimitrios Poulikakos, MD, Consultant Renal Physician and AKI Lead, Renal Department, Salford Royal NHS Foundation Trust, United Kingdom

Acute kidney injury (AKI) is associated with poor outcomes. The presence of AKI in the context of suspected community acquired infection confers very high risk of morbidity and mortality and therefore can be used for risk stratification purposes. The talk will present the results of a recent evaluation project of the use point-of-care creatinine testing for early identification and management of infection associated AKI.

15:35 Point-of-Care Hemostasis Monitoring in Major Surgeries: Issues and Challenges

Antonio León JustélAntonio León Justél, PhD, CEO, Huelva University Hospital, Spain

Due to the complex nature of the haemostatic routine, laboratory plasma coagulation tests running in the main laboratory, such as INR and aPTT, are not sufficient to diagnose specific coagulation defects and to guide haemostatic therapy. Point-of-care (POC) testing may overcome some of the limitations of traditional approaches to haemostasis management. We presented a success application case of POC-guided haemostatic therapy in major surgeries.

16:05 Refreshment Break in the Exhibit Hall with Poster Viewing

17:05 Glucose Monitoring in Critically Ill Patients

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

Tight glycemic control by POCT has become the standard of care over the years for inpatients, including critically ill patients. Regulatory oversight resulted in restrictions and a debate about proper inpatient glycemic management because none of the POC glucometers were cleared by the US FDA for this patient population. The talk will review the related guidelines and present data on clinical situations when POC finger-stick glucose results may be significantly inaccurate.

17:35 Implementation of Point-of-Care Tests: Clinical Efficacy, Safety, and Cost-Effectiveness

Michelle M.A. KipMichelle M.A. Kip, PhD, Postdoctoral Researcher, Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, The Netherlands

Although a large set of point-of-care tests is currently available, only few are used in clinical practice. One example of a test that is (still) used infrequently, is point-of-care troponin. This test is used to rule-out acute coronary syndrome in general practices. Using this case study, the presentation will provide insights in factors affecting test implementation and use in clinical practice and in methods applied to quantify the test’s cost-effectiveness.

18:05 Converging Human, Animal, and Vector Diagnostics, Together with Digital Technologies, Towards a Holistic One Health Approach

Konstantinos MitsakakisKonstantinos Mitsakakis, PhD, Head of International Business Development, Hahn-Schickard Institut für Mikroanalysesysteme, Freiburg, Germany

Diseases such as malaria, dengue, chikungunya, zika share several common features: they are all vector-borne, account for more than 17% of all human infectious diseases, frequently emerge as epidemics, and tend to spread from tropical to non-tropical regions. The presentation will propose pathways to converge human and vector diagnostics through four disciplines, namely: molecular assays, point-of-care diagnostic systems, information and communication technologies, behavioral change, towards a One Health approach.

18:35 Innovative POCT Technologies: An Overview on New Revolutionary Products and Their Influence on Digitalization, Process Optimization and Costs

Peter B. LuppaPeter B. Luppa, PhD, Head, Central Laboratory, Institute for Clinical Chemistry, Technische Universität München, Germany

Emerging technologies enable the development of revolutionary POCT. The new techniques include alternative biological detection elements, microarrays, as well as new nucleic acid testing analytics for infection, inflammation, malignancies and autoantibody diagnostics. These techniques will be encouraged through novel digitalization concepts. As example for disruptive techniques, the continuous glucose monitoring will be discussed. The application fields are illustrated by clinical examples in intensive care units and in outpatient (diabetes) ambulances.

19:05 Close of Day


08:30 Registration and Morning Coffee


09:00 Chairperson's Remarks

Prof. Dr. Dr. Wilfried von Eiff, Director, Center for Hospital Management, University of Muenster, Germany

09:05 “Theragnostic” and the Burden of Disease: How Misleading Reimbursement Systems Cause Avoidable Costs and Harm to the Patient

Wilfried von EiffProf. Dr. Dr. Wilfried von Eiff, Director, Center for Hospital Management, University of Muenster, Germany

In Germany, nearly 210.000 patients infected with multi-resistant bacteria were undetected and admitted to hospitals. Otherwise, only 45.000 MRSA-related diagnostic and therapeutic interventions are carried out by General Practitioners. This screening gap leads to needless harm for patients and avoidable costs. This diagnostic gap is caused by a misleading reimbursement system that pays only for therapy e.g. for MRSA-infected persons but not for screening in the forefield of a hospital stay.

09:35 Quality Management at the Point-of-Care

Claus LangerClaus Langer, PhD, Clinical Chemist, Medizinisches Versorgungszentrum for Laboratory Medicine and Mikrobiology (mvzlm Ruhr), Germany

The successful implementation of quality management is a challenge in the area of Point-of-Care testing (POCT). In our collaboration with different hospitals, these problems create constantly new challenges. At the same time, it is important to integrate the aspects of quality management for POCT into the QMS of the hospital. The goal of better quality management at POCT requires constructive cooperation between all stakeholders.

Chroma-Technologies 10:05 Use of Optical Filters in PoCT Instruments

Georg Draude, PhD, General Manager, Chroma Europe, Chroma Technology, Germany

This talk is to give a quick overview on the key role of optical filters in medical applications. Examples are shown with devices for cardiovascular risk assessment and age levels measurements, that uses optical applications as core technology.

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

11:20 Precision Medicine: New Biophotonic Approach for Testing Antibiotic Resistance

Ute NeugebauerProf. Dr. Ute Neugebauer, Professor, Physical Chemistry, Center for Sepsis Control and Care, Jena University Hospital & Leibniz Institute of Photonic Technology, Jena, Germany

Increasing antibiotic (multi-)resistances of pathogens require fast diagnostics to administer tailored antibiotic therapy in time. Here, biophotonic bacterial identification as well as fast antibiotic susceptibility testing are presented, starting directly from patient’s body fluids, such as urine. Phenotypic resistances are available after only 90 – 360 minutes and can be obtained in a qualitative manner (sensitive vs. resistant) as well as in a quantitative manner displaying the minimal inhibitory concentration.

Sagentia_new 11:50 Finding Solutions for Sample Preparation at Point of Care

Collier_NickNick Collier, PhD, CTO, Medical, Sagentia, United Kingdom

As molecular diagnostics move to point of care, lab-based processes are being adapted. One area that is sometimes neglected is sample preparation. This presentation assesses current lab techniques and their suitability to PoC; the range of cartridges currently available; techniques that could be used such as electrowetting, magnetic beads and ultrasonics and reviews the scientific literature, suggesting emerging techniques.

12:05 Sponsored Presentation (Opportunity Available)

12:20 Enjoy Lunch on Your Own


13:50 Chairperson's Remarks

Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany

14:00 The Quest for Sample-In Answer-Out – Developing Highly Integrated Cartridges for POC Applications

Holger BeckerHolger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany

With the advent of highly integrated microfluidic devices which allow a sample-in answer-out operation without additional hands-on time, the original concept of a lab-on-a-chip is becoming a reality in many diagnostic applications. For the development and industrial manufacturing of such devices however, significant challenges exist during product development and in the subsequent transition to manufacturing. The talk will explore solutions to such challenges such as material selection, on-chip reagent storage and fluidic manipulation in order to not only end up with a functional but also a commercially viable device. Examples from different fields of point-of-care diagnostics such as molecular diagnostics, immunoassays and cell-based assays will be presented.

14:30 Commercialization of Microfluidic Devices for Point-of-Care Application

Vincent LinderVincent Linder, PhD, Founder and President, CDP BioMedical Consulting, Portugal

Development strategies can initially focus on de-risking analytical and clinical performances. For a successful commercialization effort, it is essential to also implement at the onset of the program a comprehensive vision encompassing the patient presenting in a POC setting, the POC user and all the steps needed to obtain an actionable test result. This presentation will discuss important commercialization challenges of Point-of-Care devices and directions/solutions to address them.

15:00 Development of Molecular and Antibody-Based Point-of-Care Tests for the Rapid Detection of Carbapenemases for Screening and Bedside Testing in the Private-Public Partnership InfectoGnostics

Gerd H. LuedkeSascha Braun, PhD, Senior Scientist, Optical-Molecular Diagnostics and System Technology, Leibniz Institute of Photonic Technology e.V. Jena (Leibniz-IPHT), Germany

The effective translation of scientific results to clinically applicable products is a challenge, which also requires an understanding of the implications and rules of industrial product development, guidelines and approvals. These can be organized and implemented, for example, in scientific projects in public-private partnerships. Using the InfectoGnostics Research Campus as example, concrete project results from the field of diagnostic test developments for antimicrobial resistant bacteria are shown.

Paratus-Diagnotstics 15:30 Point-of-Care Testing for Periodontal Disease

Carrano_JohnJohn Carrano, Chairman & CEO, Paratus Diagnostics, USA

We are developing a simple, low-cost medical device that can accurately diagnose periodontal disease at the dentist office – and during the time of your appointment. Periodontal disease is not only a serious condition because it will lead to tooth or even implant loss, but most importantly because of its direct role in contributing to several potentially fatal chronic diseases. Our device consists of a smartphone as the instrument and a one-time use cartridge.

16:00 Rapid Molecular Diagnostics for Severe Acute Infections

Gerd H. LuedkeGerd H. Luedke, PhD, Director Innovation, Technology & IP, Curetis GmbH, Germany

Antibiotic resistance is a major threat for severe acute infections. Early adequate antibiotic treatment allows improved patient outcomes. However, it requires fast diagnostics of pathogens and resistances to guide therapeutic intervention. Within recent years, several systems for rapid diagnostics that could be placed outside central labs were developed. Clinical results and experiences with the Unyvero System demonstrate the value of rapid molecular identification of pathogens and resistances.

16:30 Novel Approaches for Minimally Invasive Point-of-Need (PON) Diagnostics

Stephen C. FrancesconiStephen C. Francesconi, PhD, Science and Technology Manager, Diagnostics and Detection Division, Chemical Biological Technologies Department, Research and Development Directorate, Defense Threat Reduction Agency (DTRA), United States

DTRA is pursuing the development of FDA-cleared, low cost, highly specific and minimally invasive point-of-need (PON) diagnostic platforms. Specifically, Joint Science and Technology Office-Chemical Biological Defense Program (JSTO-CBDP) is developing, optimizing and evaluating two lateral flow immunoassays (LFI) for the detection of Burkholderia pseudomallei and Yersinia pestis. Furthermore, DTRA JSTO-CBDP is developing a multiplexed, hand-held, single use, rapid PCR-based platform capable of detecting different strains of the Hantavirus.

17:00 Close of Conference