Point-of-care testing is pushing the boundaries of how hospitals and healthcare providers are able to deliver superior results to patients by enabling quick turnaround of diagnoses that guide more effective treatment decisions. Many new technologies and platforms are being developed that integrate the various functions of sample collection, detection of analytes, and readout. Plan to connect with international leaders of the point-of-care diagnostics community as they convene to share the latest technology and advancements in the field this May in Lisbon.
Final Agenda
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Recommended Short Course*
SC1: Technologies, Applications and Commercialization of Point-of-Care Diagnostics [View Detailed Agenda]
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany
This 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.
*Separate Registration required.
WEDNESDAY, 23 MAY
11:35 Plenary Introduction
John Carrano, CEO, Paratus Diagnostics, LLC, United States
11:45-12:15 The New EU IVD Regulation – What Will It Mean for Your Lab?
David E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady’s Hospital for Sick Children, Ireland
In May 2017, Europe passed a new Regulation on in vitro Diagnostic Devices (IVDs). The regulation sets up a framework for controlling the market for diagnostic tests within the EU, setting out standards for the design and manufacture of in-vitro diagnostic devices (IVDs) and providing mechanisms for the oversight of these standards. This presentation will outline the content of the new regulations, with a particular focus on molecular diagnostics, and highlight the new requirements for clinical laboratories.
12:15-12:25 Introduction: Medicinal Product Regulators Point of View: Scientific-Regulatory Aspects of Companion Diagnostics and Challenges for Validation during Clinical Co-Development (Quality-Related Aspects)
Jörg Engelbergs, PhD, Scientific Expert and Assessor Biomedicines (Quality, Non-Clinic & Personalized Medicine), Section Mono- and Polyclonal Antibodies, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
In Europe, the legislation for marketing of medicinal products (MP) and IVDs including predictive biomarker-based assays (Companion Diagnostics, CDx) are not directly linked which is challenging for co-development. The new IVDD involves MP regulators in the CDx review process for CE marking. This presentation will outline from the perspective of MP regulators the scientific-regulatory challenges for technical validation of CDx. Differences between exploratory assays and assays used for patient stratification, as well as aspects for complex assays will be addressed.
12:25-13:30 PANEL DISCUSSION: Changing Landscape for IVDs in the EU
Moderator:
Charlotte Ryckman, Covington & Burling LLP, Belgium
Panelists:
David E. Barton, PhD, Chief Molecular Geneticist, National Centre for Medical Genetics, Our Lady’s Hospital for Sick Children, Ireland
Jörg Engelbergs, PhD, Section Mono- and Polyclonal Antibodies, Scientific Expert Biomedicines, Quality, Non-Clinic & Personalized Medicine (Biomarker/CDx), Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Maria Judite Neves, Health Products Director, Health Products Directorate, INFARMED – National Authority of Medicines and Health Products, Portugal
Sue Spencer, Global Service Director, Regulatory, UL, United Kingdom
Andreas F. Stange, PhD, Vice President, MHS Global IVD, TÜV SÜD, Germany
Doris-Ann Williams, MBE, Chief Executive, British In Vitro Diagnostics Association (BIVDA), United Kingdom
- Practical impact of the new IVD Regulation
- Regulatory aspects of companion diagnostics
- Challenges for validation
- Role of IVDs in the market
14:30 Chairperson’s Remarks
Wilfried von Eiff, PhD, Professor, International Health Care and Hospital Management; Academic Director, Center for Health Care Management and Regulation, HHL, Leipzig Graduate School of Management; Director, Center for Hospital Management, University of Muenster, Germany
14:35 Digitalization of Healthcare: The New Role of POCT
Wilfried von Eiff, PhD, Professor, International Health Care and Hospital Management; Academic Director, Center for Health Care Management and Regulation, HHL, Leipzig Graduate School of Management; Director, Center for Hospital Management, University of Muenster, Germany
The “Digitalization of Healthcare” will contribute to unburden medical services from routine tasks (Smart Contract Function), to enhance precision in diagnosis and therapy (Precision Medicine, TheragNostic, Big Data) and to force the use of POCT technology in all areas of medical provision (primary care, emergency care, acute care, rehabilitation). Additionally, a new sector of care is predicted to emerge (first-line medicine), which is characterized by intensive use of POCT technology even deployed by patients at home.
15:05 Process Optimization in the Emergency Department by the Use of Point-of-Care-Testing (POCT) in Life-Threatening Conditions
Sandra C. Buttigieg, MD, PhD, FFPH, MSc, MBA, MMCFD, Associate Professor, Head, Health Services Management, Faculty of Health Sciences, University of Malta, Malta; Consultant, Public Health Medicine, Clinical Performance Unit, Mater Dei Hospital, Malta; Honorary Senior Research Fellow, School of Social Policy, College of Social Sciences, University of Birmingham, United Kingdom
Point-of-care testing (POCT) at the Emergency Department (ED) attains better objectives in patient care while aiming to achieve early diagnosis for faster medical decision-making. This study assesses the benefits of POCT in the ED by providing examples. We utilize multiple case study approach using Six Sigma. This study provides clear examples of the effectiveness of POCT in life-threatening conditions, as compared to the use of traditional central lab or the medical imaging department.
15:35 Smart Homes Technologies for Health Care and Well-Being
Joost van Hoof, PhD, MSc, Eur Ing, Professor, Urban Ageing, The Hague University of Applied Sciences, The Netherlands
Smart homes can help people monitor their health status, can support occupants in controlling the environment, connect residents with remote relatives and care professionals, and detect emergencies and notify others by generating alarms. Smart home technologies hold a great promise for the future of healthcare and well-being. Technology can support us within our homes, but not unconditionally. In this presentation, the complex field of smart home technology is presented.
16:05 Refreshment Break in the Exhibit Hall with Poster Viewing
17:05 POCT: Impact beyond the Point-of-Care
Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, United States
With integration and decentralization of healthcare delivery systems and shift of care from the hospital to the community, POCT is gaining ground. Advanced implementation includes secure data transfer into electronic medical records (EMR), notification/alerts to providers via personal digital devices with capability of bidirectional flow of results, knowledge resources, and clinical decision-support tools. EMR integrated with the laboratory information system enables instant access to POCT results across the system, collaboration of care teams, and assessment of impact on quality metrics.
17:35 Disruptive Technologies in Health Care: The Significance of Digital Innovations for POCT
Stefanie Steinhauser, PhD, Research Associate, Chair for Innovation and Technology Management, University of Regensburg, Germany
Disruptive innovations can substantially change industries and make their products and services cheaper and more accessible. Digital innovations present potentially disruptive innovations that represent a drastic departure from the predominant method of health care delivery. Ubiquitous connectivity and data availability as well as networks can foster POCT by providing additional data for rapid clinical decision making. Contrariwise, POCT can provide valuable inputs for digital applications such as telemedicine.
18:05 Health 4.0 – Together on a DigITal Journey
Sarah Peuling, Senior Solution Advisor, Center of Competence Clinicals & Innovations, Cerner Health Services Deutschland GmbH, Germany
Across the globe, health systems need to fundamentally transform how care is delivered to address long-term challenges through rising demand against fixed supply. Sustainable change requires large-scale transformation. Hospitals are facing a journey through technology adoption and maturity to drive performance, quality and safety improvements with opportunities and challenges for POCT.
18:35 Breakout Discussions
Will Molecular Diagnostic Replace Cell-Culture-Based Technologies in The Identification of Bacteria and Their Resistance to Antibiotics?
Filipe Arroyo Cardoso, CTO, Magnomics, Portugal
- In which circumstance molecular diagnostic is advantageous over cell culture?
- Which molecular diagnostic technology (micro-array, PCR-based, isothermal amplification, sequencing…) will be a real alternative?
- Is the detection of bacteria DNA informative enough for a correct identification of bacteria and their resistance to antibiotics?
- The real advantage of molecular point-of-care platforms is market dependent or will they always be advantageous?
Next Generation Sequencing
Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, Massachusetts, United States
- Molecular testing for cancer: PCR/FISH vs. Next Generation Sequencing? How large your panel should be: spot testing/multiplex panels, WES, WGS? What will be the impact of the new FDA outsourcing NGS test review to the New York State Department of Health (NYSDH) on the industry in the USA?
- NGS: Should hospitals bring testing in house of outsource to large, experienced reference labs?
- NGS industry: Should manufacturers work on smaller actionable panels and affordable instruments in preparation of the coming DECENTRALIZATION of testing, or bet on CENTRAL testing to continue at reference labs and large medical centers (large, high-throughput instruments and panels).
19:05 Close of Day
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THURSDAY, 24 MAY
08:00 Registration and Morning Coffee
08:30 Chairperson’s Remarks
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH, Germany
08:35 Molecular Diagnostics at the Point-of-Care by Centrifugal Microfluidics
Roland Zengerle, PhD, Executive Board Member, Laboratory for MEMS Applications, IMTEK - Department of Microsystems Engineering, University of Freiburg, Germany
Centrifugal microfluidics enables efficient miniaturization, integration, parallelization and automation of biochemical assays in disposable microfluidic cartridges. This talk will demonstrate fully integrated sample-to-answer genotyping assays from whole blood which enable rapid and multiplexed molecular diagnostics of infectious diseases at the point-of-care. Advanced functions will be presented such as splitting a sample into thousands of micro droplets which provide the ground for fast digital assays without the need for calibration.
09:05 POCT and Optics: A Successful Marriage
Francesco Baldini, PhD, Senior Scientist, Institute of Applied Physics “Nello Carrara”, National Research Council, Italy
In recent years, requests by doctors have grown tremendously for devices capable of measuring chemical and biochemical parameters of clinical interest in a reasonably short time that are also sufficiently compact, as to be located near the patient’s bed. In this area, optical biosensors play a fundamental role, allowing the implementation of compact platforms. Moreover, the use of optical fibers can also lead to invasive continuous measurements within the human body.
9:35 In vitro Molecular Point-of-Care Diagnostics for Bacteria Identification
Filipe Arroyo Cardoso, CTO, Magnomics, Portugal
Bacteria identification is becoming a key information to reduce the number of multi-resistant bacteria events. Cell culture has been the gold standard used for this identification. More recently, faster alternatives based on molecular technologies have been developed. The emergence of miniaturization technologies in the market, such as microfluidics and microelectronics, has further enabled molecular point-of-care platforms. This has opened new opportunities in a market that is struggling against bacteria resistance.
10:05 Commercializing Point-Of-Care Diagnostic Solutions
John Carrano, CEO, Paratus Diagnostics, LLC, United States
In his seminal book, The Innovator’s Prescription, business thought leader Clayton Christensen posits that point-of-care diagnostics for infectious diseases will prove one of the key innovations in healthcare delivery in the coming years. And, while we certainly see this already happening for some applications such as rapid flu screening, strep throat, or the testing of urinary tract infections, we still lack high-accuracy multiplexed tests for a wide variety of applications. In some ways, this seems quite surprising given the plethora of novel concepts described in the literature and often the subject of issued patents. Nevertheless, there has been over the past decade a surprising number of POC Dx companies that have completely failed – these are companies that have in some cases burned through tens of millions of dollars and have absolutely nothing to show for it. Why? We believe that there are a set of crucial attributes necessary for the successful commercialization of POC diagnostic solutions; this is the principal subject of our talk. We will use as an example the patent protected PreparedNow® System developed by Paratus Diagnostics of how one can in fact implement an approach for the realization of high-accuracy multiplexed testing for a variety of infectious disease applications.
10:35 Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing
11:20 Cell Function Diagnostics at the Bedside
Mathias Reisbeck, PhD, Postdoc, Chair, Biomedical Electronics, Electrical and Computer Engineering, Technical University Munich, Germany
Point-of-care diagnostics of single cell function requires workflow integration with minimal pre-analytical effort. Magnetic biosensors offer great potential for non-optical read-out with negligible background in optically opaque biological matrices such as whole blood. Here, we present magnetic in-flow detection to probe single cell volume, immunomagnetic binding capacity, and cell morphology. We further integrated this quantitative approach into a credit-card sized cartridge for bedside testing.
11:50 Lab-Disc for Point-of-Care Diagnostics at Resource Limited Settings
Aman Russom, PhD, Associate Professor, Division of Proteomics and Nanobiotechnology, Science for Life Laboratory, Royal Institute of Technology, Sweden
LOC devices are poised to eventually transform the diagnostic methods from laboratory-based to point-of-care (POC) diagnostics systems. Among LOC devices, centrifugal microfluidics platforms carry most capabilities. To this end, we recently modified a DVD player to perform blood tests, including a check for HIV. The breakthrough creates the possibility of an inexpensive and simple-to-use tool that could have far-reaching benefits in health care in low- and middle-income countries.
12:20 MDx and Mass Transport: The Role of Mixing in Molecular Assays
Jay K. Fisher, PhD, Vice President, Engineering, Redbud Labs, Inc., United States
Meeting specifications in POC diagnostics (ex: time-to-result, precision, limit of detection) achievable at the bench is a common challenge, frequently caused by poor mass transport in microfluidic volumes. MXR, Redbud Labs’ easy-to-integrate film for cartridge formats, consisting of hundreds of thousands of microposts for stirring/mixing, makes achieving challenging specifications possible.
12:35 A Robot in A Coffee Pod – An Overview of TTP’s ‘Puck’, a Point-of Care Diagnostics Platform
Piers Harding, C.Eng FIMechE, Mechanical Engineer/Consultant, TTP plc
The past 5 years has seen a wave of new PoC diagnostic platforms entering the market, with intense competition to establish a leading position. Clearly, only a few of the contenders will be successful. At TTP, Europe’s leading independent technology development company, our engineers and molecular biologists have teamed up to create a truly flexible and exceptionally low-cost platform technology: “Puck”. Workflow automation in miniature - find out how Puck stands poised to revolutionise the PoC diagnostics field.
12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
13:20 Session Break
13:50 Chairperson’s Remarks
Daniel Berman, Lead, Longitude Prize, Challenge Prize Centre, Nesta, United Kingdom
14:00 KEYNOTE PRESENTATION: Upcoming New Diagnostic Regulations and How They Will Impact Developers of AMR POC Tests
Doris-Ann Williams, MBE, Chief Executive, British In Vitro Diagnostics Association (BIVDA), United Kingdom
14:20 Innovations in Connectivity in AMR Diagnostics
Rachel McKendry, PhD, Professor, Biomedical Nanotechnology, London Centre for Nanotechnology, United Kingdom
i-sense is an EPSRC-funded Interdisciplinary Research Collaboration that aims to build a new generation of digital sensing systems to identify and prevent outbreaks of infectious disease, much earlier than ever before. We are exploring the use of millions of symptoms reported online each day and building mobile phone-connected tools aimed at widening access to testing, supporting front line health-workers in low and middle-income countries, and people self-testing at home. These tools are designed to be simple to use, cheap to manufacture, and provide rapid and accurate results.
14:40 Developing Assays for Home Monitoring and Management of Patients with COPD
Julie Hart, Head, Diagnostics & Precision Medicine, Strategic & Industry Partnerships, Oxford Academic Health Science Network
COPD is the second most common cause of emergency admissions in the UK, responsible for one in eight (130,000) acute adult medical admissions.The acute and sustained worsening of the symptoms is termed an acute exacerbation of COPD. Mologic has developed two products for patient stratification both based on the use of biomarkers in a multiplex lateral flow format. The first test HeadStart will clearly identify or confirm the first signs of exacerbation with sufficient reliability and clarity for the patient to know when to seek medical attention. The second product is Rightstart, for use by primary care to identify whether to use antibiotics or corticosteroids. Use of RightStart to identify the cause of the exacerbation helps ensure the correct treatment is given and also has the potential to reduce unnecessary antibiotic treatment which supports the UK governments strategies for Antimicrobial Stewardship.
15:00 PANEL DISCUSSION
15:30 Optical Filters for Medical Devices
Georg Draude, General Manager, Chroma Europe, Chroma Technology, Germany
High precision optical filters find usage in classical medical instruments as well as in miniaturized devices. This talk should give an overview on optical applications and instruments used for medical diagnosis and research and the role of state-of-the-art optical filters.
16:00 Refreshment Break in the Foyer
Chairperson’s Remarks
Gyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, United States
16:20 Graphene Biosensor for Early Diagnostics of Ovarian Cancer
Sofia Teixeira, PhD, Research Fellow, Engineering, Swansea University, United Kingdom
The poor prognosis in ovarian cancer (OC) is primarily due to the fact that the majority of women present with extra-ovarian disease, reflecting the absence of major symptoms in the early stages. Importantly, when OC patients are detected at early stages of disease, the prognosis is far more favourable with a 5-year survival rate increasing to over 90%. Here we describe the development and evaluation of a graphene immune-sensor platform, that can be used to detect a range of clinical biomarkers including simultaneous detection of multiple biomarkers which is important in the diagnosis of complex diseases such as OC.
16:50 Epigenetic Immune Cell Profiling - A Novel Approach to Point-of-Care Immune Monitoring
Christoph Sachsenmaier, PhD, Vice President, Strategic Business Development, Epimune GmbH, Germany
Epigenetic immune cell profiling provides a novel approach to molecular immune cell profiling. Using DNA-based, epigenetic markers, immune monitoring can be obtained from minute amounts of fresh or archived clinical samples. Epimune is applying this technology to develop MDx applications in multiple clinical fields like primary immunodeficiency, infectious diseases and cancer.
17:20 Close of Conference
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