Point-of-Care Diagnostics

Cambridge Healthtech Institute's Third Annual

Point-of-Care Diagnostics

( 定点照护诊断 )

Meeting the Demand for Rapid Results and Improved Outcomes

2018年5月23-24日 | Sheraton Lisboa Hotel & Spa| 葡萄牙,里斯本

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 develped 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


Recommended Short Course*

SC1: Technologies, Applications and Commercialization of Point-of-Care Diagnostics

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

plenary session

11:35 Plenary Introduction

John Carrano, CEO, Paratus Diagnostics, LLC, United States

11:45 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 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

Jorg 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, TUV SUD, 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

DIGITAL HEALTH AND HOSPITAL 4.0: THE ROLE OF POCT IN A DIGITALIZED CONTINUUM OF CARE

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_EiffWilfried 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_ButtigiegSandra 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_HoofJoost van Hoof, PhD, MSc, Eur Ing, Head of Fontys EGT, The Centre for Healthcare & Technology, Fontys 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_AbelGyorgy 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_SteinhauserStefanie 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_PeulingSarah 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

19:05 Close of Day

THURSDAY, 24 MAY

FULLY INTEGRATED DIAGNOSTIC DEVICES

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_ZengerleRoland 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_BaldiniFrancesco 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 Talk Title to Be Announced

John Carrano, CEO, Paratus Diagnostics, LLC, United States

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

11:20 Cell Function Diagnostics at the Bedside

Mathias_ReisbeckMathias 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

12:35 Sponsored Presentation (Opportunity Available)

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

13:20 Session Break

POCT FOR ANTI-MICROBIAL STEWARDSHIP

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

14:40 Rapid Smartphone Based Diagnostics to Aid in Appropriate Antibiotic Use

Patrick_DunlopPatrick Dunlop, PhD, Senior Lecturer, Course Director, Engineering Science, Chair NI AMR Network, Nanotechnology and Integrated BioEngineering Centre, School of Engineering, Ulster University, United Kingdom

There is considerable interest in the development of rapid and portable diagnostic systems to help prevent the inappropriate use and prescription of antibiotics. This presentation will discuss the development of low-cost smartphone based diagnostic systems, combining patient information (history and symptoms) with a range of biomarker tests, and will highlight the importance of user-centered design and implementation of user feedback throughout the development cycle.

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

IS THERE A ROLE FOR RAPID TESTING IN CANCER DIAGNOSTICS AND MONITORING?

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_TexeiraSofia 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

* 活动内容有可能不事先告知作更动及调整。