Cambridge Healthtech Institute’s 14th Annual

Enabling Point-of-Care Diagnostics

Implementation and Business Strategies

August 25-26, 2020


The field of point-of-care diagnostics is growing exponentially, and the convenience of a rapid response is becoming a necessity. Versatility of POCT spans across home health, remote monitoring, bedside, clinical, pharmaceutical, and field-testing applications. This conference will look beyond technologies and platforms available to the implementation challenges, business solutions, and market access strategies needed for a successful product launch.

Final Agenda

Recommended Short Courses*

SC1: Technologies, Applications and Commercialization of POC Dx

SC4: Accessing Point-of-Care Markets in the US, Europe, and China

*Separate registration required.

TUESDAY, AUGUST 25

7:30 am Registration and Morning Coffee

REDUCING ERRORS AT THE POINT-OF-CARE

8:30 Chairperson’s Opening Remarks

James Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

8:40 Real-World Issues Encountered with POCT

Valerie Ng, MD, PhD, Chair, Department of Laboratory Medicine & Pathology; Laboratory Director, and Director, Transfusion Services, Clinical Laboratories, Alameda Health System

Caregivers expect point-of-care testing (POCT) to be fast and accurate. And, while manufacturers design their POCTs with these goals in mind, real-world testing often defeats the purpose of the best designed POCT system or device. This talk will present real-world vignettes of POCT, highlighting the impact of non-laboratory test personnel, patient care time pressures, and less than orderly environments on POCT devices, their performance, and quality of test results. Suggestions for improved POCT design based on these known real-world pitfalls will be presented.

9:10 Challenges and Practical Solutions in Implementing Point-of-Care Testing

Joseph Wiencek, PhD, Assistant Professor, Department of Pathology; Medical Director, Point-of-Care Testing; Associate Medical Director, Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship, University of Virginia School of Medicine

Point-of-care testing (POCT) is universal in modern healthcare. New and innovative technologies permit diagnostic tests to leave the confines of the centralized laboratory and migrate to the site of patient care. Unfortunately, the excitement of this technology is often lost due to an assortment of practical obstacles. Many of these challenges will be discussed and practical solutions will be offered.

9:40 Risk Management for Point-of-Care Testing

James Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

Point-of-care testing is laboratory testing conducted close to the site of patient care. As tests migrate out of the laboratory, devices are subject to environmental extremes and operator variation that can impact patient results. Errors with point-of-care testing can come from a number of sources, including the instrument, the operator, the reagent, and the environment. Staff need to be cognizant of the probability for error and take actions to prevent and detect errors before they affect results and patient care. Risk management steps through the testing process detecting potential sources for error, then acts through training, maintenance, or the addition of control processes to minimize the potential for errors. This presentation will discuss the common sources of POCT error, describe how manufacturers are engineering their products to prevent errors, and will identify ways that institutions can design their quality control programs to minimize error.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

10:55 Chairperson’s Remarks

James Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

11:00 Let’s Talk about Quality Control & Individualized Quality Control Plans

Jelani Sanaa, MS, MLS (ASCP) CMSBBCM, SHCM, Clinical Laboratory Scientist, Centers for Medicare and Medicaid Services (CMS); Centers for Clinical Standards and Quality (CCSQ); Quality, Safety and Oversight Group (QSOG); Division of Clinical Laboratory Improvement and Quality (DCLIQ)

IQCP provides laboratories with flexibility in customizing quality control (QC) policies and procedures for non-waived testing, based on the test systems in use and the unique aspects of each laboratory. IQCP is voluntary. Laboratories can achieve compliance by following manufacturer’s guidelines and all CLIA QC regulations as written. If those guidelines are less stringent than CLIA, or if the manufacturer does not provide guidelines, the laboratory must implement an IQCP.

11:30 Talk Title to be Announced

Corinne Fantz, PhD, Director, Scientific Affairs, Roche

12:00 pm Talk Title to be Announced

Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.

12:15 Rapid POC Solutions for SARS CoV-2 and Associated Respiratory Pathogens

Claire Huguet, Head, Biomarker Services, Randox Biosciences

Randox is committed to developing infectious syndromic panels to provide precise diagnostics. In collaboration with Bosch, Randox has now released several IVD-quality tests on the POC Vivalytic platform. The latest extended coronavirus 10-plex viral panel detects the SARS-CoV-2 target, MERS, SARS, and 7 other respiratory viruses resulting in similar clinical presentation.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Refreshment Break in the Exhibit Hall with Poster Viewing

PREPARING FOR THE NEXT WAVE OF POC DIAGNOSTICS: OVERCOMING CHALLENGES WITH CONSUMER TESTING

1:30 Chairperson’s Remarks

Lawrence Worden, Founder, Principal, IVD Logix

1:35 Encouraging Innovation: BARDA’s Division of Research, Innovation and Ventures (DRIVe)

Šeila Selimović, PhD, Program Manager, Early Notification to Act, Control, and Treat (ENACT), Division of Research, Innovation, and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS)

The Early Notification to Act, Control and Treat Program within BARDA/DRIVe aims to protect Americans and save lives via pre-symptomatic technology. ENACT seeks pathogen and insult agnostic technologies to identify, characterize, and adapt signatures (biological, biometric, behavioral, and physiological) that can inform on health security threats or exposures prior to symptom onset to facilitate treatment and prevent subsequent cascading effects where possible. We are exploring discovery and validation of biomarkers suitable for non-invasive or minimally invasive collection and other health signatures and tools, empowering individuals to take initial steps to determine health changes that assist clinician care by determining appropriateness of antibiotic vs. antiviral treatment and CBCs from remote settings, including the home.

2:05 Overcoming Regulatory Challenges for Home-Use Tests

Elliot Cowan, PhD, Principal, Partners in Diagnostics

Home-use tests can increase access to testing, safeguard privacy, empower individuals to take control of their healthcare decisions, and protect public health. However, these benefits come with significant risks and challenges, including how to demonstrate that the benefits outweigh the risks, how to address the need for infectious disease reporting, and post-market surveillance. This talk will describe how regulators deal with such issues to bring home-use tests to market.

2:35 Innovative Approaches to At-Home Collection for STI Testing

Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious Diseases, Johns Hopkins University

The iwantthekit (IWTK) program offers internet-requested kits for home collection for screening of common STI. Other programs exist. We will discuss innovation programs and acceptability for home collection, and we will review published programs. Many studies reported use of and willingness to use home collection when available. There was willingness to pay an average of $10-30. User satisfaction was high for home collection.

3:05 Sponsored Presentation (Opportunity Available)

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

PREPARING FOR THE NEXT WAVE OF POC DIAGNOSTICS: OVERCOMING CHALLENGES WITH CONSUMER TESTING (CONT.)

4:25 Chairperson’s Remarks

Lawrence Worden, Founder & Principal, IVD Logix

4:30 Professional Concerns with At-Home Testing

Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns Hopkins University

Currently at-home testing is available in many formats including glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A testing. There are manufacturers who provide the consumer with access to physician care for positive tests and some may even benefit surveillance studies by reporting to local health departments. The ability to give access to testing for those patient populations that may be underserved or underinsured also weigh heavily in the debate of OTC self-testing. Though many arguments support the use of consumer OTC self-testing, there are still some concerns from a quality assurance perspective from the medical technologist who currently oversee point of care testing in the health care setting. In this session, we will discuss some of those concerns from the point of care coordinator’s point of view.

5:00 PANEL DISCUSSION: Overcoming Challenges with Consumer Testing

Moderator: Lawrence Worden, Founder & Principal, IVD Logix

Panelists: Elliot Cowan, PhD, Principal, Partners in Diagnostics

Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious Diseases, Johns Hopkins University

Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns Hopkins University

Šeila Selimović, PhD, Program Manager, Early Notification to Act, Control, and Treat (ENACT), Division of Research, Innovation, and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA), Office of Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS)

5:30 Sponsored Presentation (Opportunity Available)

6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

WEDNESDAY, AUGUST 26

7:15 am Registration

7:30 Problem Solving Breakout Discussions with Continental Breakfast

DEPLOYING POINT-OF-CARE TESTING TO MANAGE DISEASE OUTBREAKS

8:25 Chairperson’s Remarks

Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR); Emeritus Professor, School of Medicine, University of California, Davis

8:30 Geospatial “Hot Spots” Need Rapid Point-of-Care Diagnostics to Stop Highly Infectious Threats and Antimicrobial Resistance

Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR); Emeritus Professor, School of Medicine, University of California, Davis

Increasingly, we observe the adverse personal, societal, economic, and cultural impact of outbreaks, antimicrobial resistance, and disasters. Nations are not prepared! POC strategies can mitigate risk, reduce harm, and improve crisis standards of care. Global solutions integrate national POCT policy and guidelines, and distribute financial burden and reasonable business models.

9:00 Rapid Development of Diagnostic Tests for New Threats: 2019 Novel Coronavirus Pneumonia (COVID-19) and Other Pathogens

Timothy Minogue, Diagnostic Systems Division, United States Army Medical Research Institute of Infectious Diseases

To bridge the gap between rapid point-of-care diagnostics and sequencing, we developed a highly multiplexed assay designed to detect 164 different viruses, bacteria, and parasites using the NanoString nCounter platform. Included in this assay were high-consequence pathogens, such as Ebola virus, highly endemic organisms including several Plasmodium species, and a large number of less prevalent pathogens to ensure a broad coverage of potential human pathogens.

9:30 Point-of-Care Molecular Diagnostics for Disease Outbreak Settings: The Path to the Future

Rachel Spurbeck, PhD, Principal Research Scientist, Health Outcomes and Biotechnology Solutions, Battelle Memorial Institute

Rapid, accurate, and affordable point-of-care (POC) diagnostics are key to detecting and subsequently mitigating the impact of disease outbreaks, particularly for emerging pathogens. Molecular approaches to detection offer speed, sensitivity, and specificity, but can introduce complexity and expense, making it difficult to achieve a POC diagnostic suitable for use outside a clinical setting. This talk will review the current state of the art for molecular diagnostics and examine the path forward to deployable POC diagnostics for outbreak settings, including some of the challenges being undertaken today.

10:00 Presentation to be Announced

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

Plenary Keynote Session

11:30 AM Chairperson’s Remarks

11:35 Diagnostic Technologies that Will Shape Precision Medicine in 2020 and Beyond

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

Precision medicine is being driven by the ability to measure biomarkers at an unprecedented scale. New technologies that enable the measurement of proteomic and genomic signatures, engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging modalities provide personalized profiling that can be used to guide therapies. In order for these technologies to have the greatest benefit, there will need to be profound changes in the entire diagnostics ecosystem.

12:05 PM PANEL DISCUSSION: What Technologies Will Shape Precision Medicine in 2020?

Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center

Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School; Associate Pathologist, Brigham and Women’s Hospital

David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University, HHMI Professor

What is the clinical impact of some of the following technologies and what are the current bottlenecks and challenges that need to be surmounted? Examples of each will be given:

  • RNA sequencing
  • Single-cell sequencing and analysis
  • AI and machine learning
  • Tumor mutational burden measurement
  • Emerging uses of NGS
  • Tumor microenvironment
  • Multi-modality and transcriptomics
  • Microbiome

12: 35 Plenary Keynote Introduction

Charles Mathews, Principal, ClearView Healthcare Partners

12:45-1:15 Fireside Chat

Moderator: Charles Mathews, Principal, ClearView Healthcare Partners

Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration

1:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:45 End of Enabling Point-of-Care Diagnostics

Recommended Dinner Short Course*

SC8: The COVID-19 Case Study: Accelerated Development of Diagnostics for Novel Infectious Disease Threats

*Separate registration required.



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