2023 Archived Content

Cambridge Healthtech Institute’s 17th Annual

Enabling Point-of-Care Diagnostics

Expediting Rapid Testing for at-Home, Clinical Labs, and Pharmacy Settings

August 21 - 22, 2023 ALL TIMES EDT

The point-of-care industry is poised for tremendous growth and is fueled by both the explosion of enabling technologies as well as the huge need for disruption in the medical sector as consumers demand flexibility and access to testing as well as faster turnaround times. The 17th Annual Enabling Point-of-Care Diagnostics conference has been the cornerstone of the Next Generation Diagnostics Summit and a nexus for industry leaders and start-up innovators to collaborate, partner, and generate novel ideas for both the technologies and the channels bringing them to market. Join us for the exciting forum and learn what is sparking progress and will be materializing for pharmacy, hospital, or at-home testing in the near future.

Scientific Advisory Board
James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology; Medical Director,
Clinical Chemistry and POCT, Vanderbilt University School of Medicine
Lawrence Worden, Founder, Principal, IVD Logix

Sunday, August 20

Registration Open1:00 pm

Monday, August 21

Registration and Morning Coffee7:15 am

8:25 am

Chairperson's Remarks

Lawrence Worden, Founder, Principal, IVD Logix

8:30 am

KEYNOTE PRESENTATION: Home Testing: Data Modernization and Treatment Opportunities

Andrew Weitz, PhD, Program Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB)

The shift of diagnostic testing into the home setting has created new opportunities and challenges for public health surveillance and patient care. This talk will describe how the NIH Rapid Acceleration of Diagnostics (RADx) Tech program is standardizing data capture from home tests and how a positive home test result can enable individuals to access treatments, without having to leave their homes.

9:00 am

Funding and Development Challenges for Novel POCT Technologies

Giles Hamilton

Few novel POCT technologies reach patients who need them. This presentation will look beyond well known capital markets, into supply chain & human resource constraints and provide a "Good, Bad & Ugly" overview.

9:30 am

Regulatory and Clinical Challenges of Getting Novel POCT to Market: Solution-Oriented Approaches

Kristin Robinson, Senior Regulatory Consultant, Clinical Research Solutions, ProPharma

Novel technology development outpaces regulatory bodies which govern marketing approvals, leaving manufacturers scrambling for clear answers on pathway to market. Approaching steep regulatory and clinical validation hurdles is a tenuous experience when regulatory agencies struggle to provide cohesive direction in a new frontier. This presentation explores challenging landscapes staring down IVD manufacturers, discussing risk-based approaches for regulatory strategy and clinical validation to secure solid footing on the road to marketing approval.

9:45 am

Why You Should Care about the Materials in Your Diagnostic Test, and How to Select the Best Materials for Your Assay

Krista Ewing, PhD, Senior Global Product Manager, Porex, Filtration Group

Product developers of in-vitro diagnostics have countless design considerations, from choice of biomarker to assay format. Materials also have an impact on test performance, as appropriate material selection can improve consistency and reduce steps for the end user. Learn how we optimized Porex TruFlow with this in mind and why you should engage with the right material partner from the beginning of development, to ensure test performance and manufacturing ease.

Coffee Break in the Exhibit Hall with Poster Viewing10:00 am

10:45 am

Meeting the Needs for POCT in Low- and Middle-Income Countries

Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting

This talk will include a review of the current situation regarding access to POC diagnostics in LMIC and the main global initiatives aimed at addressing important shortcomings. It will also take a brief look at how trends in access to POC testing in the developed world are finding traction in LMIC and will conclude with a look at challenges and future prospects for POC testing in LMIC.

11:15 am

Advancing Diagnostics to Do What You Can at Home before You Seek Care

Charudutt Shah, Chief Business Officer, Genomtec

Throughout the history of medicine, the default preference has been to do what you can at home, before you seek care or intervention. Diagnostic tests and their results are fundamental to medical decision-making in this very first healthcare pathway. General practitioners (GPs) and other primary care professionals have traditionally had a limited ability to access diagnostic tests directly. Instead, a common model is for GPs to refer patients for laboratory testing. Offering more diagnostic tests in the community could enable faster and earlier diagnosis of common conditions and avoid unnecessary referrals. Additionally, as remote healthcare gathers traction, patients with chronic diseases could get easier access to diagnostic data than ever before. Greater availability of diagnostic testing in primary care is supported by technological, economical, and policy drivers. This talk will present evidence for models of diagnostic service that focus on answering healthcare needs. An attempt will be made to show what’s within reach to reshape care pathways with winning innovative technologies and shift care closer to home.

11:45 am PANEL DISCUSSION:

Diagnostic Testing: Out of the Lab and into the Community

PANEL MODERATOR:

Lawrence Worden, Founder, Principal, IVD Logix

PANELISTS:

Giles Hamilton

Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting

Charudutt Shah, Chief Business Officer, Genomtec

Andrew Weitz, PhD, Program Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB)

12:15 pm

LUNCHEON PRESENTATION:Co-Dx PCR Home: Transforming Infectious Diseases Diagnosis Worldwide

Dwight Egan, CEO, Co-Dx

At Co-Dx, we believe that accurate, affordable, and accessible diagnosis is the first step towards effective treatment of infectious diseases, and in our mission to improve the quality of life of individuals and populations around the world. Co-Dx is revolutionizing community traceability and how diseases are detected at-home and at the point-of-care through its Co-Dx PCR Home platform, designed by world-class engineers and powered by our patented Co-Primers technology.

12:45 pm

LUNCHEON PRESENTATION:truCOLLECT the Next-Generation: Blood Collection, Dry Stabilization and Storage, and Biomarker Retrieval

Ulrich Thomann, Ph.D., Vice President, R&D, Covaris

Covaris developed truCOLLECT, a whole blood collection device, to provide a full Solution starting with small volume (50 µl) blood collection via fingerstick, the transport and long-term storage at ambient temperature and ending with isolated biomarkers. Previously, we have shown that high quality DNA can be isolated from desiccated truCOLLECT blood by applying Adaptive-focused Acoustics (AFA).

Session Break1:15 pm

1:30 pm

Chairperson's Remarks

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

1:35 pm

Personalizing Laboratory Medicine through Mobile Health

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

Mobile health is revolutionizing healthcare, providing patients with more direct access to critical services, personal data tracking, and their own doctors. As the number of applications for smartphones and wearables grows, more people will use them to personalize their own healthcare. This session will explore mobile health technologies and how e-health is transforming the future of laboratory medicine. Data interconnectivity and concerns for privacy, security, and confidentiality will be discussed.

2:05 pm

Direct-to-Consumer Testing and the Future of the Point-of-Care Testing Home Market

Stacy G. Beal, MD, Laboratory Director, LetsGetChecked; Laboratory Director, Kanapaha and Springhill Emergency Department Laboratories, University of Florida, Gainesville

Direct access testing (DAT) is becoming mainstream and will certainly be a crucial part of our healthcare system within this decade. This talk will explore how DAT can provide high quality laboratory testing, while being cost effective, accessible, and comfortable for patients.

2:35 pm

Trends in Mobile Health and Digital Diagnostics

Bernard Gouget, PhD, Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM)

The digital transformation of healthcare can be disruptive. Cutting-edge technologies and accelerating change present both challenges and opportunities. The digital health ecosystem encompasses a variety of technologies and concepts. and will revolutionize the way we deliver healthcare in the coming years. Strong legal and regulatory frameworks are needed to protect the privacy, confidentiality, integrity, and availability of data and the processing of secure personal health data, and to address cybersecurity, trust, accountability and governance, ethics, equity, capacity building, and digital health literacy. Digital technologies will only be effective if they are accessible and useful to as many people as possible.

Refreshment Break in the Exhibit Hall with Poster Viewing3:05 pm

3:45 pm

Regulatory Requirements and Performance Study Design for POC and at-Home Tests

Joen T. Johansen, President & CEO, MDC Associates LLC

The transition of standard of care testing away from the lab toward greater POC and at-home offerings is improving patient access and efficiency in our healthcare systems. The trend in new testing environments, however, presents new regulatory requirements and demonstrating performance of the tests with non-laboratory trained users is paramount to making these tests available to the broader population. This talk will present the regulatory requirements and discuss study design insights for CLIA-waived and at-home (prescription use/over-the-counter) tests.

4:15 pm

Reimbursement of Multiplexing-at-Home with POCT

Angella Charnot-Katsikas, CMO, Palmetto GBA

This session will serve to educate on the reimbursement of tests outlined in L38988, MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing. Included will be a specific discussion of POCTs that may fall within scope of this policy.

4:45 pm

Loop-de-Loop by Scout: A Breakthrough in Multiplexed Nucleic Acid Detection

Cameron Ball, PhD, Founder, Scout

This talk introduces "Loop-de-Loop", an innovative RT-LAMP technology from Scout. Loop-de-Loop's design eliminates the need for specialized consumables or complex manufacturing, promoting easy scalability and cost efficiency. Its portable and durable hardware is suitable for low-resource environments. The presentation also discusses the expansion of Loop-de-Loop to detect other infectious diseases, hereditary conditions, and wellness markers, highlighting its broad potential in diagnostics.

5:00 pm

A Comparison of Cyclo Olefin Polymer vs Other Materials for Life Science Applications

Larry Atupem, Commercial and Business Development Director, COP-Life Sciences,, Zeon Specialty Materials

ZEON SPECIALTY MATERIALS (ZSM) is a wholly owned subsidiary of ZEON CORPORATION, a global world leader in the production of specialty elastomers, polymers, and chemicals. ZEON manufactures ZEONEX and ZEONOR Cyclo Olefin Polymer; an ultra-pure, inert, low-fluorescence polymer with glass-like transparency making them ideal choices for optical, diagnostic and life science devices.

Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing5:15 pm

Close of Day6:30 pm

Tuesday, August 22

Registration Open7:15 am

7:30 amInteractive Discussions with Continental Breakfast

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions page on the conference website for a complete listing of topics and descriptions.

BREAKOUT DISCUSSION:

Getting It Right—The Future of at-Home Diagnostics

Charudutt Shah, Chief Business Officer, Genomtec

Home-based diagnostics enable patients or consumers to conduct different types of tests directly at home. Often these test kits are for known health conditions, can they ALSO be effectively used for diagnosing a previously undiagnosed medical issue?

- What tests/parameters or syndromes are best suited for at-home diagnostics?

- As home testing grows from a nascent trend to an emerging trend – will reimbursement impede patient access?

- How do we ensure that technologies are fool-proof to allow for optimal “do it yourself” testing?

- What are some key success factors for self-testing?

- Successfully managing the retail aspects of “at-home diagnostics”

BREAKOUT DISCUSSION:

Saliva as a Sample Type for the Detection and Surveillance of Respiratory Pathogens

Anne Wyllie, PhD, Research Scientist, Epidemiology, Yale School of Public Health; Principal Investigator, SalivaDirect Initiative

- Evidence in the literature supporting saliva as a reliable sample type for the detection of respiratory pathogens

- Key considerations for working with this non-traditional sample type

- Insights gained from the COVID-19 response: self-collection, sample stability, simplified testing methods

- Reasons to incorporate saliva into your laboratory or surveillance systems, particularly in low-resource settings

8:25 am

Chairperson's Remarks

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

8:30 am

Challenges (and Solutions) to Reimbursement Challenges in Point-of-Care and at-Home Testing

Michael W. Ryan, PhD, Partner, McDermott Will & Emery LLP

Diagnostic testing in the point-of-care and at-home settings creates several regulatory and reimbursement challenges. In this session, we will explore key challenges in market access for these products and walk through strategies for addressing the same.

9:00 am PANEL DISCUSSION:

What Are You Going to Do with This Equipment When COVID Is Gone?

PANEL MODERATOR:

Lawrence Worden, Founder, Principal, IVD Logix

To handle the demand for SARS-CoV-2 PCR testing during the pandemic, laboratory testing capacity had to be rapidly expanded resulting in a major expansion in the installed base of molecular analyzers. Due to both volume requirements and supply chain issues some laboratories were using as many as 8 to 10 different platforms for SARS-CoV-2 testing at the height of the pandemic. This panel will explore what diagnostics were acquired, what is still in use, and how this excess capacity is likely to affect future acquisitions.

PANELISTS:

Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology; Medical Director, Medical College of Wisconsin

Gregory J. Tsongalis, PhD, Vice Chair Research & Director & Professor, Pathology & Lab Medicine, Dartmouth Hitchcock Medical Center

10:00 am

Reaching the Hard-To-Reach at Scale

Rafid Fadul, Primary.Health Medical CEO, Primary.Health

Innovations in diagnostics have created new screening and diagnosis solutions. However, we are still falling short. Undiagnosed rates for kidney disease, HIV, and colorectal cancer remain high, with known disparities. How do we reach the promise of decentralized diagnosis and care? This talk shares our experience in enabling diagnostic devices and labs to reach the hard-to-reach at scale, emphasizing cost-effective solutions and clear pathways to treatment.

Coffee Break in the Exhibit Hall with Poster Viewing10:30 am

11:30 am PLENARY PANEL DISCUSSION:

Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care

PANEL MODERATOR:

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

Many oncology patients who are eligible to receive high-value personalized treatments do not. Despite a lengthy history of targeted treatment availability in advanced non-small cell lung cancer (aNSCLC), a recent study found that 644 of every 1,000 newly diagnosed aNSCLC patients (64.4%) did not receive a personalized treatment due to clinical practice gaps in the delivery of precision oncology.

What are the clinical practice and policy challenges related to diagnostic testing and the delivery of appropriate targeted therapies leading to a failure of patients to receive precision oncology strategies?
What impact does each clinical practice gap have on the population-level delivery of precision oncology?
How can we optimize biomarker testing and treatment decision-making to help best address clinical practice gaps?
What policies and practices can help assure optimal and equitable delivery of appropriate high-value personalized medicines?

PANELISTS:

Robert H. Dumanois, Director, Reimbursement Strategy, Thermo Fisher Scientific

Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo@Lilly

Apostolia-Maria Tsimberidou, MD, PhD, FASCO, FAASS, Professor of Medicine, Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center

12:30 pm

LUNCHEON PRESENTATION:Inception to Engineering: How to Develop a Lateral Flow with an External Partner

Jackie Day, Senior Commercial Project Manager, Life Science | DxRM, MilliporeSigma

You have an idea for a point-of-care assay that can help customers and patients; all that’s left is developing a product! Through a real-life case-study, we will illustrate the typical processes involved in developing a lateral flow test with an external partner. From ideation to commercialization, we will discuss key steps that can shorten time to market and reduce costs while delivering robust results.

Close of Enabling Point-of-Care Diagnostics Conference1:30 pm