Cambridge Healthtech Instituteの第17回年次会議
Enabling Point-of-Care Diagnostics
2023年8月21 - 22日、EDT（米国東部標準時）
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
Registration and Morning Coffee7:15 am
DIAGNOSTIC TESTING: OUT OF THE LAB AND INTO THE COMMUNITY
KEYNOTE PRESENTATION: Home Testing: Data Modernization and Treatment Opportunities
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.
Funding and Development Challenges for Novel POCT Technologies
Meeting the Needs for POCT in Low- and Middle-Income Countries
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.
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.
Product developers of in vitro diagnostics have countless design considerations, from choice of biomarker to final assay format. Materials can seem minor in comparison but can have a huge impact on test performance. Appropriate material selection can improve consistency of analyte detection and reduce steps for the end user. Learn why you should engage with the right material partner from the beginning of development, to ensure both test performance and manufacturing ease.
Coffee Break in the Exhibit Hall with Poster Viewing10:00 am
Advancing Diagnostics to Do What You Can at Home before You Seek Care
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 with evidence for models of diagnostic service that focuses 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.
The Future of at-Home Diagnostic Testing and Pandemic Preparedness
COVID-19 was the first time, outside of pregnancy tests, where diagnostic tests truly became a household item. Now, people want access to more information, faster, putting them in greater control of their health. The first HIV self-test took a decade to become available in the U.S., the first COVID self-test took roughly a year. What is the future of at-home testing? Learn from Abbott about the challenges, opportunities, and possibilities in technologies that are being developed to bring this tech to life while also working to respond quickly to new viruses in the future through an industry-led global partnership.
Session Break1:15 pm
HOME-TESTING AND MOBILE HEALTH DIAGNOSTICS
Personalizing Laboratory Medicine through Mobile Health
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.
Direct-to-Consumer Testing and the Future of the Point-of-Care Testing Home Market
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.
Trends in Mobile Health and Digital Diagnostics
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
Regulatory Requirements and Performance Study Design for POC and at-Home Tests
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.
Reimbursement of Multiplexing-at-Home with POCT
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.
Presentation to be Announced4:45 pm
Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing5:15 pm
Close of Day6:30 pm
Registration Open7:15 am
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.
Getting It Right - The Future of at-Home Diagnostics
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 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”
Saliva as a Sample Type for the Detection and Surveillance of Respiratory Pathogens
- 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
WHAT'S NEXT FOR POCT?
Challenges (and Solutions) to Reimbursement Challenges in Point-of-Care and at-Home Testing
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.
What Are You Going to Do with This Equipment When COVID Is Gone?
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.
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
Transition to Plenary Panel Discussion11:15 am
PLENARY SESSION Co-Organized by PMC
Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care
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?
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.
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:00 pm
Close of Enabling Point-of-Care Diagnostics Conference1:30 pm
Recommended Dinner Short Course6:00 pm
SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward
*Separate registration required. See short courses page for details.