Interactive Discussions

TUESDAY, AUGUST 22 at 7:30 AM

Enabling Point-of-Care Diagnostics

Table 1: 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 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”​

Table 2: 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

ADVANCING NOVEL FRAMEWORKS FOR COMPANION DIAGNOSTICS

Table 3: Putting Together a Wishlist for Alternative US FDA CDx Regulations
Dun Liang, PhD, Executive Director, Regulatory Affairs, Companion Diagnostics, Loxo@Lilly

• What are the major challenges and pain points within the current CDx regulatory framework?
• Will the proposed FDA/OCE CDx pilot program effectively address the existing pain points?
• What practical aspects should the CDx pilot program consider to improve patient access to testing while ensuring reliability and accuracy?

Liquid Biopsy for Disease Management

Table 5: MCED vs Single Organ Detection: Pros and Cons of Each
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group, National Cancer Institute (NCI), NIH

• Cost-effectiveness
• Post-test decision-making
• Patient compliance
• Rare cancer detections

WEDNESDAY, AUGUST 23 AT 7:30 am

Advanced Diagnostics for Infectious Disease

Table 1: FDA Update
Albine K. Martin, PhD, Executive-in-Residence, BioHealth Innovation; Entrepreneur-in-Residence, Johns Hopkins University
Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.

• EUA to 510(k) transition
• OTC test requirements
• Multiplex assays
• IVD clinical study designs
• Overlapping regulatory strategy with the business case

Table 2: 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

Emerging Trends in Coverage and Reimbursement for Advanced Diagnostics

Table 3: The Role of Government Reimbursement in Encouraging (or Discouraging) Innovation in Diagnostic Testing
John F. Warren, Owner, Gettysburg Healthcare Consultants

• Diagnostic technology continues to evolve, but government reimbursement policies have not fundamentally changed since the 1990s. To what extent should we question the viability and effectiveness of employing policies that were formulated three decades ago in a market that is constantly undergoing rapid transformations?
• In what ways can government reimbursement strategies for diagnostic testing be optimized to strike a balance between incentivizing innovation and ensuring accessibility and affordability for patients, considering the evolving nature of healthcare technologies and the need for continuous advancements in diagnostic capabilities?
• What potential consequences could arise from either encouraging or discouraging innovation through updated reimbursement policies?

• Leveraging key opportunities and tackling challenges for coverage & reimbursement
• Capitalizing on recent successes
• Determining expectations for new Genomic Sequencing Procedure CPT Codes

Early Cancer Surveillance

Table 5: Pre-Competitive Collaboration for Early Cancer Detection
Lauren Leiman, Executive Director, BLOODPAC Consortium
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group, National Cancer Institute (NCI), NIH

• Opportunities for pre-competitive collaboration                
• Examples of current collaborative efforts                
• Challenges for commercial and non-commercial organizations

Table 6: Congressional Legislation to Facilitate Medicare Coverage of MCEDs
Jonathan Cohen, President & CEO, 20/20 GeneSystems
Stephen Ezell, Vice President, Global Innovation Policy, ITIF IT & Innovation Foundation

• Validation clinical trials for early detection could still take years                
• Legislative efforts to promote or require coverage could be a game-changer   
• Update on current and potential legislative initiatives

Table 7: Differing Strategies; First Targeting Higher-Risk Patients or General Population Screening
Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC
Sudhir Srivastava, PhD, Chief, Cancer Biomarkers Research Group, NIH NCI

• Algorithms for analysis are undergoing constant revision and improvement
• The end goal should be MCEDs that can be used in the general population
• Should testing in higher-risk cohorts be a stepping stone to broader general use?

Decentralized POC Testing

Table 8: Looking into the Future of Point-of-Care and OTC Testing
Jordan S. Laser, MD, Principal and Founder, Laser Laboratory Consulting

• What are some current trends you are seeing in the point-of-care space?
• In a post-pandemic world, is the push to OTC still progressing, or has it slowed down?
• What are the next big diagnostics to hit the point-of-care market?​​

Table 9: Taking a Closer Look at Novel and Upcoming Point-of-Care Testing and Interpretation
Maikel Boot, PhD, Technical Director, PreScouter, Inc.

• The use of AI/algorithms for results interpretation on point-of-care devices
• ​Reagent-free point-of-care diagnostics
• New biosensors (e.g., graphene-based)
• At-home sample collection, mail-in vs. at-home testing: which one is the future?