Interactive Discussions

Tuesday, August 23 at 7:30 am

Enabling Point-of-Care Diagnostics

TABLE 1: At-Home Testing: An Inflection Point for Adoption and Utility
Jordan S. Laser, MD, Chief Laboratory Officer, Everly Health
The pandemic has catapulted at-home testing 10 years into the future.  The entire nation has essentially experienced a 2-year training session on at-home collection and at-home diagnostics.  Beyond the experience, the general population has realized the quality, convenience and value of at home testing.  This talk will explore the widespread adoption of at home testing/telehealth care, the impact on outcomes as well as state government adoption.

Drug Diagnostic Co-Development and Companion Diagnostics

TABLE 2: The Benefit-Risk Considerations for Early Adoption of IVD Validation in Co-Development (Drug and CDx) Paradigm
Jai Pandey, PhD, Director, Global Regulatory Strategy IVD, Bayer HealthCare

  • What are some potential benefits of adoption of validated IVD in early phase of co-development trials?
  • What are some potential challenges to early adoption of IVD validation in oncology therapeutic trials? 
  • Does evolving regulatory landscape across the globe could reshape the use of IVD in early phase of co-development trials?

Liquid Biopsy for Disease Management

TABLE 3: Bringing Liquid Biopsy into Early Cancer Detection
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research Group, National Cancer Institute (NCI), NIH
What are the greatest impediments to bringing liquid biopsy technologies into the early cancer detection space?

  • How can we overcome the low levels of target analytes, low limit of detection, etc.?
  • What can be done to improve specificity, sensitivity, and precision?
  • Is artificial intelligence/machine learning the next step to validation?
  • Is liquid biopsy cost-effective in the early cancer space? How does insurance reimbursement play into this issue?
  • What are the advantages/disadvantages of MCED (multicancer early detection) technologies?

TABLE 4: Regulatory Requirements for IVDs and RADx Insights
Gail Radcliffe, President, Gail Radcliffe Consulting Inc.

Wednesday August 24 at 7:30 am

Advanced Diagnostics for Infectious Disease

TABLE 4: Diagnostic Stewardship for Management of Point-of-Care Testing
Erin McElvania, PhD, D(ABMM), Director of Clinical Microbiology, NorthShore University HealthSystem

  • What are some examples of when diagnostic stewardship can be helpful and when it can be harmful?
  • Who is in charge of diagnostic stewardship for point-of-care testing at your institution?
  • What are some successful stewardship strategies that have worked at your institution and why?
  • What are some strategies that didn't work and why?

Coverage and Reimbursement for Advanced Diagnostics

TABLE 5: Reimbursement of Genomic Profiling in Oncology – Best Practices 
Gillian Hooker, PhD, CSO, Concert Genetics

  • What are the key challenges and opportunities for genomic profiling related to coverage and reimbursement? 
  • How to achieve value-based market access and reimbursement: Key best practices

TABLE 6: Reimbursement Process for New Genomic Technologies
Megan Anderson Brooks, PhD, Principal, Innovation Policy Solutions LLC

  • How does the medical policy process work?
  • Is there a standard definition of clinical utility?
  • Do technology assessment companies influence medical policy decisions?


TABLE 7: MCED Disruption and Health Economic Implications
Moderator: Samir Hanash, MD Anderson

  • What would be the impact of widespread adoption of MCED screening on current screening modalities for cancer?
  • What are implications for addressing access, costs and follow-up requirements?
  • What other health economic implications need to be considered?

TABLE 8: Sequencing of DNA as Early Cancer Biomarkers
Co-Moderators: Sudhir Srivastava, National Cancer Institute, and Nicholas C. Dracopoli, PhD, CSO, Delfi Diagnostics

  • Pros and Cons of DNA, methylated DNA or combinations for early detection
  • Considerations of cost for sequence-based early detection biomarkers
  • Follow-up requirements for DNA-based biomarker tests