11:00 Chairperson's Remarks
Chairperson to be Announced
11:05 Ultrasensitive SARS-CoV-2 Protein Assays for Precision Clinical Decisions
David Walt, PhD, HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School;
Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University
We have developed ultrasensitive single molecule assays for multiple relevant SAR-CoV-2 proteins that can detect both active virus and prior infection. The assays have been tested in thousands of individuals, including patients and healthcare workers
and exhibit exceptional sensitivity and specificity. Additionally, we have followed these protein concentrations over time during the course of disease in many patients and can predict outcomes based on the dynamics of the protein responses.
11:30 Lessons Learned for Diagnostic Testing During the COVID-19 Pandemic
PANEL MODERATOR:
Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center
- Supply chain challenges
- Navigating and validating multiple platforms
- Reimbursement
- Value of distributed testing
- Value of tests available: PCR vs. antigen vs. serology
- Developing sustainable testing protocols
PANELISTS:
Alex Greninger, MD, PhD, MS, MPhil, Assistant Professor, Lab Medicine, University of Washington
Jordan S. Laser, MD, Medical Director, Department of Pathology and Laboratory Medicine; LIJMC Associate Medical Director,
Core Laboratories; Sr. Director, Division of Cytogenetics and Molecular Pathology; Director, Division of Near Patient Testing, Northwell Health
David Walt, PhD, HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical
School; Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University
12:05 pm Keynote Introduction
Charles Mathews, Principal, ClearView Healthcare Partners
12:20 Fireside Chat
PANEL MODERATOR:
Charles Mathews, Principal, ClearView Healthcare Partners
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PANELIST:
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