Chairperson: John Sninsky, PhD, Consultant, Translational Sciences

1:00 A Translational Science Perspective of COVID-19 Diagnostic Testing

John Sninsky, PhD, Consultant, Translational Sciences

Only in the last decade has the healthcare community at large appreciated the lack of reproducibility, cost and delayed patient access of an ineffective translational science infrastructure. The urgency of the COVID-19 pandemic brought these shortcomings clearly and abruptly into focus. The lack of understanding of research- and clinical-grade diagnostic tests and the clinically relevant metrics of test performance combined with a near absence of standards has taken a toll.

1:20 Highly Sensitive Crystal Digital PCR Detection Kit for SARS-CoV-2

Romain Parillaud, PhD, International Application Specialist, Stilla Technologies

The current gold standard for COVID-19 diagnosis is based on the detection of SARS-CoV-2 nucleic acid using real-time quantitative PCR (RT-qPCR). Recent studies suggest limitations of RT-qPCR in the detection of SARS-CoV-2, possibly leading to false-negative results. Development of robust and sensitive laboratory tests is of primary importance. Naica™ System is a Digital PCR platform offering absolute quantification of nucleic acids withvery high sensitivity and precision. Based on early and successful proof of concept in China, Stilla is developing a SARS-CoV-2 detection kit on the Naica™ System: a highly sensitive and internally controlled SARS-CoV-2 3-plex. It allows detection of two distinct regions: Nucleocapside (N) and ORF1ab genes of the SARS-CoV-2 positive-strand RNA genome, and an endogenous PCR reference detecting a human housekeeping gene. This single assay design permits the simultaneous detection of two independent SARS-CoV-2 sequences while concurrently monitoring sample PCR effectiveness. Due to its higher sensitivity, Crystal Digital PCR coupled with the detection kit for SARS-CoV-2 should be a perfect alternative to investigate non-conclusive high Ct results obtained in RT-qPCR.

1:40 Diagnostic Test Development for the Emergent Pathogen SARS-CoV-2

Walter H. Koch, PhD, Consultant, Former VP, Head of Global Research, Roche Molecular Systems

The outbreak and rapid global spread of COVID-19 disease demanded widespread testing capabilities to manage and reduce the spread of the contagion. A structured emerging pathogen surveillance and response process combined with an agile assay development approach enabled rapid deployment of a fully automated, high throughout and highly sensitive test for SARS CoV-2.

2:00 FDA Guidance Pathways for COVID-19 Testing

Paul W. Radensky, MD, Partner, McDermott Will & Emery; Principal, McDermott+Consulting

To address the COVID-19 pandemic, the Food and Drug Administration issued new guidance at the end of February and updated in mid-March allowing 4 distinct pathways for COVID-19 detection and serology tests to be released commercially outside the normal FDA clearance and approval pathways. Many tests have been commercialized under these various pathways and many more are expected to be released soon. Some have been released under an Emergency Use Authorization (EUA) from FDA; others have been released without an EUA. Many questions have been raised about these tests, and FDA has maintained a continuously update FAQ website to address many of these questions.

2:20-2:30 Q&A

Speaker Biographies

John Sninsky, PhD
Consultant, Translational Sciences

John J. Sninsky, PhD is a translational medicine consultant with deep understanding of diagnostics and diagnostics paired with medicine intervention. John has served in senior management positions in small and large CLIA service companies and small and large in vitro diagnostic kit companies including Cetus, Roche Molecular Systems, Celera, Quest and CareDx. He was a member of the pioneering Cetus team that developed and optimized PCR technology for research and diagnostic use; specifically, the virology team developed the HIV, HTLV, HPV, HCV and HBV PCR assays. John put in place a surveillance initiative for viral variants and presented at the first FDA PMA advisory meeting for HIV PCR approval.

Romain Parillaud, PhD
International Application Specialist, Stilla Technologies

Romain received his PhD in Neuro-Immunology at Paris VI University, using gene expression analysis on micro-dissected glia cells to determine the role of inflammatory cues in Parkinson Disease mice model. After leading the support of genomics portfolio for Bio-Rad in EMEA, Romain joined our forces as International Application Specialist at Stilla Technologies.

Walter H. Koch, PhD
Consultant, Former VP, Head of Global Research, Roche Molecular Systems

Walter H. Koch, PhD has served as Vice President and Head of Global Research for Roche Molecular Systems from 2005-2020. He was responsible for all research and early development activities, including biomarker discovery and validation, the development of new molecular technologies with diagnostics potential, and expanding the use of real time and digital PCR for clinical applications in the areas of infectious diseases, genetics, Oncology companion diagnostics and “liquid Biopsy” cancer monitoring tests. Prior to joining Roche he held several positions at the US FDA, including Acting Lab Chief of Immunochemistry in CBER’s Division of Transfusion Transmitted Disease. He received a BS in Chemistry from Memphis State University, a PhD in Toxicology and Pharmacology from the University of Tennessee Health Science Center, and was a Postdoctoral Fellow at the Johns Hopkins University School of Hygiene and Public Health.

Paul W. Radensky, MD
Partner, McDermott Will & Emery; Principal, McDermott+Consulting

Paul Radensky, MD is a partner of the law firm of McDermott Will & Emery and a principal of McDermott+Consulting. He is based in the Firm’s Washington, D.C., and Miami offices. Paul is co-chair of the Firm’s Health Services and Medical Products Government Strategies team and a member of the Health Industry Advisory Practice Group. Paul is a Medicare law and policy authority who is board-certified in internal medicine and who helps clients navigate federal legislative and regulatory processes related to Medicare coverage, coding, reimbursement and compliance as well as regulatory and promotional compliance matters with the Food and Drug Administration. Paul represents some of the country’s most innovative developers of pharmaceuticals, biologics, medical devices, and diagnostics before Congress, Health and Human Services, Centers for Medicare and Medicaid, Food & Drug Administration, and other federal agencies.