Diagnostic Landscape
for COVID-19

Watch Trailer

Final Program

Thursday, June 18, 2020

 

  • 10:00 AM

Organizer’s Opening Remarks

Emily Le, PhD, Founder & CEO, Bioinsider

  • 10:05

Program Chairperson’s Opening Remarks

Karl V. Voelkerding, MD, Professor, Pathology, University of Utah; Medical Director for Genomics and Bioinformatics, ARUP Laboratories

  • 10:10

Comparing Diagnostic Methods for COVID-19: Practical and Statistical Considerations

Timothy J. O’Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs

Performance comparisons among diagnostic tests require attention to timing, ease, and appropriateness of use, sensitivity, and specificity. The talk will address points to consider when evaluating literature making such comparisons, as well as practical and statistical considerations that should inform diagnostic device comparisons.

  • 10:35

Multiplatform Comparisons of Molecular Tests for COVID-19: Predicting Differences in Case Detection

David Hillyard, MD, Medical Director, Molecular Infectious Diseases; Professor, University of Utah School of Medicine

This talk will summarize current methods used to determine the analytic sensitivity of EUA approved COVID-19 tests and approaches to determine the impact of test sensitivity on case detection.

  • 10:55

The Critical Role of Antigens in COVID-19 Serological Test Development

Teng Peng, PhD, Technical Application Manager, ACROBiosystems

High-quality recombinant SARS-CoV-2 antigens play an essential role for the development of antibody test kits. The selection of construct and expression host cell are key determinants in producing antigen proteins with high bioactivity and batch-to-batch consistency. Optimization of constructs and screening of expression host cell can lead to suitable antigens for serological test development.

  • 11:05

Speed Networking

All attendees are welcomed to turn on video and audio to interact with others

  • 11:25

Session Break

  • 11:35

Development, Implementation, and Regulation of Diagnostic Methods at the State Level – New York Perspective

Kirsten St. George, PhD, Director, Virology Laboratory; Chief, Viral Diseases, Wadsworth Center; Clinical Professor, School of Public Health, Biomedical Sciences, SUNY 

From the earliest days of diagnostic testing and initial emergency use authorizations, through current day challenges of large-scale screening of health care personnel and patients, the COVID-19 pandemic has presented unprecedented challenges to all laboratories. This presentation will provide an overview of experiences at the New York state public health laboratory including diagnostic, regulatory, and research response efforts.  

  • 12:00 PM

Development and Scaling of the LabCorp COVID-19 RT-PCR Test

Brian Krueger, Associate Vice President, Technical Director, R&D at LabCorp

LabCorp was the first commercial diagnostics company to receive emergency use authorization for COVID-19 RT-PCR testing and at-home collection of COVID-19 samples. Development began in late January and culminated with the at-home collection approval on April 20, 2020. LabCorp has since scaled its PCR testing operation to over 100,000 samples per day with a turnaround time of 1-2 days.

  • 12:25

Speed Networking

All attendees are welcomed to turn on video and audio to interact with others 

  • 12:45

Session Break

  • 1:30

The Rapidly Evolving Role of Antibody Testing for SARS CoV-2

Co-presenter: Patricia Slev, D(ABCC), Section Chief Immunology Division, Medical Director Core Immunology; Medical Director Microbial Immunology, Medical Director Serologic Hepatitis and Retrovirus Laboratory; Associate Professor, Pathology, University of Utah

Co-presenter: Elitza Theel, PhD, Associate Professor, Laboratory Medicine, and Pathology, Mayo Clinics

Serology testing for SARS CoV-2 is now available on a number of platforms and more are receiving approval each day. This presentation will provide an overview of the current assays, including appropriate use of the different methodologies for antibody testing, clinical utility, and result interpretation.

  • 1:55

Interpretation of COVID-19 Diagnostic Test Results: A Clinician’s Perspective

Ralph Rogers, MD, Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University

The rapidly expanding number of diverse SARS-CoV-2 molecular and serologic tests now available to clinician’s paired with the disparate performance characteristics of various assays may lead to challenges when interpreting test results. This case-based presentation will explore the limitations of currently available diagnostics in various clinical scenarios, and will highlight important factors to consider when ordering and interpreting these tests.

  • 2:20

Session Break

  • 2:30

Home Collection of Nasal Specimens – Lowering the Barrier to SARS-CoV-2 Testing and Expanding Access to Care

Karen A. Heichman, PhD, Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation

Diagnostic testing for SARS-CoV-2 remains a challenge today, even after several weeks and with the emergence of a number of innovations. In the first weeks of the epidemic in the US, it became clear that even specimen collection was severely limited by shortages in NP swabs, viral transport media, medical personnel to collect specimens and PPE to prevent the exposure of healthcare works while collecting specimens. The knowledge that a simple nasal swab made of spun polyester, which may be manufactured inexpensively and at high capacity, together with the finding that a swab may be stably stored and transported to the lab for testing in a dry tube, without cold chain, has lowered the barrier to specimen collection and is enabling for self-collection in the home or workplace. We believe that a pre-positioned home collection kit, comprised of a polyester nasal swab, a simple tube and collection instructions, could dramatically broaden the access to SARS-CoV-2 testing in both the developed world as well as in low and middle income countries.

  • 2:45

Closing Panel Discussion: Considerations for All Tests and How to Properly Handle the Pandemic with the Current Testing Capacity

Moderator: Karl V. Voelkerding, MD, Professor, Pathology, University of Utah; Medical Director for Genomics and Bioinformatics, ARUP Laboratories

Panelists: Karen A. Heichman, PhD, Senior Program Officer, Diagnostic Development, Innovative Technology Solutions, Global Health Division, Bill & Melinda Gates Foundation

Yuan-Po Tu, DVM, MD, Urgent Care Physician, Medical Director, Flu Services, Anticoagulation, Epic Provider Efficiency, The Everett Clinic-Part of Optum

Ralph Rogers, MD, Assistant Professor of Medicine, Clinician Educator, Infectious Diseases, Warren Alpert Medical School of Brown University

Brian Krueger, Associate Vice President, Technical Director, R&D at LabCorp

Timothy J. O’Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland School of Medicine; Former Chief Research and Development Officer, Veterans Affairs

  • What are the current bottlenecks in the supply chain for the provision of molecular and serologic testing?
  • What is the current testing capacity nationwide or is it more relevant to assess testing capacity per geographic location?
  • Have any regional testing consortium been organized?
  • What proportion of molecular testing is currently being performed in public health laboratories?
  • What locations in the country are leaders in testing and contact tracing?
  • What will be the role of serologic testing when a vaccine is available? Will it be feasible to test individuals who have been vaccinated to determine if they have become seropositive?
  • 3:15

End of Main Event and Transition to Breakout Discussion

  • 3:30 - 4:30

Breakout Discussion

Join our 1-hour breakout discussions for face time with our speakers and your peers. These are informal, moderated discussions featuring brainstorming and interactive problem solving—allowing participants from diverse backgrounds to exchange ideas and experiences, and develop future collaborations around a focused topic. In order to ensure effective discussion, breakout discussions will have a maximum of 10-15 attendees per room and are on a first-come, first-served basis.

Breakout Room 1: Translational Diagnostic Pipelines: Pre-clinical and Clinical Best Practices

Moderator: John Sninsky, Consultant, Translational Sciences

  • Balancing diagnostic, therapeutic and vaccine development
  • Best practices and key regulatory guidance for translational diagnostics
  • Comparative diagnostic performance metrics

Breakout Room 2: Biomarkers to Predict Severe COVID-19 and Clinical Considerations When Testing for SARS-CoV-2

Co-Moderator: Sam Ali, PhD, Strategic Partnerships and Ventures at Denka Corporation

Co-Moderator: Yuan-Po Tu, DVM, MDUrgent Care PhysicianMedical Director, Flu Services, Anticoagulation, Epic Provider EfficiencyThe Everett Clinic-Part of Optum

  • Why do some patients exhibit severe disease manifestation?
  • Discovering predictive severity biomarkers
  • Strategies for applying mass screening for predicting severe COVID-19 patients
  • Timing and selection of SARS-CoV-2 tests
  • Optimizing specimen collection for diagnostic testing
  • Alternative options when facing swab and transport media shortages

Breakout Room 3: What We Know About Serology Testing

Moderator: Patricia Slev, D(ABCC), Section Chief Immunology Division, Medical Director Core Immunology; Medical Director Microbial Immunology, Medical Director Serologic Hepatitis and Retrovirus Laboratory; Associate Professor, Pathology, University of Utah

  • Best practices for serology testing
  • Serology testing applications
  • The science behind antibody testing

Breakout Room 4: Ongoing Challenges with COVID-19 Diagnostics

Moderator: Kirsten St. George, PhD, Director, Virology Laboratory; Chief, Viral Diseases, Wadsworth Center; Clinical Professor, School of Public Health, Biomedical Sciences, SUNY

  • What is the situation with antigen testing?
  • Do we still need more molecular assays or platforms?
  • Is there any role for culture and does it really need BSL-3?
  • The elephant in the room – the authorization of tests

Breakout Room 5: Rapid Testing

Moderator: Timothy J. O’Leary, MD, PhD, Adjunct Professor, Pathology, University of Maryland
School of Medicine; Former Chief Research and Development Officer, Veterans Affairs

  • How do we most effectively use rapid diagnostic tests, such as ID NOW and Xpert/Xpress, in the emergency room setting?
  • Is there a role for rapid diagnostic testing in surveillance of Covid19-facing healthcare personnel?
  • What, if any, is the best way to use lateral flow serologic testing in dealing with the Covid-19 pandemic.
  • 4:30

End of Diagnostic Landscape for COVID-19

-THANK YOU-

Speakers & Moderators

Sam Ali, PhD

Kirsten St. George, PhD

Karen A. Heichman, PhD

David Hillyard, MD

Brian Krueger, PhD

Timothy J. O’Leary, MD, PhD

Teng Peng, PhD

Ralph Rogers, MD

Patricia Slev, D(ABCC)

John Sninsky, PhD

Elitza Theel, PhD

Yuan-Po Tu, DVM, MD

Karl V. Voelkerding, MD