SARS-CoV-2 Diagnostics Testing: Critical Role in the Pandemic
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hubXchange is proud and delighted to have hosted this webinar on June 3rd. The expert panel, moderated by John Sninsky, explored the challenges of SARS-CoV-2 testing and proposed a few important next steps including:
- Focusing on the logistics of conducting serological tests
- Ramping-up production of lateral flow strips
- Harmonisation of testing protocols and strategies at the Federal level to have consensuson on the sample type being measured
- Build a sufficient national stockpile of swabs and reagents to measure the efficacy of vaccinations
- Comparative evaluations of diagnostic assays as well as confirmatory and neutralisation technologies
- Building panels and blinded panel studies measuring the performance of these tests
- Need for technologies that can simultaneously detect, discriminate and quantify antibodies across the proteome
- Incorporate vaccine-related antigens to discriminate vaccine-induced reactivity from infections and vaccinate people
As the world experiences unprecedented restrictions and confinement due to the SARS-Cov-2 pandemic, diagnostic testing, treatment alternatives and vaccine strategies are equally critical for different reasons. Diagnostic testing has multiple roles: identify infected people, determine efficacy of treatment, suppress local outbreaks through case tracking, identify those who have been exposed and those who may have partial immunity to consider for convalescent sera and efficacy of vaccines.
Set against this backdrop, hubXchange wants to play its part in the fight against SARS-CoV-2 by hosting this free webinar panel discussion to serve as a beacon of clarity for the Life Sciences community. We intend for the webinar to be an unbiased, constructive and informative forum by bringing together a highly experienced group of experts to offer their critique of the existing tests for the various intended uses and collectively address the challenges we continue to face and how we might better prepare for the future.
You can watch to the recording of this webinar below:
Play Video
agenda
Learn more about our agenda
12:00pm Interpretation of Diagnostic Test Results
- What are the roles of direct viral detection and viral exposure (serology) in diagnostic testing?
- What are the most important metrics to consider for comparative diagnostic test performance?
- Tests are available as distributed in vitro diagnostic (IVD) kits and as specific laboratory developed testing services (CLIA). Can you explain the difference and comment on the relative pros and cons of each?
12:20pm Direct Detection of Virus
- What are the challenges of direct SARS-CoV-2 detection?
- What are the regulatory authorized direct SARS-CoV-2 detection tests?
- What are the pros and cons of the available tests?
- Can you comment on the challenges and decisions of the respective regulatory agencies?
- What do you see as the most important next steps?
12:50pm Detection of Viral Exposure (Serology)
- What are the challenges of SARS-CoV-2 serology detection?
- What are the regulatory authorized SARS-CoV-2 serology tests?
- What are the pros and cons of the available tests?
- Can you comment on the challenges and decisions of the respective regulatory agencies?
- What do you see as the most important next steps?
1:20-1:30pm Q&A
PANEL MEMBERS BIOGRAPHIES
Our Expert Panel
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.
Moderator: John SninskyConsultant, Translational Researc
Tom White was VP of Research at Cetus Corporation, where he directed R&D for applications of PCR in basic research, forensics and diagnostics. He subsequently worked for Roche Molecular Systems as Senior VP of R&D and was Senior VP of R&D and Chief Scientific Officer at Celera Corporation. His career involved FDA registration of molecular diagnostic (IVD) products, laboratory developed (CLIA) tests for complex common diseases, and basic research on the molecular evolution of HIV and fungal pathogens. He is a scientific advisor for the Foundation for Innovative New Diagnostics (FIND.org), Global Oncology (globalonc.org), and several biotechnology companies.
Tom WhiteScientific Advisor, FIND; Former Senior Vice President, R&D, Roche Molecular Systems
Maria-Nefeli is currently Director, Scientific & Technical at Mammoth Biosciences. She is a scientist bioengineer with 17 years of R&D experience derisking complicated assay workflows, and delivering microfluidic systems for diagnostics in government, academia, non-profit and industry.
She is a tricultural, quadrilingual science communicator with 50+ talks globally in technical conferences, and invited engagements to both specialist and generalist audiences. She is a co-author of 30+ peer-reviewed publications and co-inventor of 8+ patents in paper-based microfluidics and molecular diagnostics. Maria-Nefeli has a BSc (Hons) degree in Biochemistry and Chemistry and a PhD in Biophysical Chemistry from Southampton University and earned a Postdoctoral Fellowship in Chemistry and Chemical Biology from Harvard University.
Maria-Nefeli TsaloglouDirector, Scientific & Technical, Mammoth Biosciences
Michael Busch earned his MD and PhD degrees at the University of Southern California followed by residency training in Pathology, Laboratory Medicine and Transfusion Medicine at the University of California, San Francisco (UCSF). He is currently Director of Vitalant Research Institute (BSRI) and Senior Vice President for Research and Scientific Affairs at Vitalant, a national network of blood centers and donor testing laboratories. He is also a Professor of Laboratory Medicine at UCSF.
Michael is one of the world’s leading transfusion medicine scientists, well-regarded for his ground-breaking work in such transfusion-transmitted diseases as HIV and West Nile virus and protection of the nation’s blood supply from these and other emerging pathogens. In addition to his leadership as Director of Vitalant Research Institute, Michael is a member of the Transfusion Transmitted Diseases Committee of AABB, the Research and Development Advisory Committee of Canadian Blood Services, President Elect of ISBT (International Society of Blood Transfusion) and several World Health Organization panels.
Michael BuschSenior Vice President, Research & Scientific Affairs, Vitalant; Director, Vitalant Research Institute; Professor, Laboratory Medicine, University of California, San Francisco
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