The New York Academy of Sciences
Understanding COVID-19 Testing
Posted October 26, 2020
The emergence of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), swiftly evolved into a global pandemic in early 2020. With more than 30 million people infected worldwide and almost one million deaths to date, the novel coronavirus continues to wreak havoc on societies across the globe.
Large-scale diagnostic testing is a crucial epidemiological tool for containing the spread of infectious diseases like COVID-19 and is widely viewed as key to safely reopening schools and economies. It is critical to understand who has the disease so that proper medical care, contact tracing, and isolation can be implemented, especially given that 40% of SARS-CoV-2 transmission events occur before the onset of symptoms.
The New York Academy of Sciences hosted a panel discussion that delved into the science behind COVID-19 testing types (e.g., molecular, antigen, serological), as well as the pros and cons of each. Panelists reviewed the real-world applications of these tests. They also asked key questions: What are the current successes and failures of these tests, and what's needed to more safely open schools, return to offices, and engage in other activities? How can testing be better democratized so that all socio-economic sectors have equal access? Innovation is abundant for COVID-19 testing — understanding how the FDA evaluates new COVID-19 diagnostics for regulatory approval or Emergency Use Authorization will also be explored alongside novel ideas for next-generation tests.
In this eBriefing, You'll Learn:
- The different testing types available (e.g., molecular/PCR, rapid/antigen, antibody/serology, pooling), and how each is used in real-world settings.
- Whether testing can facilitate getting us back to work, school, and other activities.
- How the FDA is evaluating new diagnostics and how Emergency Use Authorization (EUA) is being used.
- Next-generation tests that could come to market.
The New York Times
Harvard T.H. Chan School of Public Health
Radcliffe Consulting, Inc
Apoorva Mandavilli, MS
The New York Times
Apoorva Mandavilli is a reporter for The Times, focusing on science and global health. She is the 2019 winner of the Victor Cohn Prize for Excellence in Medical Science Reporting. She is the founding editor in chief of Spectrum, an award-winning news site on autism science that grew an audience of millions. She led the team there for 13 years. She joined The Times in May 2020, after two years as a regular contributor. Apoorva has won numerous awards for her writing. Her work has been published in The Atlantic, Slate, and The New Yorker online, and in the anthology ”Best American Science and Nature Writing.” She co-founded Culture Dish, an organization dedicated to enhancing diversity in science journalism, and was the founding chair of the Diversity Committee for the National Association of Science Writers. Apoorva has a Master of Arts degree in journalism from New York University and a Master of Science degree in biochemistry from the University of Wisconsin-Madison. She is fluent in English, Hindi, Tamil, Telugu, and Kannada.
Michael Mina, MD, PhD
Harvard T.H. Chan School of Public Health
Michael Mina, MD, Ph.D., is a physician-scientist and Assistant Professor in the Department of Epidemiology and Immunology and Infectious Diseases at the Harvard School of Public Health. He is also a pathologist at Brigham and Women's Hospital and Harvard Medical School, where he helps to oversee molecular virology. He is a recent recipient of the National Institutes of Health NIH Director's Early Independence Award, and his public health efforts have been highlighted by The Economist Magazine, where he was named one of eight Global Progress Makers. He has received numerous national and international recognitions for his research on childhood infectious diseases and vaccines. Dr. Mina has been on the front lines of the COVID-19 pandemic since it began, helping to advise state, national, and international institutions and governments and has been instrumental in setting up high throughput COVID-19 testing programs at the Broad Institute of MIT and Harvard, where he is also an Associate Member. His research focuses on monitoring and tracking outbreaks of novel and seasonal viruses through the global population. His laboratory at the Harvard School of Public Health develops new technologies and statistical algorithms that measure the immune system response in fine detail and leverages immunological data to detect and forecast pathogen movement. His clinical work at the Brigham and Women's Hospital is as a medical director overseeing molecular virology diagnostics. Most recently, Dr. Mina is working with colleagues at the Ragon Institute, the MIT Sloan School, and Princeton University to develop a Global Immunological Observatory (GIO) – a not-for-profit network of high throughput laboratories to monitor emerging and existing pathogens in the US and globally. The objective is to create a virus monitoring system that matches the weather forecasting systems in use globally today.
Gail Radcliffe, PhD
Radcliffe Consulting, Inc.
Gail E. Radcliffe has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment and clinical/regulatory issues. Gail founded Radcliffe Consulting in 1998 after having worked at GENE-TRAK, where she developed IVD assays for several infectious disease organisms including HIV, CMV, TB, and Chlamydia, and was responsible for instituting the clinical affairs group. She later joined Cytyc Corporation, where she identified novel applications for the ThinPrep Processor and helped forge partnerships with other health care companies to expand product offerings. As a consultant, Gail has provided assistance to start-up and established medical device companies with regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support. Consulting engagements have encompassed a wide range of products, including cutting edge digital pathology instruments, stem cell laser dissection devices, companion diagnostics, and multiplex molecular, NGS, POC, and CLIA Waived in vitro diagnostic devices. She has been working around the clock with manufacturers and laboratories developing SARS-COV-2 diagnostic products as a regulatory consultant with the RADx program. This program is an NIH funded initiative for the Rapid Acceleration of Diagnostic Products to get everyone back to school and work. Gail obtained a PhD in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. She is a member of the Regulatory Affairs Professional Society (RAPS), American Society of Microbiology (ASM), and Sigma Xi. She is on the Board of Trustees of the Massachusetts Biomedical Initiatives and acts as an advisor to venture capital companies.
Beatus Ofenloch-Haehnle, PhD
Dr. Ofenloch-Haehnle assumed his role as Head of R&D Heterogeneous Immunoassays and System Integration in 1999. His team is responsible for all reagent developments on Roche's Elecsys® immunoassay platform and supports the instrument developments. More than one hundred immunoassays for infectious diseases and other indication areas have been developed during that time. Prior to his current position, he worked for Boehringer Mannheim and Roche in different R&D roles related to protein design and reagent development. Dr. Ofenloch-Haehnle studied Biochemistry and received his PhD from the University of Tübingen, Germany.