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Wednesday, July 22, 2020

RADx efforts seek to create capacity for 6 million daily tests by the end of 2020, address underserved populations.

In a paper in the New England Journal of Medicine, scientific leaders from the National Institutes of Health set forth a framework to increase significantly the number, quality and type of daily tests for detecting SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations that have been disproportionally affected by the disease. The authors describe the current testing landscape and explain the urgent need for nationwide deployment of low-complexity, point-of-care molecular diagnostics with rapid results. To fill this urgent need, the Rapid Acceleration of Diagnostics (RADx) program was established in just five days following the announcement of $1.5 billion in federal stimulus funding in April 2020. RADx covers the entire life cycle of the target testing technologies, is tightly focused on timelines and outcomes, receives applications from small and large companies and is expressly focused on health disparities. While based at NIH, RADx is closely coordinating with the Office of the Assistant Secretary for Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense.

Current testing methods to diagnose COVID-19 detect either viral RNA or viral antigens. These tests are highly sensitive and specific when conducted in centralized laboratories with standardized protocols, but require a large amount of lab space, complex equipment, regulatory approvals for the laboratory operations and skilled technicians. Results may take hours to days, and samples often need transport to a central laboratory, furthering delays. During that time someone who is unknowingly carrying the virus may go on to infect others, instead of being quickly isolated. These issues highlight the need for reliable, rapid, point-of-care testing diagnostics.

RADx includes four major components to enable approximately 6 million daily tests in the United States by December 2020, many times the current daily testing rate. In the near term, RADx confronts the pandemic by expanding testing capacity by fall 2020 as the nation faces the beginning of seasonal flu. In the slightly longer-term RADx aims to produce additional innovative diagnostic technologies and strategies for making testing available to diverse, vulnerable and underserved populations.

Tromberg BJ, et al. Rapid scaling up of COVID-19 diagnostic testing in the United-States: the NIHs RADx Initiative. New England Journal of Medicine. DOI: 10.1056/NEJMsr2022263 (2020).

NIH Director Francis S. Collins, M.D., Ph.D., and National Institute of Biomedical Imaging and Bioengineering Director Bruce J. Tromberg, Ph.D., are available to provide comment upon request.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

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NIH leadership details unprecedented initiative to ramp up testing technologies for COVID-19 - National Institutes of Health