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That:
in a paper In the New England Journal of Medicine, scientific leaders at the National Institutes of Health laid out a framework to significantly increase the quantity, quality, and type of daily testing for SARS-CoV-2, the virus that causes COVID-19, and help reduce inequities for underserved populations who have been disproportionately affected by the disease. The authors describe the current testing landscape and explain the urgent need to nationally implement low-complexity point-of-care molecular diagnostics with rapid results.
To meet this urgent need, the Rapid Acceleration Diagnostics (RADx) The program was established in just five days after the announcement of $1.5 billion in federal stimulus funding in April 2020. RADx covers the entire lifecycle of targeted testing technologies, focuses closely on timelines and outcomes, welcomes applications from small and large businesses, and has an express focus on health disparities. While based at the NIH, RADx coordinates closely with the Office of the Under Secretary for Health, the Biomedical Advanced Research and Development Authority, and the Department of Defense.
Current testing methods to diagnose COVID-19 detect viral RNA or viral antigens. These tests are very sensitive and specific when performed in centralized laboratories with standardized protocols, but require a large amount of laboratory space, complex equipment, regulatory approvals for laboratory operations, and trained technicians. Results can take hours to days and samples often need to be transported to a central laboratory, compounding delays. During that time, someone who unknowingly carries the virus can infect others, rather than being quickly isolated. These issues highlight the need for rapid and reliable point-of-care diagnostic testing.
RADx includes four main components to enable approximately 6 million daily tests in the United States by December 2020, many times the current daily testing rate. In the short term, RADx addresses the pandemic by expanding testing capacity for fall 2020, as the country faces the onset of the seasonal flu. In the slightly longer term, RADx aims to produce additional innovative diagnostic technologies and strategies to make testing available to diverse, vulnerable and underserved populations.
- RADx Tech aims to identify, accelerate development, scale, and deploy innovative point-of-care technologies during fall 2020. The program uses an “innovation funnel” design where applications rapidly move through multiple stages of review with increasing scrutiny. This has been compared to a “shark tank” model. Approximately 15% to 20% of RADx Tech applications will qualify for additional consideration and review. Of those applications, less than one-third will advance to rigorous Phase 1 testing and validation through the NIH Point-of-Care Technology Research Network (POCTRN). If a project is deemed successful at that point, rapid scale-up and clinical trials are launched, with significant financial assistance. As of July 13, more than 600 applications had been submitted, 27 projects advanced to Phase 1 and one project advanced to Phase 2.
- RADx Advanced Technology Platforms (RADx-ATP) will support the scale-up of more advanced technologies that can achieve substantial and immediate increases in capacity. The program uses a rapid response application process for companies with existing point-of-care technologies authorized by the U.S. Food and Drug Administration to detect SARS-CoV-2 that can scale production to between 20,000 and 100,000 tests per day by the fall. Additionally, RADx-ATP will seek to expand “megalabs” across the country that can increase testing capacity from 100,000 to 250,000 tests per day.
- RADx Radical (RADx-rad) will focus on truly non-traditional testing approaches that have a slightly longer horizon. This program will evaluate a wide range of technologies, such as at-home tests and the repurposing of existing technologies to detect SARS-CoV-2. Additionally, RADx-rad will support projects that use biological or physiological biomarkers to detect an infection or predict the severity of a disease, including the likelihood of developing multisystem inflammatory syndrome in children (MIS-C), or use chemosensory changes as an early indicator of viral positivity. Other examples include using biosensors to detect the presence of the virus in breath or analyzing wastewater for community surveillance.
- RADx Underserved Populations (RADx-UP) will establish community-engaged implementation projects to improve access to testing in vulnerable and underserved populations. Racial and ethnic minorities bear a greater burden of illness and mortality from COVID-19. Blacks, Latinos, and American Indians/Alaska Natives are hospitalized and die at disproportionately higher rates compared to other groups. The goal of RADx-UP is to understand the factors that have led to the disproportionate burden of the pandemic on underserved populations and to support optimal access and uptake of SARS-CoV-2 testing. The program aims to examine infection patterns and efforts to increase access and effectiveness of testing methods by building infrastructure that can be leveraged for ongoing public health efforts against COVID-19.
WHO:
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 comments upon request.
Article:
Tromberg BJ, et al. Rapid Expansion of COVID-19 Diagnostic Testing in the United States: The NIH RADx Initiative. New England Journal of Medicine. DOI: 10.1056/NEJMsr2022263 (2020).
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 that conducts and supports basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures of common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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