September 20, 2022 | The National Institutes of Health (NIH) seeks to award up to $300 million to diagnostic test manufacturers for developing improved next-generation COVID-19 tests. The funds will be managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and awarded as a part of the Rapid Acceleration of Diagnostics (RADx) Tech program. RADx was launched in April 2020 to provide regulatory guidance in diagnostic testing manufacturing and increase the speed and use of COVID-19 testing technologies.
The funds will generate from the American Rescue Plan Act of 2021, a bill designed to address the prolonged impact of COVID-19 on the general public, various institutions, and governing bodies.
Funds will be allocated to manufacturers based on two main objectives: performance and accessibility. “The number one challenge now is to raise the game on accessibility. The first of two innovation funnels we’ve just announced is test design for independent use of at-home tests by people with disabilities. In the other, we are after better-than-current best-in-class technologies,” Bruce Tromberg, Ph.D., NIBIB director and lead for the RADx® Tech program, tells Diagnostic World News.
Over-the-counter and point-of-care tests should be user-friendly, contain universal design features, and function irrespective of variant without serial or subsequent testing. Additionally, all eligible products must be released to market within 24 to 36 months.
Over-the-counter tests must also be accessible for patients with low vision or blindness, a lack of fine motor skills, and other challenges associated with aging. Products in this category should be ready for market within 12 to 24 months.
Over the past two years, the United States has seen tremendous progress in increasing COVID-19 testing while simultaneously abbreviating production timelines to span months rather than years.
“Many well-established at-home test designs were able to be developed quickly and disseminated widely given the urgent needs presented by the pandemic—and we are pleased that in a short period of time, we have enabled billions of tests and test products to be manufactured to meet needs in this country,” adds Tromberg.
This initiative aims to capitalize on previous gains by meeting the ongoing needs of some of the nation’s most vulnerable patients. The NIH will begin accepting applications on September 20, 2022.