NIH Invests For COVID-19 Tests Manufacturing Companies
Even after six months of COVID-19 pandemic, the question remains why there are no faster, cheaper, and better SARS-CoV-2 tests so far. Now the National Institutes of Health (NIH) has agreed to assist some companies in developing their technologies with the hope of overcoming this pandemic crisis. Seven biomedical diagnostic companies will receive $248.7 million in this program. A range of new lab-based and point-of-care tests will receive the support so that the number, type, and availability of tests can be significantly increased by million per week by September 2020.
Francis S. Collins, the Director of NIH, said the initiative called NIH’s Rapid Acceleration of Diagnostics (RADx) has allowed some of the most creative biomedical device inventors in the US to accelerate the development of their technologies at an unexpected speed. The innovations chosen for the investment include the promising technologies that could fulfill the testing requirements of the nation.
The seven companies include start-ups and large publicly-held organizations, whose technologies use different formats and methods in order to meet diverse needs in a variety of settings.
Four of the technologies use technologies like CRISPR, integrated microfluidic chips, and next-generation sequencing to introduce innovations in laboratory-based testing. These technologies could increase the testing capacity dramatically while reducing the time to obtain the results.
Three technologies are for developing viral antigen and nucleic acid tests that can provide faster tests at the point of care, such as manufacturing facilities, nursing homes, offices, schools, and childcare centers. More convenient sampling, such as saliva testing is also offered by some of the tests.
To provide general advice on SARS-CoV-2 test validation and to prioritize the review of emergency use authorization (EUA) for coronavirus tests supported by RADx, the FDA has been working with RADx and NIH. The companies chosen for NIH investment have received EUA from the FDA, or their application is in process.
On April 29, 2020, a few days after the NIH received an emergency supplemental appropriation of $1.5 billion from Congress, it launched the RADx to support technologies that can make millions of rapid coronavirus tests available per week. A nationwide call to most innovative minds in science and engineering was issued by Collins at that time. Over 650 applications were received.
Nearly 100 best concepts were chosen from them by NIH to enter an intense one-week “shark-tank” technology evaluation. Thirty-one projects entered a careful four- to six-week-long validation of initial technology. Among them, even tests were chosen for manufacturing, scale-up, and delivery to the marketplace through RADx. In the coming weeks, 20 companies will be considered for Phase 2 awards in the coming weeks, who remain actively engaged in meeting Phase 1 milestones. More concepts will be selected for Phase 1 and/or Phase 2 funding, as dozens of promising concepts continue to move through the RADx “innovation funnel.”
Bruce J. Tromberg, leader of RADx Tech and director of NIBIB, said the US testing capacity would be increased exponentially in the next few months, he added.
As NIH invests for COVID-19 tests, Mesa Biotech, San Diego, Quidel, San Diego, and Talis Biomedical, Menlo Park, CA will receive support from NIH to manufacture and scale up their point-of-care tests, while Ginkgo Bioworks, Boston, Helix OpCo, San Mateo, CA, Fluidigm, San Francisco, and Mammoth Biosciences, South San Francisco will receive the funding for their lab-based tests.
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