As of this week, more than 400 diagnostic tests for COVID-19 and sample collection devices have been authorized by the FDA since the start of the pandemic. Nearly three dozen of those were developed with backing from the National Institutes of Health’s Rapid Acceleration of Diagnostics, or RADx, program—which, even now, is showing no signs of slowing down.
The initiative doled out another $77.7 million to 10 medtech makers currently developing a dozen new testing technologies designed to rapidly detect the coronavirus and, in many cases, other viral infections like respiratory syncytial virus (RSV) and influenza A and B.
The grant winners will use the NIH funds to support development, validation and widescale manufacturing of their diagnostics, with a goal of scoring FDA authorization and making the tests broadly available as soon as this year. They join a roster of 33 other awardees previously selected in the “Shark Tank”-inspired RADx competition, which was established in April 2020 with $1.5 billion in dedicated funds to speed up the creation and distribution of COVID-19 tests.
The newest additions to the list span both at-home and point-of-care diagnostics, with a focus on low-cost tests able to detect multiple respiratory infections within an hour.
BD, for example, received RADx awards for two of its COVID-focused technologies. The first is designed for point-of-care use, with a connected electronic reader delivering results of a lateral flow immunoassay within 15 minutes. The other lateral flow test returns results in the same amount of time, but is meant for home use and is read using a smartphone.
Quidel also snagged a pair of awards from the initiative. One went to a real-time PCR platform intended for use in hospitals and urgent care clinics that can detect COVID, RSV and the flu in less than 25 minutes and could eventually be expanded to test for up to 12 infections at once. Quidel’s other RADx grant went to a combination point-of-care lateral flow test that spots both coronavirus and the flu within 15 minutes.
The other newly NIH-backed technologies include a nanoelectronic biosensor from Palogen that can detect COVID within just three minutes. There’s also a smartphone-connected antigen test from Clip Health that uses glow-in-the-dark nanomaterials to diagnose COVID and the flu in 15 minutes, plus more from Detect, Ellume, LumiraDx, UCLA, Princeton BioMeditech and Uh-Oh Labs, which will hopefully prove its name wrong with the successful deployment of its portable and reusable testing device.
“These technologies represent important innovations to address the need for ready access to rapid, low-cost tests everywhere in the country, including in every home,” said Bruce Tromberg, Ph.D., director of the NIH’s National Institute of Biomedical Imaging and Bioengineering and lead for the RADx Tech segment. “The potential to test simultaneously for multiple types of infection at the point of care is a new frontier that we hope to advance and could be a major step toward transforming U.S. healthcare.”