NEW YORK – The US National Institutes of Health announced on Monday that it has awarded $29.3 million in new contracts to diagnostic firms to increase SARS-CoV-2 testing capacity at the point of care and in laboratories.
The four contracts will be administered by NIH's Rapid Acceleration of Diagnostics Tech (RADx Tech) initiative to help support the companies in manufacturing and scaling up their tests. Each of the companies has achieved key RADx Tech milestones, NIH said in a statement.
Included in the new funding are contracts for tests to detect and identify new variants of SARS-CoV-2, the institute noted, adding some variants may compromise the effectiveness of COVID-19 therapeutics and vaccines.
"We need tests that are able to detect and identify variants. This is crucial to tracking the prevalence of variants and monitoring any impact on treatments and vaccines," Bruce Tromberg, director of the National Institute for Biomedical Imaging and Bioengineering and lead for RADx Tech, a program in RADx, said in a statement.
South Korea-based GenBody received a contract for its visually read, single lateral flow rapid test system that can return results in 20 minutes. The test uses nasopharyngeal or nasal swabs and is performed by a healthcare professional at the point of care. NIH said that the company has an at-home test in development as well.
Xtrava Health, based in Santa Clara, California, also received an award for its lateral flow immunoassay platform technology to detect SARS-CoV-2 antigens from shallow nasal samples. The test returns a visible line in positive samples within 15 minutes and can be used at the point of care or for health monitoring in shared public spaces, such as a sports arena. The company is developing a portable digital reader to improve sensitivity and an accompanying smartphone app for over-the-counter use.
PathogenDx nabbed the NIH contract for its low-cost, high-throughput test targeting multiple genetic sites in the SARS-CoV-2 virus to detect and identify variants. The test returns results in five hours and can also be used to pool up to six saliva samples for surveillance testing, NIH said. The test can currently be used with saliva, nasopharyngeal swabs, and oral samples and 96 samples can be run at a time.
Meridian Bioscience also received a contract for its single-use, automated, microfluidic cartridge-based RT-PCR test for use with nasopharyngeal swabs. The $5.5 million contract was previously announced by Meridian in February. The test provides results in 45 minutes and is intended for use in laboratories, and NIH said the company plans to pursue regulatory approval for use in both high- and moderate-complexity labs. Cincinnati-based Meridian is also working on a respiratory panel that will include SARS-CoV-2, influenza A/B, and respiratory syncytial virus.