A major step toward containing the explosive spread of COVID-19 infections is to identify and isolate those carrying the virus who may have no symptoms. Recent advances in testing technologies for COVID-19 are raising hopes that better and more accurate tests are coming soon.
On October 6, 2020, the National Institutes of Health announced its Rapid Acceleration of Diagnostics (RADx) initiative, a partnership that the Biomedical Advanced Research and Development Authority (BARDA) has awarded six new contracts. These awards, totaling over $98 million, support scale-up and manufacturing of new tests with advanced means of collecting and processing samples and reporting results.
This round of awards is part of the RADx Tech program, which focuses on quickly advancing early testing technologies. The RADx Advanced Technology Platforms (RADx-ATP) program supports later stage scale-up projects. Combined with the six new awards and previous awards from rounds in July and September, the RADx program expects to add 2.7 million tests per day to U.S. testing capacity per day by the end of 2020. Here’s a summary of the types of tests the six new awards will support.
Viral Antigen Testing
Using fluid samples from nasal passages, saliva, or blood, these tests detect proteins that are part of the coronavirus that causes COVID-19.
Three antigen tests will receive support for manufacturing. One uses two cartridges that hold a digital fluorescent immunoassay antigen test that can return results in fifteen minutes. The results can be read at the point of care or in the lab. A similar home test using a nasal swab is in the works.
A rapid test that provides a readout to a smartphone is also among the new technologies receiving support. This one uses glow-in-the-dark nanomaterials to detect the presence of COVID-19 from samples taken with nasal swabs. Both point of care and home versions are planned.
Finally, RADx awarded support for its supersensitive, single molecule immunoassay technology that can provide results from saliva, nasal swabs, or blood. This test will use existing sample collection, transport, and processing labs to obtain results.
Viral RNA Detection
Three other awards went to companies developing viral RNA detection technologies. A mobile lab in a van that can travel to underserved areas and hotspots uses a new technology to extract and purify RNA to detect the virus’ presence in asymptomatic people. This will be a major aid to efforts to contain the spread of COVID-19.
Another award went to support the scale-up of a small, single-use rapid polymerase chain reaction (PCR) point of care tests designed so health care workers with minimal skills can use it to provide results in 30 minutes. PCR testing is considered the “gold standard” of virus detection tests.
The sixth contract went toward a mobile, battery-operated, high-accuracy RT-PCR test that reports results in 40 minutes through a proprietary iPhone app.
RADx considered accuracy, speed, cost, and accessibility in making the awards. The program offers money and expertise to help test manufacturers achieve required milestones toward FDA approval, scale-up, and commercialization.
Detection of disease conditions and advances in testing technologies begin with diagnostic product development. Alongside advances to address the COVID-19 crisis, scientists and engineers in the medical diagnostic device development field are working to create tests to diagnose a wide variety of other disease conditions, from viral infections to chronic diseases such as diabetes.