Detect wins FDA authorization to sell COVID-19 test over the counter

[Image from Detect]Detect announced today that it received FDA emergency use authorization (EUA) to sell its COVID-19 test over the counter.

Guilford, Connecticut-based Detect develops a molecular rapid test designed to identify SARS-CoV-2, the virus causing COVID-19, at lower viral loads than antigen tests to allow for earlier detection, according to a news release.

The Detect COVID-19 test, which can be done entirely at home in one hour, demonstrated 97.3% overall agreement with 90.9% sensitivity and 100% specificity when test results were interpreted correctly in comparison with a highly sensitive PCR test in clinical studies. The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Initiative¬†(RADxSM) recently selected Detect’s test for an $8.1 million contract to scale up manufacturing.

Retail pricing for the Detect test will come in under $50, the company said. It will be used in schools and workplaces for regular screening prog…

Read more
  • 0