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 programs.
The company will offer mobile app-based instructions to guide the user through the test-taking process and is developing an electronic travel pass system with an add-on telehealth service to ensure that results can be used for travel and event entry.
“The Detect Covid-19 Test brings laboratory accuracy into the home, helping to mitigate Covid-19 transmission and make everyday activities safe and anxiety-free again,” Detect Founder Dr. Jonathan Rothberg said in the release. “As a complement to vaccines, highly accurate rapid testing will be critical as the pandemic becomes endemic. We developed the Detect Covid-19 test to help people return to doing the things they love with the people they love in the safest way possible.”