As labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets.

The tracker includes only those tests that are available for diagnostic and clinical use. Links to primary regulatory decisions are provided where available. We rely on information provided by manufacturers and regulatory authorities. If you're a test manufacturer or provider and believe your test should be on this tracker, please email us at [email protected].

Last updated: Sept. 18, 2020

EUA: Emergency Use Authorization

EUA submission pending: Test manufacturers have indicated that they have submitted an EUA application. FDA requires labs and commercial manufacturers to submit an EUA request within 10 days (serological test) or 15 days (molecular test) of completing test validation.

Under CDC's EUA: these manufacturers are covered under the EUA granted to the US Centers for Disease Control and Prevention

*See US FDA Revised Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency