08:31 AM EST, 02/18/2025 (MT Newswires) -- Hologic ( HOLX ) said Tuesday that the US Food and Drug Administration has granted 510(k) clearance for its Aptima SARS-CoV-2 assay.

The company said the test can detect and quantify genetic sequences to determine if respiratory viral pathogens are present.

A 510(k) clearance allows a medical device to be marketed if it can demonstrate substantial equivalence to an existing approved device.