The US Food and Drug Administration (FDA) has granted 510(k) clearance to Hologic's Aptima SARS-CoV-2 assay, marking an advancement since its initial emergency use authorisation (EUA) was granted ...

The Aptima SARS-CoV-2 Assay is an in vitro diagnostic test that detects SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples obtained from people exhibiting signs and symptoms of a ...

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Aptima® SARS-CoV-2 assay, which was first granted ...

Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency Use Authorization status in May 2020. Published ...

MARLBOROUGH, Mass., February 18, 2025--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s ...