On Feb. 18, 2025, Hologic announced 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 Emergency Use Authorization (EUA) status in May 2020.

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 respiratory tract infection. The nasal swab allows for a simpler, less invasive alternative to NP swab collection, which must be performed by a healthcare practitioner. The nasal swab is minimally inserted into the nostril entrance, which reduces patient discomfort, pain and anxiety during testing compared to the original NP swab method, which is inserted deep into the nasal cavity.

The test uses Hologic’s transcription-mediated amplification (TMA) chemistry, which can detect and quantify genetic sequences to determine the presence of respiratory viral pathogens.

Samples are processed on Hologic’s Panther® system, which is used in labs across the U.S. and around the world. Each Panther can provide initial results in less than three hours and process more than 1,000 tests in a 24-hour period. Customers may add a Panther Fusion® module to expand their respiratory testing offerings with the Panther Fusion respiratory assays.

Development of the Aptima SARS-CoV-2 assay was funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority.