The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, which was originally authorized under Emergency Use Authorization in May 2020. This molecular diagnostic test, designed to detect SARS-CoV-2 RNA, remains widely used in clinical practice nearly 5 years after the pandemic's onset and can process over 1,000 tests per day. Jennifer Schneiders, PhD, President of Hologic Diagnostic Solutions, stated that full FDA clearance provides laboratories and clinicians confidence in the test’s continued utility as SARS-CoV-2 transitions to an endemic state.

The Aptima SARS-CoV-2 assay is validated for use with nasopharyngeal and nasal swab specimens collected from symptomatic patients. Compared with nasopharyngeal collection, nasal swabs offer a less invasive testing alternative, reducing patient discomfort, pain, and anxiety while maintaining diagnostic accuracy. The assay employs Hologic’s transcription-mediated amplification chemistry, a highly sensitive method for detecting and amplifying viral RNA. Samples are processed on the Panther system, a fully automated, high-throughput molecular diagnostics platform that delivers initial results in under 3 hours and can process more than 1,000 tests in a 24-hour period, optimizing laboratory efficiency. Laboratories may integrate the Panther Fusion module to expand respiratory pathogen detection capabilities. The Panther Fusion module further enhances diagnostic capabilities with expanded test menus and Open Access functionality for laboratory-developed tests.

Hologic has secured additional FDA clearances for respiratory diagnostic assays. The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received approval for nasopharyngeal specimens in May 2023, followed by authorization for anterior nasal swabs in July 2024. In November 2024, its clearance was extended to include anterior nasal swabs transported via enhanced specimen transport media.

Development of the Aptima SARS-CoV-2 assay was funded through the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority. 

Reference: 

Hologic, Inc. Hologic announces FDA clearance of Aptima SARS-CoV-2 assay. https://investors.hologic.com/press-releases/press-release-details/2025/Hologic-Announces-FDA-Clearance-of-Aptima-SARS-CoV-2-Assay/default.aspx