Medical technology company Hologic has secured the US Food and Drug Administration (FDA) 510(k) approval for Aptima SARS-CoV-2 assay.
The assay initially received Emergency Use Authorization (EUA) 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.
It is designed for individuals showing symptoms of respiratory tract infections.
Hologic said the nasal swab offers a less invasive and simpler alternative to the NP swab, which requires a healthcare professional to perform. The method reduces patient discomfort, pain, and anxiety by only inserting the swab into the nostril entrance.
The Aptima SARS-CoV-2 Assay uses Hologic’s transcription-mediated amplification (TMA) chemistry to detect and quantify genetic sequences of respiratory viral pathogens.
Samples are processed on Hologic’s Panther system, widely used in labs across the US and globally. The Panther system is an automated, sample-to-result molecular diagnostics platform.
Each Panther can deliver initial results in under three hours and process over 1,000 tests per day. Customers can also enhance their testing capabilities by adding the Panther Fusion module, enabling access to a broader range of respiratory assays.
Hologic Diagnostic Solutions president Jennifer Schneiders said: “With the virus now in an endemic state, full FDA clearance will give laboratories and clinicians peace of mind that they can continue to rely on the test to make informed decisions about patient treatment and the management of healthcare resources.”
FDA clearance for the assay supports Hologic’s commitment to emergency preparedness and respiratory diagnostics.
In addition to the Aptima SARS-CoV-2 assay, Hologic recently received FDA clearance for several other respiratory tests.
In May 2023, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was cleared for use with nasopharyngeal samples.
In July 2024, the same assay received FDA clearance for use with anterior nasal swabs.
Then, in November last year, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was expanded for use with anterior nasal swabs transported via enhanced specimen transport media (eSTM).
The development of the Aptima SARS-CoV-2 assay was funded in whole or in part with federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.
In December 2024, Hologic collaborated with the US Centers for Disease Control and Prevention (CDC) to develop analyte-specific reagents (ASRs) for H5N1 detection.
