NEW YORK – Hologic said on Tuesday that it has received US Food and Drug Administration 510(k) marketing clearance for a SARS-CoV-2 test that had been available since 2020 through an Emergency Use Authorization.
The Aptima SARS-CoV-2 Assay is a transcription amplification (TMA) chemistry-based test that is used for the quantitative detection of SARS-CoV-2 RNA in nasopharyngeal or nasal swab samples from patients with signs and symptoms of respiratory tract infection. The test is designed for use on Hologic's fully automated sample-to-result Panther instrument, which can provide initial results in about three hours and has a throughput of more than 1,000 tests in 24 hours.
Hologic Diagnostic Solutions President Jennifer Schneiders said in a statement that the test helped to address critical testing needs during the SARS-CoV-2 pandemic, and the test remains widely used nearly five years later.
"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 management and the management of healthcare resources," she said.
The Marlborough, Massachusetts-based firm noted that it also received in 2023 and 2024 FDA clearances for its Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, which is designed for use on the PCR-based Panther Fusion module that is used with the base model Panther instrument. That test is cleared for use with nasopharyngeal and anterior nasal swab samples.
Hologic officials said a year ago that the company had been improving its lineup of TMA-based Aptima assays while all newer tests were being developed for the Fusion.