FDA OKs Hologic’s Aptima SARS-CoV-2 Assay

Hologic has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aptima SARS-CoV-2 assay, which was first awarded emergency use authorization (EUA) in May 2020.

The assay is an in-vitro diagnostic test to detect SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples gathered from people showing signs and symptoms of a respiratory tract infection.

The nasal swab is a simpler, less invasive alternative to an NP swab collection, which must be done by a healthcare practitioner. The nasal swab is minimally inserted into the nostril entrance to reduce discomfort, pain, and anxiety during testing.

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

Samples are processed on the company’s Panther system, which is used in labs across the U.S. and the world. Each Panther can provide initial results in under three hours and process over 1,000 tests in a 24-hour period.

“Our COVID test was instrumental in addressing critical testing needs during the pandemic and offered healthcare providers and laboratories a solution that was highly sensitive and able to help mitigate outbreaks. Nearly five years after the beginning of the pandemic, the test is still widely used,” said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. “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.”

In addition to the Aptima SARS-CoV-2 assay, the company earned FDA clearance for other respiratory tests to detect SARS-CoV-2:

• In May 2023, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with nasopharyngeal samples.
• In July 2024, The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with anterior nasal swabs.
• In November 2024, 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).