Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today 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.

“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.”

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.

FDA clearance for Aptima SARS-CoV-2 underscores Hologic’s commitment to emergency preparedness and respiratory diagnostic solutions. In addition to the Aptima SARS-CoV-2 assay, Hologic recently received FDA clearance for several other respiratory tests that 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).

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 under contract number 75A50122C00074.

About the Panther and Panther Fusion Systems

The Panther system is a best-in-class, fully automated, sample-to-result molecular diagnostics platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines testing for women’s health, sexually transmitted infections, respiratory infections, viral load, transplant viruses and other infectious diseases, which can all be done simultaneously. The Panther Fusion module, which is an addition to the Panther system, provides an expanded and growing in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests.

About Hologic, Inc.

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. For more information on Hologic, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.

Hologic, The Science of Sure, Aptima, Open Access, Panther and Panther Fusion are all registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

SOURCE: Hologic, Inc.