The US Food and Drug Administration (FDA) has granted 510(k) clearance to Hologic’s Aptima SARS-CoV-2 assay, marking an advancement since its initial emergency use authorisation (EUA) was granted in May 2020.
The in vitro diagnostic test leverages the company’s transcription-mediated amplification (TMA) chemistry that can identify and quantify genetic sequences to determine the presence of respiratory viral pathogens.
It identifies SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples collected from individuals showing symptoms of respiratory tract infection.
The company stated that a nasal swab is said to be less discomforting than the deeper nasopharyngeal swab.
The US Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority, and the Administration for Strategic Preparedness and Response, have substantially provided the funding for developing this assay under contract number 75A50122C00074.
Hologic’s Panther system, on which the assay runs, processes the samples, delivering initial outcomes in under three hours and handling more than 1,000 tests within 24 hours.
Laboratories can enhance their respiratory testing capabilities by integrating a Panther Fusion module, which supports a broader range of respiratory assays.
Hologic diagnostic solutions president Jennifer Schneiders said: “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.”
The FDA has also cleared several other respiratory tests of the company for SARS-CoV-2 detection.
These include the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay for use with nasopharyngeal samples in May 2023.
In November 2024, it was expanded for use with anterior nasal swabs transported through enhanced specimen transport media.
The company agreed with the US Centers for Disease Control and Prevention in December 2024, to develop analyte-specific reagents for detecting the H5N1 bird flu.
