Hologic
(Nasdaq: HOLX)
today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV.
“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” Hologic Diagnostic Solutions President Jennifer Schneiders said in a news release.
“While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season, and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine which respiratory virus or coinfection patients have so that providers can better inform the best course of treatment.”
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on Hologic’s fully automated, high-throughput Panther Fusion system. Panther Fusion can provide initial results in roughly three hours, with the ability to process more than 1,000 tests in 24 hours.
The flexible approach of this system, along with Hologic’s respiratory virus menu, offers various testing options from a single sample and allows healthcare professionals and laboratories to personalize patient testing based on medical history and local prevalence, according to Hologic.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect collection kit. RespDirect enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps. Hologic says this design improvement saves time and reduces the potential for error repetitive stress injuries and exposure to viruses.
The U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority funded much of the project behind the new assay. The contract number was 75A50121P00022.
Hologic has shipped more than 200 million SARS-CoV-2 laboratory diagnostic tests worldwide since the onset of the COVID-19 pandemic.