The US Food and Drug Administration (FDA) has granted 510(k) clearance for Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. 

This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B), and respiratory syncytial virus (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,” says Hologic Diagnostic Solutions president Jennifer Schneiders, PhD, in a 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 the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours. According to the company, 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.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps.

FDA clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay follows the July 2022 announcement of CE marking for the test in Europe.

Photo caption: Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

Photo credit: Business Wire