Hologic has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
 
The assay is a molecular test that spots and differentiates four of the most common respiratory viruses that can show 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,” Hologic Diagnostic Solutions president Jennifer Schneiders, Ph.D. told the press. “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 assay runs on Hologic’s fully automated, high-throughput Panther Fusion system, which generates initial results in about three hours and can process over 1,000 tests in a day. The flexible approach of this system offers various testing options from one sample.
 
The new assay also launches with the RespDirect collection kit, which lets labs directly load samples for processing on the Pather Fusion system without uncapping or specimen transfer steps. This saves time and reduces potential for error, repetitive stress injuries, and exposure to viruses.