Hologic has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its fully automated and high-throughput Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
The molecular diagnostic test is intended for the detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV). These four respiratory viruses have similar clinical symptoms.
Hologic diagnostic solutions president Dr Jennifer Schneiders said: “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.”
With a capacity to process more than 1,000 tests in 24 hours, the system can offer initial results in about three hours.
The company is launching the new assay with the RespDirect collection kit, which allows laboratories to load samples directly onto the Panther Fusion system.
It helps eliminate uncapping and specimen transfer steps, save time and reduce errors, injuries and viral exposure risks.
The US Department of Health and Human Services, along with the Biomedical Advanced Research and Development Authority and the Administration for Strategic Preparedness and Response, provided financial support for this project.