US-based medical technology company Hologic has received the US Food and Drug Administration (FDA) 510(k) approval for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses.
The four respiratory viruses, SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), may show similar clinical symptoms.
It runs on the fully automated, high-throughput Panther Fusion system, which can process more than 1,000 tests in 24 hours and provide initial results in about three hours.
The Panther system is an advanced, fully automated, sample-to-result molecular diagnostics platform that can be used in low-, medium- or high-throughput laboratories.
Hologic diagnostic solutions president Jennifer Schneiders said: “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.
“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.”
Hologic said that the flexible approach of the Panther system, along with the company’s respiratory virus menu, offers various testing options from a single sample.
The company allows healthcare professionals and laboratories to personalise patient testing based on medical history and local prevalence.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay has been launched with the new RespDirect collection kit, which also runs on the Panther Fusion system.
The RespDirect collection kit enables laboratories to directly load samples without any uncapping or specimen transfer steps, saving time and reducing the potential for error.
Hologic said that the project has been partly funded by federal funds from the US Department of Health and Human Services.
The FDA approval follows CE mark approval of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in Europe, in July last year, said the medical device company.
