Hologic receives FDA clearance for combined flu, RSV, COVID test

PHOTO | Courtesy of Hologic The Panther Fusion system from Hologic

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By Isabel Tehan

Marlborough medical device manufacturer Hologic has received U.S. Food and Drug Administration clearance for a new combined test that can detect influenza A and B, respiratory syncytial virus (RSV) and coronavirus.

The new test, called the Panther Fusion assay, is a molecular diagnostic tool that can differentiate between these common respiratory illnesses, according to a Friday press release from Hologic.

“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,” Jennifer Schneiders, Hologic president of diagnostic solutions, said in the press 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.”

The company was awarded a $19-million contract from the U.S. Department of Health and Human Services in November to continue its development of COVID, flu, and RSV tests it began during the pandemic. That funding was used in the development of this new testing product, according to the press release.

The test can be used in a variety of laboratory settings and can deliver results in approximately three hours. The automated testing system can run 1,000 tests in a 24-hour period.

The accompanying testing equipment, called the RespDirect collection kit, is newly launched and will allow for specimen processing without uncapping, resulting in less error and virus exposure.

“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,” Schneiders said.