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Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Multiplexed Respiratory Test Now Available in the U.S. With New RespDirect Collection Kit

Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’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,” said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. “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. 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, saving time and reducing the potential for error, repetitive stress injuries and exposure to viruses.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121P00022.

Since the beginning of the COVID pandemic, Hologic has shipped more than 200 million SARS-CoV-2 laboratory diagnostic tests worldwide. FDA clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay follows the July 2022 announcement of CE marking for the same test in Europe, furthering Hologic’s position as one of the world’s largest molecular diagnostic companies.

About the Panther and Panther Fusion Systems

The Panther system is a best-in-class, fully automated, sample-to-result molecular diagnostics platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection, respiratory infection, viral load, transplant viruses and other infectious disease testing, which can all be done simultaneously. The Panther Fusion module, which is an addition to the Panther system, provides an expanded and growing in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests. Learn more about Panther Fusion Respiratory Assays.

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