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     141  0 Kommentare Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay - Seite 2

    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.

    About Hologic

    Hologic Inc. is a global medical technology innovator focused on improving the health and well-being of women, their families and communities through early detection and treatment. For more information on Hologic, visit www.hologic.com.

    Forward-Looking Statements

    This press release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic’s diagnostic products. There can be no assurance that these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

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