FDA Clearance for T2 Biosystems Diagnostic Panel
    FDA Clearance for T2 Biosystems Diagnostic Panel
    PRISM Biotech

    February 12, 2024 - by Catie Corcoran

    FDA Clearance for T2 Biosystems Diagnostic Panel

    12 February 2024

    New York, February 12, 2024 - PRISM MarketView - T2 Biosystems, Inc. (Nasdaq: TTOO) has received 510(k) clearance from the FDA for its expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to its panel.

    T2 Biosystems, Inc. - Prism MarketView

    T2 Biosystems, Inc., an in vitro diagnostics company, develops diagnostic products and product candidates in the United States and internationally. It provides

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    T2 Biosystems Receives FDA 510(k) Clearance for the Expanded T2Bacteria Panel - Prism MarketView

    T2 Biosystems, Inc.Increases number of bacteria species detected with addition of Acinetobacter baumanniiLEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader...

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    The T2Bacteria Panel is the first and only FDA-cleared product able to detect sepsis-causing pathogens directly in whole blood, in just 3 to 5 hours. It detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii.

    "We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform. The addition of A. baumannii represents the achievement of another successful product development and regulatory milestone for T2 Biosystems and increases the value proposition of the T2Bacteria Panel by covering approximately 75% of all sepsis-causing bacterial pathogens commonly found in bloodstream infections.”

    John Sperzel, Chairman and CEO

    Highlights
    A. baumannii is a cause of bloodstream infections, especially in critically ill patients, and can result in septic shock.
    Infections pose a significant risk to patients on ventilators, those with catheters or open wounds from surgery.
    The World Health Organization has identified A. baumannii as the most critically important bacteria that requires improved prevention and therapeutic approaches.
    About T2 Biosystems
    T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the Candida auristest, and the T2Lyme™ Panel. For more information, please visit www.t2biosystems.com.

    Welcome To T2 Biosystems | T2 Biosystems

    T2 could save lives – bottomline. Get patients on the right therapy faster. Improve morbidity and mortality outcomes. Reduce costs.

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