The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for T2 Biosystems’ TTOO T2Lyme Panel, intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease.
The regulatory grant follows the decision by the U.S. Patent and Trademark Office to grant T2 Biosystems a patent covering the T2Lyme Panel.
John Sperzel, Chairman and CEO, commented : "We are pleased with the FDA's decision to grant Breakthrough Device Designation for the T2Lyme Panel, as it brings us one step closer to providing clinicians with a valuable tool to detect Lyme disease earlier. Similar to the value proposition of our sepsis panels, we believe the T2Lyme Panel will allow clinicians to ensure patients receive the appropriate therapy faster, and prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotic.”
The FDA Breakthrough Devices designation is applicable for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request).
Price action : T2 Biosystems shares are trading around 9 percent higher at $0.16 on Monday at the time of publication.
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