The US Food and Drug Administration (FDA) has granted breakthrough device designation for T2 Biosystems’ T2Lyme Panel.
A direct-from-blood molecular diagnostic test, the T2Lyme Panel has been designed to detect the Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii bacteria, which cause Lyme disease, directly from a patient’s blood.
It runs on the FDA-cleared T2Dx Instrument and has been developed to support early diagnosis of the disease.
Early diagnosis allows appropriate treatments to be provided quickly, which helps to prevent or reduce the complications and significant costs associated with the disease.
According to preclinical data, the device provides superior accuracy compared to other diagnostics used for detecting Borrelia infections in patients that are suspected of having Lyme disease.
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T2Biosystems chairman and CEO John Sperzel said: “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 antibiotics.”
The company stated that the latest move follows the issuance of a patent number that covers the T2Lyme Panel by the US Patent and Trademark Office.
At present, there are no sensitive FDA-approved diagnostic tests to detect the disease in its early stages.
Nearly 476,000 people are annually diagnosed and treated for Lyme disease in the US, according to the US Centers for Disease Control and Prevention (CDC).
