T2 Biosystems’s T2Lyme Panel Gets FDA Breakthrough Device Designation

T2 Biosystems has gained a Breakthrough Device designation for its T2Lyme test panel for individuals with signs and symptoms of early Lyme disease.

The test detects several kinds of bacteria that cause Lyme disease, including Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii. Currently, there are no FDA-cleared sensitive diagnostic tests for the detection of early Lyme disease, the company said.

The device is designed to run on T2 Biosystems’ T2Dx equipment, which can run tests directly from whole blood.

The T2Lyme panel will help “prevent the negative impact of a delay in delivery of appropriate therapy and the overuse of antibiotics,” said John Sperzel, CEO of T2Biosystems.

The FDA grants Breakthrough Device status to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.