T2 Biosystems Says FDA Grants Breakthrough Device Designation For T2Lyme Panel

(RTTNews) - T2 Biosystems, Inc. (TTOO) announced Monday the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Company's T2Lyme Panel.

The T2Lyme Panel is a direct-from-blood molecular diagnostic test designed to run on the FDA-cleared T2Dx Instrument and simultaneously detect the bacteria that cause Lyme disease.

The T2Lyme Panel is intended to test individuals with signs and symptoms of Lyme disease and aid in the diagnosis of early Lyme disease.

Currently, there are no sensitive FDA-cleared diagnostic tests for the detection of early Lyme disease. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year.

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