TTOO - T2 Biosystems granted FDA Breakthrough Device Designation for Lyme disease test
- The U.S. FDA has granted FDA Breakthrough Device Designation for T2 Biosystems' T2Lyme Panel , which is used to detect early Lyme disease.
- Shares are up 11% in premarket trading.
- The panel, a direct-from-blood molecular diagnostic test, is designed to work on the company's T2Dx Instrument to detect bacteria that cause the disease.
- T2 ( NASDAQ: TTOO ) said that current diagnostic tests for Lyme rely on detecting the presence of antibodies to the bacteria. However, those antibodies can take a few weeks to develop, so patients can test negative even if they are infected.
- Seeking Alpha's Quant Rating views T2 ( TTOO ) as a strong sell with poor grades on profitability and momentum.
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T2 Biosystems granted FDA Breakthrough Device Designation for Lyme disease test