T2 BIOSYSTEMS RECEIVES CE MARK FOR T2BACTERIA™ PANEL ENABLING COMMERCIALIZATION IN EUROPE
T2 Biosystems, Inc. (TTOO)
Last t2 biosystems, inc. earnings: 2/24 04:05 pm
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Source: GlobeNewswire
LEXINGTON, Mass., July 18, 2017 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the Company’s proprietary T2Dx® Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product
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TTOO
Sec Filings
- 4/19/24 - Form SC
- 4/18/24 - Form 8-K
- 4/16/24 - Form 4
- TTOO's page on the SEC website