T2 Biosystems Inc. (NASDAQ:TTOO)
Shares of T2 Biosystems Inc. (NASDAQ:TTOO) rallied by 12.41% as investors reacted to news the company had received a CE mark for its T2Bacteria Panel. The CE mark paves way for the company to market and sell the product in all the countries within the European Union. The product will now be available as part of the T2Sepsis solution as of the third quarter.
Monday’s rally pushed the stock above this month’s lows of $2.50 a share. It awaits to be seen if the momentum will be strong enough to reverse a strong downtrend that threatens to plunge the stock to all-time lows.
T2 Biosystems Inc. (NASDAQ:TTOO) is a leading developer of innovative diagnostic products designed to improve patient health. The company is an emerging leader in the field of vitro diagnostics thanks to its FDA approved T2DX instrument and T2Candida Panel.
The company’s proprietary T2 Magnetic Resonance Technology is designed to lower mortality rates as well as improve patient outcomes. The technology also helps in the reduction of healthcare costs by assisting physicians in making targeted treatment decisions.
T2 Bacteria Panel
T2 Biosystems Inc. (NASDAQ:TTOO), T2 Bacteria Panel runs on the proprietary T2Dx instrument to provide high accurate species-specific test results of targeted bacterial infections. The product is currently available in the U.S. and the company is working on completing a pivotal trial after which it plans to file a 510(K) application with the FDA. Patient enrollment for the upcoming pivotal trial is 92% complete.
“The CE Mark of our T2Bacteria Panel is a significant milestone in our mission to save lives and improve healthcare by empowering clinicians to more effectively treat patients with sepsis faster than ever before,” said CEO, John McDonough.
The CE mark in Europe validates T2 Bacteria Panel technology as a Vitro Diagnostic Medical Device. The vitro diagnostic product has already proved to be reliable in the identification of six of the most deadly and prevalent bacteria species not covered by empiric therapy.
The T2 Bacteria Panel continues to register a significant increase in interest from new and existing customers under the Research USE Only program. Customers are currently testing the product as part of a testing phase expected to accelerate adoption post-FDA clearance.
“We are pleased to be close to finalizing the submission of our T2Bacteria Panel to the FDA,” said Tom Lowery Chief Scientific Officer.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.