T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced that it has been named to the FierceMedicalDevices “Fierce 15” list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevices Editors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this year's winners based on their promising technologies and market opportunities, top management teams and notable financial backing. T2 Biosystems was chosen as one of the Fierce 15 based, in part, on its creativity and innovations in the industry.
“We will watch this company closely as it gears up for human clinical trials in 2013 for its T2Candida rapid diagnostic assay and a de novo regulatory submission later in that year. The test is a game-changer,” said Hollmer.
“We are honored to be selected as a member of the ‘Fierce 15’, an award that highlights T2 Biosystems’ potential to make a fundamental change in the diagnosis of diseases with our proprietary T2MR detector,” said John McDonough, CEO, T2 Biosystems. “Our dedicated scientists and engineers have created a technology that enables rapid, direct detection from any clinical sample, including blood, sputum and urine. Our initial assay panel, T2Candida, will aid in the reduction of the estimated 40% mortality rate associated with Candida infection through its ability to identify species-specific Candida directly from whole blood in about two hours, compared with current detection methods that take from two to five days.”
T2 Biosystems is developing the first-ever diagnostic system capable of direct detection in any clinical sample for accurate detection of molecular and immunological targets. T2 Biosystems has presented preclinical data on its assays currently in development: T2Candida will aid in the reduction of the mortality rate associated with Candida infection through rapid, sensitive, and specific Candida species detection; T2Hemostasis, which is capable of rapidly characterizing key coagulation, platelet and other hematologic factors directly from whole blood on a single, compact instrument; and T2Endotoxin, a novel method to screen injectable drugs and medical devices for the presence of endotoxins that are produced by gram negative bacteria or fungi.