T2 Biosystems Announces direcT2 Pivotal Clinical Trial of T2Candida Enrolling at All Clinical Sites

T2 Biosystems Announces direcT2 Pivotal Clinical Trial of T2Candida Enrolling at All Clinical Sites

September 9, 2013

--T2Candida Directly Detects Species-specific Candida from Whole Blood in Approximately Three Hours--

LEXINGTON, Mass., Sep 09, 2013 (BUSINESS WIRE) -- T2 Biosystems, a company developing direct detection products enabling superior diagnostics, today announced the initiation of the direcT2 clinical trial of T2Candida(R), T2 Bio's flagship product for the rapid and sensitive identification of five species of Candida. The direcT2 trial will provide data to support a regulatory submission for T2Candida. T2Candida uses the Company's proprietary T2MR(R) technology to detect the presence of Candida, a fungal pathogen known to cause sepsis, directly from whole blood in approximately three hours.

"With a mortality rate of over 40%, Candida infections pose a serious healthcare problem, and physicians are constrained in their treatment of these infections largely by the lengthy amount of time required to positively identify the pathogen and administer appropriate therapy," said Peter Pappas, MD, Principal Investigator, Mycoses Study Group, Professor, University of Alabama, Birmingham. "T2Candida offers a potentially dramatic shift in our ability to diagnose this infection, and we are therefore excited to participate in this study to see the impact that this rapid and sensitive assay may have."

"It has been shown that if appropriate treatment is given within 12 hours of Candida infection, the mortality rate is reduced to 11%. With species-specific Candida identification in approximately three hours, T2Candida would have a profound impact on both the high mortality rate of candidemia and the tremendous cost that these infections bring to patients, hospitals and payors," commented Michael Pfaller, MD, Professor Emeritus, University of Iowa.

Previously reported data have demonstrated that T2Candida identifies five different species of Candida with a limit of detection as low as 1 CFU/mL in approximately three hours. T2Candida's detection capability is therefore 25 times faster than blood culture, the current gold standard for Candida identification, a process that can take from two to five days.

"The direcT2 trial initiation is a significant milestone for T2 Bio in our mission to improve patients' lives utilizing T2MR, our disruptive diagnostic technology," stated John McDonough, President and CEO, T2 Biosystems. "T2Candida is the first of many applications to emerge from our T2MR technology, which can directly detect molecular, immunoassay or hemostasis targets from complex clinical samples, such as whole blood, and we look forward to the results of the trial, which we expect to report in the first half of 2014."

About Candidemia/Sepsis

Sepsis is a potentially life-threatening illness caused by the body's severe reaction to infection by bacteria, fungi, viruses or parasites. It is one of the top 10 leading causes of death in the United States, and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis, and it is associated with approximately 100,000 cases of candidemia in the U.S. annually, making it the fourth-leading cause of hospital-acquired infections. Currently, candidemia has a greater than 40% mortality rate, which can be reduced to 11% with appropriate treatment within 12 hours of presentation. Current detection methods rely on blood culture, a process that can take two to five days before identifying a Candida infection. The T2MR(R) platform is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology, even at low copy numbers, and provide results in approximately three hours.

About T2 Biosystems

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR(R), the Company's proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate and rapid assay results. The Company's products are capable of detecting molecular or immunoassay targets as well as hemostasis biomarkers directly from unpurified clinical samples in hospitals, labs and physicians' offices. For more information, please visit www.t2biosystems.com.

SOURCE: T2 Biosystems