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T2 Biosystems begins enrollment for direcT2 pivotal clinical trial

T2 Biosystems has initiated the direcT2 clinical trial of T2Candida, designed for the rapid and sensitive identification of five species of Candida.

The direcT2 trial will provide data to support a regulatory submission for T2Candida.

The test using company’s proprietary T2MR technology identifies and detects sepsis-causing Candida species from whole blood at ~1CFU/mL sensitivity in three hours.

The earlier clinical studies have reported that T2Candida identifies five different species of Candida with a limit of detection as low as 1 CFU/mL in approximately three hours.

The infection has a mortality rate that surpasses 40%, and the T2Candidate can help reduce that substantially with a much faster diagnosis compared to standard methods.

T2 Biosystems president and CEO John McDonough said the direcT2 trial initiation is a significant milestone for T2 Bio in our mission to improve patients’ lives utilizing T2MR, company’s disruptive diagnostic technology.

"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," McDonough added.