T2 Biosystems wins FDA approval for sepsis diagnostic system

John McDonough, CEO of T2 Biosystems

T2 Biosystems ($TTOO) won FDA approval to market its diagnostic system for sepsis, riding on the tailwinds of last month's IPO and moving the company forward on its path toward full commercialization of the product.

The Lexington, MA-based company scored market authorization for its T2Dx device and T2Candida test that runs on the diagnostic instrument, a system that detects Candida in human blood specimens of patients with fungal infections. Unlike other diagnostic systems, the products can identify sepsis-causing pathogens from a whole blood specimen in four hours. All other FDA-cleared tests require cultured blood samples and take two to 5 days to process results, T2 Biosystems said in a statement.

"The FDA's market authorization of T2Candida and T2Dx marks a significant milestone for our company, but more importantly for the more than 800,000 U.S. physicians across the country in need of faster diagnostic results so they can make timely and informed treatment decisions for their patients," CEO John McDonough said in a statement. "We believe the diagnostic capabilities offered by these products can support both improved clinical outcomes, as well as strong health economic benefits, and we look forward to working closely with the medical community to bring this novel diagnostic test to hospitals, physicians and patients."

Federal regulators based their approval on a clinical trial of more than 1,500 patients in which T2's diagnostic system was compared with traditional blood culture diagnostics. The company's test showed a 91.1% sensitivity, as opposed to blood culture tests, which yielded a 60% to 70% sensitivity, McDonough told Xconomy.

T2, a 2012 Fierce 15 winner, touts its test as a money- and lifesaver. A typical patient with a Candida infection averages 40 days in the hospital, resulting in an average cost per stay of more than $130,000, the company said in a statement. T2's test provides more timely data, potentially reducing costs and avoiding unnecessary antifungal treatment.

The company is well on its way to rolling out its T2Dx system. In early August, T2 raised just over $57 million in an IPO, well below its initial projections. But despite an initial lag, the company's stock price peaked this summer at $23.21 on Aug. 29. McDonough told Xconomy that the company hopes to round out a 15-person sales force by the end of 2015 and is targeting top hospitals around the country with the goal of securing 30 as customers by next year.

T2's stock closed at $16.93 upon news of the FDA milestone, up 4.7% from the previous day's trading. In after-hours trading, the price shot up 2% to $17.28.

- read T2 Biosystems' statement
- get more from Xconomy
- here's FierceDiagnostics' take

Special Report: FierceMedicalDevices' 2012 Fierce 15 - T2 Biosystems - 2012 Fierce 15

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