JPM: T2 readies pivotal trial for Candida assay

John McDonough, CEO of T2 Biosystems

SAN FRANCISCO--T2 Biosystems will launch a pivotal trial for the company's rapid diagnostic assay for Candida infections by early February. What's more, the company expects to seek a $20 million Series E round over the coming year, CEO John McDonough told FierceMedicalDevices Monday during the J.P. Morgan Healthcare Conference in San Francisco.

Both milestones represent a big advance for T2, a 2012 Fierce 15 company with technology from MIT's Robert Langer, Harvard University and Massachusetts General Hospital.

"It feels great," McDonough said during an interview at the Villa Florence off Union Square, about a block from the ongoing conference at the Weston St. Francis Hotel. "The people in the company are very, very excited."

To date, Lexington, MA-based T2 has raised $53 million in four rounds since its 2006 launch. The trial, as we have previously reported, would enroll 1,500 patients at 5 different hospitals over a 6-month period suspected of having Candida, a deadly blood-borne fungal infection. Clinicians should be able to detect levels of Candida within about a few hours, versus blood tests that take three to 5 days with current methods. T2's magnetic resonance technology helps speed things up, in part because it can detect an infection in a blood or urine sample without having to clean up the sample for culturing, which can be time consuming.

If all goes well with the pivotal trial, T2 expects to seek 510(k) clearance, McDonough said, with a hoped for regulatory sign-off by the first half of 2013. So far, he added, the regulatory process has gone well, with the FDA being "very supportive telling us exactly what we need" and  "working closely" with the company. He also noted that regulators respond by email to T2's questions often within 24 hours.

Special Report: T2 Biosystems – 2012 Fierce 15