T2 Biosystems – 2012 Fierce 15

John McDonough, CEO of T2 Biosystems

Based: Lexington, MA
Founded: 2006
Website: www.t2biosystems.com/Site/

The Scoop: T2 Biosystems bills itself as fielding "truly disruptive diagnostics technology that can handle rapid direct detection of any molecular or immunologic target for any clinical sample, including blood and sputum, eliminating the time-consuming sample prep required in current methods." T2's tech is based on work by diagnostic pioneers at MIT, Harvard and Massachusetts General Hospital by Robert Langer, Michael Cima, Lee Josephson and others and the company is funded by "blue-chip VCs."

What Makes It Fierce: T2 Biosystems is gearing up for human clinical trials with its first-ever product: the T2Candida rapid diagnostic assay, which is designed to identify the deadly blood-borne fungal infection within two hours. Human clinical trials should get under way within 6 months, and plans call for enrolling 1,500 patients suspected of having Candida over three to 6 months. If all goes well, T2 will submit a 510(k) to the FDA, likely with a de novo designation, by next summer. Executives are betting that they can gain clearance within 6 months of submission. The method of detection is what is novel. Plenty of diagnostics systems use magnets to pull an analyte out of a sample. But T2's magnetic resonance (T2MR) platform, which is the basis behind T2Candida and other tests further down the pipeline, uses magnets the size of a quarter to perform the detection itself, explains CEO John McDonough, a former president of Cytyc Development.

Such an advance would be a game-change approach to diagnosing and treating Candida infections. They carry a 40% mortality rate, in part, because clinicians typically must culture a blood sample over two to 5 days before they can determine a positive diagnosis. By then, the infection is often too far gone; it kills 90,000 people in the U.S. each year.

"It takes a long time to detect the presence of this disease," says McDonough.

T2MR detects an infection within a blood or urine sample without having to clean the sample up first for more time-consuming culturing. Like in every other platform, a DNA probe is used to bind to a targeted strand of DNA within a given sample. A cluster forms inside that sample and then the magnetic properties of the surrounding water molecules change. That's what T2 can detect with its novel system. One cell per milliliter is enough to formulate a diagnosis. McDonough says T2Candida works so quickly based on earlier tests that it could lead to rapid patient treatment within 12 hours and help drop the mortality rate to 10%.

The technology and the high-caliber talent behind it have drawn $53 million in venture funding since T2 launched in 2006. T2's investment slate also represents a veritable "who's who" of venture investors and life sciences talent: Aisling Capital, Flagship Ventures, Polaris Venture Partners, Flybridge Capital Partners, Physic Ventures, Partners Healthcare, Arcus Ventures, RA Capital, Camros Capital and WS Investments.

What To Look For: McDonough says the company has developed "a tremendous amount of interest" in its platform technology, and that the company has "a large number of discussions going on with potential development partners for new applications of our technology or expanded uses of our technology with the sepsis market itself." Potential partners include larger diagnostic companies, and also therapeutic companies who are interested in developing companion diagnostics tied to individual treatments. Also, T2 will likely launch another venture financing round in the first half of next year.

-- Mark Hollmer (Twitter | email) 

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T2 Biosystems – 2012 Fierce 15