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With FDA Nod, T2 Bio’s Sepsis Test Heads to Commercial Proving Ground

Xconomy Boston — 

T2 Biosystems believes that its quick method for testing patients for dangerous viral and bacterial infections could save the healthcare system a lot of money, and save some lives as well. With a key regulatory decision now in the bag, the Lexington, MA-based company will get its chance to prove it.

The FDA late Monday approved T2’s (NASDAQ: TTOO) first products, the T2Dx, a diagnostic instrument, and the T2Candida, a test that runs on the T2Dx. Those approvals mean that eight-year-old T2 can now make the transition from a clinical-stage company to one that can begin generating revenue. That’s an important milestone for the company, but it comes with a big challenge: T2 is going to have to successfully convince many of the top hospitals in the country to buy in, and depend on its test to make critical, quick decisions of whether or not to administer a potentially life-saving antifungal drug—before getting the results from traditional blood culture-based diagnostics.

“These things take time to adopt,” says T2 CEO John McDonough. “Different people need different amounts of data and reasons to move.”

For those unfamiliar with T2, the company was started up by a big cast of business people and researchers from MIT (Tyler Jacks, Bob Langer, Michael Cima) and Massachusetts General Hospital (Ralph Weissleder and Lee Josephson). They came up with a bench-top machine that uses miniaturized magnetic resonance detection and magnetic nanoparticle probes to identify biological substances like proteins, small molecules, viruses, and DNA.

The selling point here is that T2’s technology can do this faster—in a few hours, rather than a few days—than traditional optical-based machines and blood culture-based diagnostic tests, which involve sending blood samples to a lab, incubating them, and seeing if harmful organisms (like bacteria) grow along with other cells. T2 eliminates that culture step. Clinicians just have to get a blood sample, load it into a cartridge with reagents, put that cartridge into T2’s machine, and wait for the analysis. T2 contends that the quicker turnaround time can save lives, lead to shorter hospital stays and cost savings, and in some cases prevent hospitals from administering antibiotics when they aren’t needed—an increasingly important issue given overusing antibiotics can help bacteria develop resistance.

T2’s first stab at this approach is the T2Dx and T2Candida, which are used to identify five species of a pathogen—Candida—known to cause 10 to 20 percent of sepsis cases in the U.S. (A follow-on product its developing called T2Bacteria would focus on the more common sepsis-causing bacteria.) Sepsis is a potentially deadly inflammatory response to an infection that is most common in patients with weak immune systems, such as cancer patients on chemotherapy, or transplant recipients taking immunosuppressants. Every year, it affects about 1 million people in the U.S. and 18 million worldwide.

Early detection of a sepsis-causing infection like Candida can make a big difference. On its site, T2 cites a published report from Antimicrobial Agents and Chemotherapy showing that the average mortality rate of a patient infected with Candida plummets from 40 percent to 11 percent when the right treatment is administered within 12 hours of symptoms. Further, the average Candida-infected patient stays in the hospital for 40 days and costs the system more than $130,000 apiece, according to McDonough.

Often, a hospital will administer antifungal drugs while waiting out the days it takes to get the results back from a blood culture-based diagnostic. So T2’s pitch is that it can get an accurate answer in an average of around four to five hours, so doctors can quickly diagnose and treat a patient—or not, if the patient comes up negative. T2Candida was approved by the FDA based on clinical trial of more than 1,500 patients in which it was tested compared to blood culture diagnostics. It was shown to … Next Page »

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