T2 Biosystems Inc. says its new blood test for the cause of a deadly blood pathogen could help make huge reductions in the mortality rate in people infected with the fungus Candida.
The Lexington, Mass.-based company’s new molecular diagnostic panel can detect five species of the fungal infection Candida within two hours. Current tests can take at least two days and likely three to five, CEO John McDonough told MassDevice. Recent study results, slated to be presented at the annual meeting of the Mycoses Study Group in Philadelphia today, is to include an evaluation of more than 400 blood samples spiked with Candida albicans, Candida krusei, Candida glabrata, Candida tropicalis and Candida parapsilosis. The T2 Biosystems method picked up all five species with 95 percent sensitivity and 98 percent specificity.
"There is no optical diagnostic for this organism, which is really what’s exciting about this test," McDonough told us.
The T2 device uses a miniaturized version of a magnetic resonance imaging machine to deliver test results from a single blood sample. Citing the 40 percent mortality rate for the 60,000 patients who contract candidemia each year, McDonough said interventions that occur within 12 hours of detecting the infection could cut that death rate to 11 percent. In a press release, T2 cited estimates that patients who suffer from candidemia cost the U.S. healthcare system nearly $8 billion annually.
T2 is gearing up to file a de novo 510(k) clearance application with the FDA next year, McDonough said, adding that the company is also developing a bacterial diagnostic test panel and a therapeutic drug panel for cancer and transplant patients, who need to undergo frequent testing for drug levels. Both of those tests are about a year behind the fungal panel in T2’s development pipeline, he said.
Last year, T2 raised $15 million in a Series C round to support the benchtop device. The company raised $10.8 million in a Series B financing in 2008 (PDF).