T2 Biosystems’s nanoparticle labels can also be tailored to detect a wide variety of pathogens, as well as cancer cells and other biomarkers, including hormones. The company chose to target the infectious fungus Candida for its first product because it sees rapid detection as an unmet need that could motivate hospitals to invest in the instrument. The company has not yet disclosed the price of the device, which it plans to launch in 2012.
In the United States, about 60,000 patients a year contract candidemia—meaning Candida is present in the blood—and about 40 percent of these patients die from it. Studies have shown that intervening in 12 hours instead of a few days reduces candidemia mortality rates to 11 percent, says T2 Biosystems CEO John McDonough. He hopes that intervening in the two hours it takes to perform a test with his company’s device might have an even greater benefit. In tests on blood spiked with Candida, the T2 detection system detected the fungus 95 percent of the time and with a 98 percent specificity.
“Candida is a bad player if you have it in your blood,” says Philip Norris, associate director of the Blood Systems Research Institute at the University of California, San Francisco Medical Center. Infections tend to happen in patients who are already very sick, including those with compromised immune systems and people undergoing chemotherapy. While Norris says it will be necessary to wait for the results of the clinical trial, large hospitals are likely to invest in the instrument “if it speeds up the diagnosis of really bad diseases like candidemia.”
T2 Biosystems has raised $30 million in venture funding so far, and is partnering with other companies working on biomarker tests that could be adapted for the magnetic-detection platform. The company will finalize the detection system this summer and will seek approval for the machinery and the Candida test from the U.S. Food and Drug Administration next year.