The first blood test to detect five strains of yeast that cause rare blood infections in people with weakened immune systems has been approved by the U.S. Food and Drug Administration.
The five types of yeast pathogen detected by the T2Candida test can cause deadly bloodstream infections if not treated quickly, the FDA said in a news release. People at greatest risk of the infections include those being treated for cancer, those who have been given immune system-suppressing drugs after an organ transplant and severely ill people in intensive care.
Results from the new test are available in three to five hours, compared to six days or longer from traditional methods, the FDA said. The faster results may allow doctors to begin treatment sooner.
But since false positives are possible from the new test, results should be confirmed by blood culture, the agency advised.
The new test was evaluated in clinical studies of about 1,800 people. Negative results were correctly identified nearly 100 percent of the time, and the yeast organism involved was correctly identified in 84 percent to 96 percent of positive specimens, the FDA said.
The T2Candida test is produced by T2 Biosystems, based in Lexington, Mass.