The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei, official website of the Administration says.

Traditional methods of detecting yeast pathogens in the bloodstream can require up to six days, and even more time to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results.

FDA based its review on a clinical study of 1,500 patients, in which T2Candida correctly categorized nearly 100 percent of the negative specimens as negative for the presence of yeast.

In a separate clinical study of 300 blood samples with specific concentrations of yeast, T2Candida correctly identified the organism in 84 to 96 percent of the positive specimens.

T2Candida is manufactured by T2 Biosystems, Inc. in Lexington, Mass.