FDA News

FDA allows marketing of first test for yeast pathogens

The FDA is allowing the marketing of the first direct blood test for five different yeast pathogens responsible for bloodstream infections, according to a press release.

The T2Candida (T2 Biosystems Inc.) can detect Candida albicans, C. tropicalis, C. parapsilosis, C. glabrata and/or C. krusei within 3 to 5 hours from a single blood specimen. Traditional methods can take up to 6 days to detect yeast pathogens in the bloodstream and even longer to identify the specific type of yeast causing infection.

“By testing one blood sample for five yeast pathogens — and getting results within a few hours — physicians can initiate appropriate antifungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiologic health at the FDA’s Center for Devices and Radiological Health, said in the release.

Alberto Gutierrez 

Alberto Gutierrez

The T2Candida utilizes technology that breaks apart yeast cells, releasing DNA. Once copies of the target DNA are made, the test uses magnetic resonance to detect the amplified DNA. If yeast DNA is detected, the T2Candida will presumptively determine its species, which can help direct appropriate treatment.

The FDA based its decision on a clinical study of 1,500 patients. The T2Candida correctly identified 100% of the negative specimens as negative for the presence of yeast. In another study of 300 blood samples with specific concentrations of yeast, the test correctly identified the organism in 84% to 96% of the positive specimens.

Because the test can produce false-positive results, the FDA recommends that physicians should perform blood cultures to confirm results.

The FDA is allowing the marketing of the first direct blood test for five different yeast pathogens responsible for bloodstream infections, according to a press release.

The T2Candida (T2 Biosystems Inc.) can detect Candida albicans, C. tropicalis, C. parapsilosis, C. glabrata and/or C. krusei within 3 to 5 hours from a single blood specimen. Traditional methods can take up to 6 days to detect yeast pathogens in the bloodstream and even longer to identify the specific type of yeast causing infection.

“By testing one blood sample for five yeast pathogens — and getting results within a few hours — physicians can initiate appropriate antifungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” Alberto Gutierrez, PhD, director of the office of in vitro diagnostics and radiologic health at the FDA’s Center for Devices and Radiological Health, said in the release.

Alberto Gutierrez 

Alberto Gutierrez

The T2Candida utilizes technology that breaks apart yeast cells, releasing DNA. Once copies of the target DNA are made, the test uses magnetic resonance to detect the amplified DNA. If yeast DNA is detected, the T2Candida will presumptively determine its species, which can help direct appropriate treatment.

The FDA based its decision on a clinical study of 1,500 patients. The T2Candida correctly identified 100% of the negative specimens as negative for the presence of yeast. In another study of 300 blood samples with specific concentrations of yeast, the test correctly identified the organism in 84% to 96% of the positive specimens.

Because the test can produce false-positive results, the FDA recommends that physicians should perform blood cultures to confirm results.