FDA allows marketing test to identify yeast pathogens directly from a blood sample

Sept. 24, 2014

The U.S. Food and Drug Administration (FDA) is allowing the first direct blood test for the detection of five yeast pathogens to be marketed in the United States. The yeast pathogens include Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei, which are known to cause bloodstream infections.

Yeast bloodstream infections are a type of fungal infection that can lead to severe complications and death if not treated rapidly. 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) manufactured by T2Biosystems, 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.

“By testing one blood sample for five yeast pathogens and getting results within a few hours, physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness and decrease the risk of dying from these infections,” says Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

T2Candida incorporates technologies that break the yeast cells apart, releasing the DNA. It then makes many copies of the target DNA, and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, T2Candida will also presumptively determine the species category to which it belongs, information that helps to guide healthcare providers to provide appropriate treatment. Learn more about the T2Candida panel.

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