First direct Candida blood test is cleared by FDA.
FROM THE FDA
A blood test that identifies five Candida species directly from one blood sample, with results in 3-5 hours, has been cleared for marketing by the Food and Drug Administration, the agency announced.
The T2Candida Panel tests for Candida albicans and/or C. tropicalis, C. parapsilosis, C. glabrata, and/or C. krusei, and is the first test that identifies these pathogens directly from a single specimen, the FDA said in the statement announcing the authorization. "Traditional methods of detecting yeast pathogens in the bloodstream can require up to 6 days, and even more time to identify the specific type of yeast present," the statement notes.
"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," Dr. Alberto Gutierrez, director of the office of in vitro diagnostics and radiological health at the FDA's Center for Devices and Radiological Health, said in the statement.
Approval was based on a study of 1,500 patients. In the study, the test correctly identified almost 100% of the negative blood specimens as negative for Candida, and in another study of 300 blood samples that contained specific concentrations of Candida species, the test correctly identified the Candida species in 84%-96% of the specimens that were positive, according to the FDA statement. Blood cultures are required to confirm the results.
The test is manufactured by T2Biosystems, which also manufactures the T2Dx Instrument; together, the two are referred to as "T2Candida."
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|Title Annotation:||FDA NEWS|
|Publication:||OB GYN News|
|Date:||Oct 1, 2014|
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