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FDA Clears New Rapid Test For Candida Infections Of Bloodstream

Yeast bloodstream infections, which are caused by Candida species, are a type of fungal infection, and if untreated, can result in serious medical complications. People who have a weak immune system, or are hospitalized in intensive care units, or have kidney disease needing dialysis, or have had abdominal surgery are said to be at risk of developing yeast bloodstream infections.

There are over 20 species of Candida yeasts that can cause infection in humans. Of these, the more important pathogenic species include Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata and Candida krusei and Candida lusitaniae.

The traditional approaches to detect yeast pathogens in the bloodstream are tedious and time-consuming. The current gold standard of blood culture requires up to six days, and even more time to identify the specific type of yeast present, according to the FDA. But that's all about to change as a new, rapid diagnostic test for Candida infections of the bloodstream, developed by privately-held T2 Biosystems Inc., has received regulatory clearance.

T2 Biosystems' T2Candida test, which has received FDA clearance, can detect five common yeast pathogens that cause bloodstream infections - Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei - directly from an unpurified blood sample as fast as three hours.

According to the company, T2Candida is designed to provide species-specific identification directly from whole blood and without the need for blood culture. However, because of the possibility of false-positive results, physicians should perform blood cultures to confirm T2Candida results, the FDA noted.

Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health said, "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."

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