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FDA Allows Marketing of Direct Blood Test to Identify 5 Yeast Pathogens

First Posted: Sep 24, 2014 07:17 AM EDT

The FDA panel has approved the marketing of the first direct blood test to detect the five yeast pathogens that trigger bloodstream infections.

Yeast bloodstream infection is a type of fungal infection that can cause severe complications and even death if not treated immediately. They are also known to cause serious bloodstream infections in those with weakened immune systems including patients receiving cancer treatment, immunosuppressive therapy after an organ transplant or the extremely ill patients kept in the intensive care units (ICU).

Currently, the health experts detect yeast pathogens in the bloodstream using traditional methods that require up to six days plus extra time to recognize the specific type of yeast. But now, the U.S. Food and Drug Admiration has allowed the marketing of T2Dx Instrument (T2Candida) that detects the five common yeast pathogens from a single blood specimen within three to five hours.

The five yeast pathogens causing infections are Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.

Since yeast bloodstream infections are uncommon and there is a possibly of false positive result with T2Candida, the physicals should conduct blood cultures to confirm the 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," said Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health. 

T2Candida applies the technology that breaks the yeast cells apart, releasing the DNA. It then replicates several copies of the target DNA and detects the amplified DNA with the help of magnetic resonance technology. If yeast DNA is detected, T2Candida will also presumptively determine the category to which the species belongs. This data will guide health experts in providing the apt treatment.

T2Candida was reviewed through the de novo classification process. The safety and efficacy of the test was reviewed through a clinical study that included 1500 patients in which T2Candida correctly categorized up to 100 percent of the negative specimens as negative for the presence of yeast.

In another clinical study, they looked at 300 blood samples that had specific concentrations of yeast; T2Candida had correctly detected the organism in 84-96 percent of the positive specimens.

T2Candida is manufactured by T2 Biosystems.

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