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FDA Approves First Test to Identify Yeast Pathogens in Blood Sample

Clinicians get results within hours

The FDA has allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans, C. tropicalis, C. parapsilosis, C. glabrata, and C. krusei.

Yeast bloodstream infections are a type of fungal infection that can lead to severe complications and even death if not treated rapidly. These yeast pathogens may cause serious bloodstream infections in people with weakened immune systems, including patients undergoing cancer treatment, receiving immunosuppressive therapy following an organ transplant or severely ill patients in intensive-care units.

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 T2Candida Panel and T2Dx Instrument (T2 Biosystems, Inc.) can identify these five common yeast pathogens from a single blood specimen within 3 to 5 hours. Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida test, 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,” said Dr. Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

The T2Candida test incorporates technologies that break the yeast cells apart, releasing the DNA. It then makes copies of the target DNA and detects the amplified DNA using magnetic resonance technology. If yeast DNA is found, the test will also presumptively determine the species category to which it belongs — information that will help guide health care providers in providing appropriate treatment.

The FDA’s approval was based on a clinical study of 1,500 patients, in which the T2Candida test correctly categorized nearly 100% of the negative specimens as negative for the presence of yeast.

In a separate clinical study of 300 blood samples with specific concentrations of yeast, the T2Candida test correctly identified the organism in 84% to 96% of the positive specimens.

Source: FDA; September 22, 2014.

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