The U.S. Food and Drugs Administration has approved the first direct blood test for detection of five yeast pathogens that cause bloodstream infections.
These infections include Candida albicans, Candida tropicalis, Candida parapsilosis, Candida glabrata and Candida krusei. These can lead to severe complications and even death if not treated rapidly. These yeast pathogens can 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. Current methods to detect yeast pathogens in the bloodstream require up to six days to identify the specific type of yeast present. The T2Candida Panel and T2Dx Instrument (T2Candida) can identify these five common yeast pathogens from a single blood specimen within three to five hours.
"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 in a press statement. "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 health care providers to provide appropriate treatment."
The effectiveness and safety of the test was evaluated in a clinical study of 1,500 patients, in which T2Candida correctly categorized nearly 100 percent 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, T2Candida correctly identified the organism in 84 to 96 percent of the positive specimens.
T2Candida is manufactured by T2 Biosystems, Inc. in Lexington, Mass.
