The FDA will now permit marketing of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.
Yeast bloodstream infections are a type of fungal infection which, if not treated quickly, can lead to severe complications and even death if not treated rapidly, particularly 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.
Most people are familiar with Candida as a yeast-like fungus that grows primarily in the vagina, resulting in a condition more commonly referred to as vaginitis. Women with this condition should also be checked for diabetes. However, candida can infect other parts of the body as well, such as ears, nose, gastro-intestinal tract and the mouth (leaving white spots on the tongue, gums and inner cheek). The later is usually referred to as “thrush.”
Depending on just how severe the infection is, additional symptoms can include either constipation or diarrhea, colitis, abdominal pains, sore throat, achy joints and muscles, arthritis, kidney and bladder infections, persistent cough, numbness in one’s limbs and canker sores. Suffers may also experience mood swings from hyper-activity to depression.
While “traditional” methods of detecting yeast pathogens in the bloodstream can require up to 6 days or more 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 3-5 hours by “breaking the yeast cells apart to release the DNA, then making numerous copies of the target DNA, which are subsequently amplified 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 proper treatment.
“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,” stated Alberto Gutierrez, director of the Office of In-Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, who went on to add that, “Because yeast bloodstream infections are uncommon, and because false positive results are possible with the T2Candida, physicians should perform blood cultures to confirm T2Candida results.”