FDA Allows Marketing of First Test to Identify 5 Yeast Pathogens Directly From a Blood Sample

PRESS RELEASE

The U.S. Food and Drug Administration today allowed marketing in the U.S. 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—they 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 six days, and even more time 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. 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.

“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 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 FDA reviewed T2Candida through its de novo classification process, a regulatory pathway for certain novel low- to moderate-risk medical devices.

FDA based its review on 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.