FDA Approved marketing Of a Test to Detect Five Different Pathogenic yeasts

The marketing of a new test has approved by U.S. Food and Drug Administration (FDA) that will use blood to identify five different pathogenic yeasts namely Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.

Patient could suffer severe complications and sometimes die if untreated due to mycosis (fungal infection) in blood caused by above mentioned yeasts. Such types of infections could occur more frequently in patients:

1. Whose immune system is weak
2. Undergoing chemotherapy
3. Using immunosuppressants or admitted in ICU (intensive care unit).

Nearly six days were needed to detect yeast pathogens in bloodstream by using traditional methods. Now it is possible by T2Candida Panel and T2Dx Instrument (T2Candida) to identify five different above mentioned yeast pathogens by using single blood sample within three to five hours. Since false positive results could arise from T2Candida so culture test should be performed for confirmation.  

Blood test (Photo credit: Flickr)

“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.

Manufactured By:

T2Candidia is being manufactured by T2 Biosystems, Inc. in Lexington, Mass.

Reference:

FDA News Release