The FDA announced that it has authorized the first test for Candida auris, an emerging health care-associated fungus that is often resistant to treatment, according to the agency.
C. auris was reported for the first time in the United States in 2016, according to the CDC. Since then, the CDC identified 257 confirmed and 30 probable cases. The European Centre for Disease Prevention and Control reported that the fungus has become a “global health issue,” causing outbreaks in Europe, the U.S., Venezuela, South Africa and India.
The newly authorized test is manufactured by Bruker Daltonik GmbH. It runs on the company’s MALDI Biotyper CA system, which covers 424 other bacteria and yeast species, an FDA release said. The system uses matrix-assisted laser desorption/ionization (MALDI) mass spectrometry technology to identify organisms.
“Although mass spectrometry technology has been a powerful scientific tool since the 1980s, it is only within the last 5 years that it has been effectively used for the identification of microbiological organisms and is now a widely recognized standard of practice for clinical laboratories,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “The FDA has confidence in this technology and recognizes the need to rapidly address outbreaks both for C. auris and for other pathogenic microorganisms to help protect Americans through the recognition and identification of emerging infectious pathogens.”
The marketing authorization is based on an analysis of 28 C. auris isolates, as well as other analytical studies, in which the test correctly identified the pathogen 100% of the time, according to the FDA.
FDA. FDA authorizes new use of test, first to identify the emerging pathogen Candida auris. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605336.htm. Accessed April 20, 2018.
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