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FDA Clears Bruker's MALDI Biotyper for Candida ID

NEW YORK (360Dx) – Bruker said after the close of markets on Friday that the US Food and Drug Administration had cleared use of the company's MALDI Biotyper system for the detection of Candida auris.

According to Bruker, the MALDI Biotyper is now cleared by FDA for the clinical identification of 333 species or species groups covering 424 bacteria and yeast species.

A yeast, C. auris is a cause of infections in settings like hospitals and can be resistant to antifungal drugs typically used to treat Candida infections.

"Although mass spectrometry technology has been a powerful scientific tool since the 1980s, it is only within that the last five 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 a statement. "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."