First Test to ID Candida auris Gets FDA Approval
The Food and Drug Administration (FDA) has permitted the marketing of the Bruker Maldi Biotyper CA system for identification of Candida auris, an emerging pathogen that can cause serious bloodstream infections in hospitalized patients and is often resistant to multiple antifungals.
The FDA reviewed the use of a standard protocol for adding C. auris to the Bruker Maldi Biotyper CA system database along with the performance data of 28 C. auris isolates and other supportive studies. The data showed the Biotyper CA system was able to accurately identify C. auris 100% of the time.
"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," stated 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.
The Bruker Maldi system is already cleared for use in identifying 333 species or species groups, including 424 bacteria and yeast species.
For more information visit FDA.gov.