The FDA authorized the first test April 20 to identify emerging pathogen Candida auris, which can lead to serious infections in hospitalized patients.
In particular, the agency approved marketing for a new use of the Bruker MALDI Biotyper CA system for identifying C. auris. The newly approved use adds to the system's cleared uses for identifying over 300 species or species groups, which covers 424 clinically relevant bacteria and yeast species.
C. auris is a yeast that can cause serious infections, including bloodstream infections, in hospitalized patients. C. auris is often resistant to multiple antifungal drugs used to treat Candida infections.
The system uses a technology known as matrix-assisted laser desorption/ionization mass spectrometry combined with a reference organism database, according to the FDA. A laser ionizes microorganisms cultured from patient samples to create an organism spectrum, which is then matched to the reference organism database to properly identify the microorganism.
"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," said 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.