On Apr 20 the FDA announced that it was permitting the Bruker MALDI Biotyper CA System to be marketed for the identification of C. auris, which first appeared in the United States in 2016 and to date has been detected in 287 US patients, with 257 cases confirmed, according to the Centers for Disease Control and Prevention (CDC).
The yeast causes severe infections in hospitalized patients, is associated with high mortality, and is difficult to identify with standard laboratory methods. Misidentification can lead to inappropriate management of infections and allow the pathogen to spread.
Results in under an hour
The test, first approved by the FDA in 2013, uses a technology known as matrix-assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometry to determine the unique protein fingerprint of a microorganism cultured from a patient, then matches those fingerprints to a reference organism database to identify 424 clinically relevant bacteria and yeast species. MALDI-TOF can provide results in less than an hour, while conventional methods of species identification usually take 24 to 48 hours.
"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," Donald St. Pierre, acting director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a news release.
The approval was based on performance data for 28 C. auris isolates and other supporting analytical studies, according to the release. The findings indicated that the system can reliably identify C. auris 100% of the time.
C. auris was first identified in the ear of a Japanese patient in 2009 and since then has spread to several other countries and emerged as a global health threat. Most of the strains in the United States have been linked to patients who had recently received healthcare in a country where C. auris has been reported.
The fungus has shown varying levels of resistance to all three major classes of antifungal medications used to treat Candida infections (azoles, echinocandins, and polyenes), making it extremely difficult to treat, and it can spread within hospital settings.