CDC-Candida auris culture_21796

FDA has authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients. C. auris  is a yeast that can cause serious bloodstream infections and is frequently resistant to multiple antifungal drugs used to treat Candida infections.

Specifically, FDA has granted premarket notification (510(k)) clearance for a new use of the Bruker MALDI Biotyper CA system from Bruker Daltonik GmbH, Hamburg, Germany, for the identification of C. auris, adding to the system’s already cleared uses for the identification of 333 species or species groups, covering 424 clinically relevant bacteria and yeast species.

The Bruker MALDI Biotyper CA system uses matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry in combination with a reference organism database. Microorganisms cultured from patient samples are ionized by the laser to produce an organism spectrum, which is matched to the reference organism database for proper identification.

Availability of a device that reliably identifies a wide-range of pathogens is important for the timely identification of microorganisms associated with emerging outbreaks and also improves laboratory productivity and patient care.

“Although mass spectrometry technology has been a powerful scientific tool since the 1980s, it is only within that 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,” says Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.

“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,” adds St. Pierre.

FDA plans to propose exempting certain mass spectrometry microorganism identification system processes from additional premarket review after a system process receives a first-time FDA marketing authorization. A proposed exemption of this kind would further meet the need for updates to device-specific organism databases and enable mass spectrometry devices to expand their microorganism identification capabilities in the least burdensome manner.

FDA evaluated the use of a standard protocol for adding C. auris to the Bruker MALDI Biotyper CA system database in conjunction with the performance data of 28 C. auris isolates and other supporting analytical studies. The agency’s findings indicated the system can reliably identify C. auris 100% of the time.

Risks associated with use of the system may include no identification or misidentification of a microorganism. C. auris isolates were obtained from various culture collections, including the antibiotic resistance isolate bank maintained by FDA and the Centers for Disease Control and Prevention.

FDA’s action was taken through the de novo premarket review pathway, a regulatory pathway for novel, low- to moderate-risk devices that are not substantially equivalent to an already legally marketed device. Marketing authorization was granted to Bruker Daltonik GmbH.

For more information, visit Bruker.

Featured image: Candida auris culture; photo by Shawn Lockhart courtesy US Centers for Disease Control and Prevention.