FDA Green Lights First Candida Auris Test

The US Food and Drug Administration (FDA) has announced the approval of the first test to identify the emerging pathogen Candida auris (C. auris), which has been found to cause serious infections in hospitalized patients, the BRUKER MALDI Biotyper CA system.

The Bruker Daltonik GmbH system is currently cleared by the agency for the identification of 333 species or species groups, including 424 bacteria and yeast species relevant to clinical use. C. auris is frequently resistant to multiple antifungal therapies used for treating Candida infections.

It was evaluated with the standard protocol of adding C. auris to the system’s database in conjunction with the performance data of 28 C. auris samples, as well as additional supporting analytical studies. The study findings indicated that the system was able to identify the pathogen 100% of the time.

The action by the FDA was made through the De Novo premarket review pathway, which involves low-to-moderate risk devices that are not substantially equivalent to already marketed devices. Risks associated with the system do, however, include no identification or misidentification.

The Biotyper CA system utilizes a matrix-assisted laser desorption/ionization (MALDI-TOF) mass spectrometry in combination with an organism database for reference. The identification of the cultures is important to addressing emerging outbreaks as well as productivity in the laboratory and patient care.

“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, the 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.”

The FDA is planning to propose the exemption of certain mass spectrometry microorganism identification system processes from additional premarket reviews after the system has received its first-time FDA marketing authorization, according to the agency.