FDA Authorizes First Test to Detect Candida auris

The US Food and Drug Administration (FDA) has authorized the first test to identify Candida auris, a fungus that is known to cause serious, sometimes life-threatening infections.

First reported clinically as an isolate from the ear of a patient in a Japanese hospital back in 2009, the yeast continued to spread on a global scale, mainly as a bloodstream infection.

“C. auris is not easily identified. You need [matrix-assisted laser desorption/ionization-time of flight mass spectrometry] or DNA sequencing. It’s unfortunately easily transmitted. It’s on our skin so it can readily contaminate healthcare environments. It’s difficult to treat because of the multi-drug resistance, and it causes severe infections like invasive candidiasis,” said Tom Chiller, MD, MPH, chief of the Mycotic Diseases Branch, Centers for Disease Control and Prevention (CDC).

The FDA has permitted marketing for a new use of the BRUKER MALDI Biotyper CA system, which identifies microorganisms using MALDI-TOF mass spectrometry to determine the unique protein fingerprint of an organism, according to the official company website. The system has already been cleared for use in identifying over 333 species or species group, but now, C. auris has been added to the list.

How does the system work? It combines mass spectrometry with a reference organism database. First, microorganisms are cultured from patient samples and ionized via a laser to produce an organism spectrum. To properly identify the organism, this is matched to the reference organism database.

"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, 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 recent 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."

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The FDA assessed the use of a standard protocol for adding C. auris to the system, looked at performance data pertaining to 28 C. auris isolates that had been collected, and also reviewed other supporting analytical studies. They came to the conclusion that the system was able to identify the fungus 100% of the time. However, there are some known risks associated with the system; these can include no identification or even misidentification of a microorganism.

The FDA plans to “propose to exempt certain mass spectrometry microorganism identification system processes from an additional premarket review after a system process receives a first-time FDA marketing authorization (e.g., 510(k) clearance).” This would help enable mass spectrometry devices to expand their identification capabilities “in the least burdensome manner.”