FDA Clears First Test for Emerging Pathogen Candida auris

Megan Brooks


April 23, 2018

The US Food and Drug Administration (FDA) has authorized use of the Bruker Maldi Biotyper CA system (Bruker Daltonik GmbH) to identify Candida auris, an emerging and often multidrug-resistant fungus that is causing invasive infections in hospitalized patients in the United States and other countries. C auris infections are associated with high mortality.

The Bruker Maldi system is already authorized for identification of 333 species or species groups, covering 424 clinically relevant bacteria and yeast species.

The 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 findings show that the system can reliably identify C auris 100% of the time, the agency said.

"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," the FDA said in a news release.

The Bruker Maldi Biotyper CA system uses matrix-assisted laser desorption/ionization mass spectrometry in combination with a reference organism database.

"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," Donald St. Pierre, acting director, Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health, said in the release.

"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 St. Pierre.

A Serious Global Health Threat

C auris is a "serious global health threat" the US Centers for Disease Control and Prevention (CDC) said April 20 in an update on the threat of C aurus in the United States. Colonies of C auris can persist in patients for a long time, and C auris can persist on surfaces in healthcare environments, leading to its spread among patients in healthcare facilities.

As of March 31, there were 257 confirmed clinical cases and 30 probable cases of C auris infection in the United States. Most confirmed clinical cases were in New York (155 cases), New Jersey (59), and Illinois (25). Most probable cases were in New Jersey (23), the agency said.

In addition to the clinical case counts, 475 patients in four states have been found to be colonized with C auris by targeted screening, according to the CDC.

The CDC has alerted US healthcare facilities to be on the lookout for C auris in their patients and has begun prevention and education efforts targeted toward healthcare staff and laboratories that identify C auris.

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