Press Announcements > FDA authorizes new use of test, first to identify the emerging pathogen Candida auris

Press Announcements > FDA authorizes new use of test, first to identify the emerging pathogen <i>Candida auris</i>

What are MCMs?

Learn more about medical countermeasures (MCMs)—or help others learn—with our new infographic(PDF, 251 KB).

Image: (part of infographic) Medical countermeasures, or MCMs, are FDA-regulated products that may be used in a public health emergency stemming from a terrorist attack with or accidental release of a biological, chemical, or radiological/nuclear agent, or a naturally occurring emerging infectious disease. Full text description of entire infographic.

FDA authorizes new use of test

First to identify the emerging pathogen Candida auris

On April 20, 2018, FDA authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients. C. auris is a yeast that can cause serious infections in hospitalized patients (e.g., bloodstream infections) and is frequently resistant to multiple antifungal drugs used to treat Candida infections.  “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,” said 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 (CDRH). “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.”

Related links:  General information about C. auris from CDC C. auris fact sheet (CDC)  Tracking C. auris - maps showing U.S. and worldwide cases (CDC) Recommendations for Infection Prevention and Control for C. auris (CDC)

Image: A strain of C. auris cultured in a petri dish at CDC. (Credit: Shawn Lockhart/CDC)

EUA updates

EUA amendment

April 16, 2018: CDC Zika MAC-ELISA -  In response to CDC's request, FDA concurred with modifications to the authorized Instructions for Use labeling  - Additional technical information, including updated labeling

Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer. Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.

In case you missed it Did you know? Generics work the same as brand-name medicines. Find out why. Statement from FDA Commissioner Scott Gottlieb, MD, on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation - also see Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health (PDF, 10 MB) (April 17, 2018) Learn why diversity in clinical research is important by listening to FDA Office of Minority Health's new podcast (video, 17 minutes) featuring U.S. Army veterans discussing clinical trials. (April 2018) From HHS - HHS purchases anthrax antitoxin for Strategic National Stockpile - Acquisition augments anthrax treatments currently stockpiled (April 23, 2018) From CDC - CDC released its 10th annual preparedness report, the Public Health Preparedness and Response 2018 National Snapshot. The Snapshot highlights preparedness activities and investments at the federal, state, and local levels, and features stories that demonstrate the impact of these activities. (April 16, 2018) From CDC/NIOSH - Filtering out Confusion: Frequently Asked Questions about Respiratory Protection - The National Personal Protective Technology Laboratory (NPPTL), part of the National Institute for Occupational Safety and Health (NIOSH) has released new fact sheets on respirator fit testing, user seal check, and respirator reuse and extended use. (April 9, 2018) From HHS ASPR - Decontamination Decoded: Disrobing, Dry Wiping Removes 99% of Chemical Contaminants - ASPR’s Biomedical Advanced Research and Development Authority (BARDA) sponsored a set of scientific studies on chemical decontamination. The results of these studies, codified as the Primary Response Incident Scene Management (PRISM) Guidance for Chemical Incidents, will help local emergency management planners and first responders prepare for and respond to disasters involving chemical agents. (April 11, 2018)