miércoles, 25 de abril de 2018

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>

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update



What are MCMs?


(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 infographic available at: http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/AboutMCMi/ucm431268.htm#infographic

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


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





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.”


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


EUA updates
Emergency Use Authorization, with emergency sign



EUA amendment
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.


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