FDA Authorizes C. auris Detection Assay

The FDA authorized marketing of DiaSorin Molecular LLC’s Simplexa C. auris Direct, a molecular-based assay intended to detect Candida auris (C. auris) DNA from a skin swab of the armpit or groin from patients suspected of C. auris colonization. The test is intended to help prevent and control C. auris infections in healthcare settings. Read more about FDA’s role in combating antimicrobial resistance.