Diasorin launches the Simplexa C. auris Direct assay on the LIASON MDX instrument in all countries accepting the CE mark
The assay is designed to improve infection control in healthcare settings through the rapid identification of patients suspected of Candida auris colonization
19 Mar 2025
The Simplexa™ C. auris Direct assay:
- Aids in the prevention and control of Candida auris, a rapidly emerging multidrug-resistant fungal pathogen commonly found in healthcare settings
- Is a real-time polymerase chain reaction assay run on the LIAISON® MDX instrument, with minimal sample preparation and results in less than 2 hours with excellent clinical performance
- Is available in all countries accepting the CR mark in accordance with IVD regulation 2017/746
Diasorin announces the launch of its Simplexa™ C. auris Direct kit in all countries accepting the CE mark. The assay aids in the identification of patients suspected of Candida auris colonization to enable infection control in healthcare settings, and prevent potentially deadly infections in vulnerable patients.
This real-time polymerase chain reaction (RT-PCR) assay is used for the direct in vitro qualitative detection of C. auris DNA from a composite swab of axilla/groin from patients suspected of C. auris colonization, and detects all six C. auris clades identified globally. This targeted molecular diagnostic test is performed on the LIAISON® MDX, yielding patient results in less than two hours with excellent clinical performance.
C. auris is a global challenge for healthcare facilities since asymptomatically colonized patients can easily spread the fungus in hospital environments and to other patients. Furthermore, patient colonization is a known risk factor for invasive infections that are associated with high mortality rates.
C. auris infections are known to be resistant to one or more classes of antifungal drugs. Because of this, the World Health Organization, U.S. Center for Disease Control and Prevention, and European Centre for Disease Prevention and Control have all identified it as a fungal pathogen of critical importance.
Responsible for outbreaks in more than 35 countries over the last decade and emerging as a significant healthcare concern, C. auris is considered to be an urgent antimicrobial resistance threat. Therefore, screening to identify colonized patients is key to implementing timely contact precautions and infection control measures to limit the spread of the organism within healthcare facilities and to prevent outbreaks.
“Diasorin is committed to developing impactful diagnostic solutions to combat deadly and emerging infections,” said Angelo Rago, President of Luminex. “The Simplexa™ C. auris Direct kit fills a much-needed gap in C. auris molecular detection and will help to empower labs to easily, accurately, and rapidly control and prevent Candida auris infections in healthcare settings.”
