Summary: The FDA granted de-novo authorization for Diasorin’s Simplexa C. auris Direct kit, an RT-PCR assay for the rapid detection of Candida auris DNA.
- Rapid Detection: The Simplexa C. auris Direct kit provides results in less than two hours, significantly faster than traditional methods, enabling quicker implementation of infection control measures.
- Comprehensive Detection: This RT-PCR assay detects all six global clades of Candida auris from patient swabs, making it a versatile tool for healthcare facilities worldwide.
- Enhanced Infection Control: By identifying asymptomatic colonization, the kit helps prevent the spread of C. auris in healthcare settings, addressing a major challenge posed by this antifungal-resistant pathogen.
The Food and Drug Administration (FDA) has granted de-novo authorization for Diasorins’ Simplexa C. auris Direct kit to test patients suspected of Candida auris colonization and aid in preventing potential spread in healthcare settings.
New Method to Detect Candida Auris
This real-time polymerase chain reaction (RT-PCR) assay is used for the direct in vitro qualitative detection of C. auris DNA from a swab of axilla/groin from patients suspected of C. auris colonization, and detects the six C. auris clades that are circulating globally.
Run on the LIAISON MDX, the easy-to-use, sample-to-answer system has a streamlined workflow yielding results in less than two hours.
C. auris is a challenge for healthcare facilities since patients may be asymptomatically colonized, and it spreads easily in hospital environments and to other patients. Its colonization is a known risk factor for invasive infections which are associated with high mortality rates. C. auris continues to emerge and often does not respond to commonly used antifungal drugs. Because of this, the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) have identified C. auris 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. Traditional methods take several days to get results and often need to be sent out to a reference lab.
“The FDA de-novo authorization for the Simplexa C. auris Direct kit fills a much-needed gap in C. auris molecular detection and uniquely positions Diasorin as the first molecular diagnostic vendor to commercialize a PCR test for the prevention and control of Candida auris infection in healthcare settings,” says Angelo Rago, president of Luminex. “This de-novo molecular test is the first easy, fast, and moderate complexity assay empowering laboratories with diagnostic confidence in managing patients with suspected of C. aurisinfection, thereby promoting better patient outcomes.”
Further reading: Diasorin’s Blood Culture Yeast Assay Receives FDA 510(k) Clearance
“With the launch of this new product in the field of molecular diagnostics, we confirm our strong position as a company focused on identifying diagnostic solutions for urgent, emerging and relevant clinical conditions through our positioning as a specialty player in diagnostics,” says Carlo Rosa, CEO of Diasorin.
