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Diasorin Secures FDA De Novo Clearance for Candida Auris Detection Assay

NextEdge Admin

16 Jul 2024

1 min 37 sec

Diasorin announced that it has received FDA de novo marketing authorization for its Simplexa C. auris Direct kit, a molecular test designed to identify colonization with Candida auris, a fungal pathogen prevalent in healthcare settings. This real-time PCR assay detects six clades of C. auris DNA from axilla or groin swab samples, providing results in under two hours on the Liaison MDx instrument.

C. auris is known for its ease of transmission within hospitals and poses a significant risk of invasive, life-threatening infections, often showing resistance to first-line antifungal treatments. Both the World Health Organization and the CDC have classified it as a critical fungal pathogen.

Angelo Rago, president of Diasorin's Luminex business, emphasized that this test addresses a crucial need in molecular diagnostics, positioning Diasorin as the first company to offer a PCR-based solution for preventing and controlling C. auris infections in clinical settings. CEO Carlo Rosa highlighted the company’s commitment to developing diagnostic solutions for urgent and emerging health challenges.