NEW YORK – Diasorin said Tuesday that it has received US Food and Drug Administration de novo marketing authorization for a molecular test to identify colonization with Candida auris, a fungal pathogen that is commonly spread in healthcare settings.
The Saluggia, Italy-based firm's Simplexa C. auris Direct kit is a real-time PCR assay that is used for the detection of six clades of C. auris DNA from axilla or groin swab samples of patients with suspected colonization. The test is designed for use on the Liaison MDx sample-to-answer instrument with results in less than two hours.
The firm said that C. auris spreads easily among hospital environments and patients, and colonization increases the risk of invasive and potentially deadly infections. C. auris is often resistant to first-line antifungal drugs, and the World Health Organization and US Centers for Disease Control and Prevention have identified it as a fungal pathogen of critical importance.
Angelo Rago, president of Diasorin's Luminex business, said in a statement that the test kit fills a critical gap in molecular testing and positions Diasorin as the first vendor to commercialize a PCR-based test for the prevention and control of C. auris infections in healthcare settings. Diasorin CEO Carlo Rosa added that the company is focused on identifying diagnostic solutions for urgent, emerging, and relevant clinical conditions as a specialty player in diagnostics.