(Alliance News) - Diasorin Spa announced Tuesday that it has received "de-novo" approval from the U.S. Food and Drug Administration for the Direct Simplexa C. auris kit indicated for diagnosis on patients with suspected Candida auris colonization.

The test, which applies the real-time polymerase chain reaction technique, is used for direct in vitro qualitative detection of C. auris DNA from axillary/inguinal swabs of patients with suspected colonization and is capable of identifying the six globally circulating groups of C. auris.

Simplexa C. auris can be performed on the Liaison MDX molecular diagnostics platform, Diasorin's easy-to-use, rapid analyzer that delivers results in less than two hours.

Candida auris poses a challenge to healthcare facilities because patients can be colonized by it asymptomatically, thus causing the pathogen to spread easily in hospital environments and among patients. Colonization is a known risk factor for invasive infections with which high mortality rates are associated in the most severe forms. The pathogen is continually emerging, often not responding to antifungal drugs commonly used for Candida, and for this reason, the World Health Organization and the U.S. Centers for Disease Control and Prevention have identified it as a priority fungal pathogen.

Candida auris has been responsible for outbreaks in more than 35 countries over the past decade and is an increasingly emerging and significant health problem, partly because of its antimicrobial resistance. Screening to identify patients colonized by the pathogen is, therefore, critical for timely implementation of infection control measures, limiting its spread within healthcare facilities and thus preventing potential epidemic outbreaks.

"The FDA's 'de-novo' approval of our new test for Candida auris fills a very important gap in molecular detection of the pathogen, once again positioning Diasorin as the premier molecular diagnostics player in providing a test to help prevent and monitor potentially very dangerous infections," said Angelo Rago, president of Luminex.

"Our new test is the first on the market with low complexity and rapid execution and will enable laboratories to obtain accurate diagnostic results in the management of patients with suspected C. auris infection."

Carlo Rosa, CEO of Diasorin, commented, "The launch of this new molecular diagnostic test confirms our positioning as a Diagnostic Specialist and our continued commitment to providing laboratories with innovative diagnostic solutions to address complex, emerging and increasingly relevant clinical conditions."

By Giuseppe Fabio Ciccomascolo, Alliance News senior reporter

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