NEW YORK – Diasorin said Tuesday that it has received CE marking under the EU's In Vitro Diagnostic Regulation for a molecular test to detect the fungal pathogen Candida auris, a common source of healthcare setting-associated infections.
The Saluggia, Italy-based firm said that the Simplexa C. auris Direct kit is a real-time PCR assay that is used for the detection of DNA from six clades of the fungal pathogen in a composite axilla/groin swab sample from patients with suspected colonization, with results within two hours. The test is designed for use on the company's Liaison MDX instrument.
Diasorin said that the test can be used to help control the spread of infections in healthcare settings, including potentially deadly infections among vulnerable patients. Asymptomatic patients may be colonized with C. auris, which can spread between hospitalized patients and is a risk for invasive infections. The firm also noted that multidrug-resistant C. auris is an emerging threat.
The firm last year also secured US Food and Drug Administration de novo marketing authorization for the Simplexa C. auris Direct kit. Last week, Diasorin CEO Carlo Rosa said in a conference call related to the company's FY 2024 earnings that the successful US launch of the assay had contributed to growth in the firm's molecular diagnostics revenues.