Diasorin receives FDA de-Novo grant for the Simplexa C. auris Direct assay on the LIAISON MDX instrument

Diasorin announced that the Food and Drug Administration (FDA) has granted de-novo authorization for the Simplexa C. auris Direct kit to test patients suspected of Candida auris colonization and aid in preventing potential spread in healthcare settings.

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.

Diasorin release