NEW YORK (GenomeWeb) – DiaSorin announced on Tuesday that the US Food and Drug Administration has provided 510(k) clearance of the firm's Simplexa C. difficile Direct Assay for marketing in the US.
The assay has been available outside the US since November and runs on DiaSorin's Liaison MDX benchtop instrument, which provides clinically validated, real-time PCR results, the Italian in vitro diagnostic firm said in a statement.
Citing statistics from the US Centers for Disease Control and Prevention, DiaSorin said that about 15,000 C. difficile-related deaths occur in the US annually, and added that the bacteria is the most common microbial cause of US hospital-associated infections.
The launch of the assay in the US "allows us to strengthen our positioning as a reliable infectious diseases company in a market where we see interesting growth opportunities," DiaSorin CEO Carlo Rosa said in a statement. "Our new assay is able to address the needs of hospital laboratories in regards to workflow and lab efficiency and have a positive impact on identifying C. difficile, leading to improved patient management."