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Luminex Receives FDA Clearance for C. Diff Assay

NEW YORK (GenomeWeb) – Luminex said today that the US Food and Drug Administration has given 510(k) clearance for the firm's Aries C. difficile assay — a moderate complexity, sample-to-answer test for rapid detection of Clostridium difficile, which has become a common microbial cause of healthcare-associated infections in US hospitals.

In testing for C. difficile, the real-time PCR assay running on the Aries system detects both toxin A and toxin B, which may reduce the probability of a false negative result from strains that only produce toxin A, the firm said. 

"With this regulatory approval, we are further broadening our infectious diseases testing portfolio and adding to our rapidly growing menu of targeted assays and customized panels," Luminex President and CEO Homi Shamir said in a statement.

Earlier this year, Luminex received regulatory clearances for additional assays on Aries, including FDA clearances for Bordetella and Group B Streptococcus, and CE marking for Norovirus.

Ray Widen, scientific director of esoteric testing and R&D at Tampa General Hospital, said that the Aries C. difficile assay "was easy to use and performed very well in our lab during the clinical trial." He added that a combination of attributes — including a simple workflow for ease of training, sample in-answer out capabilities, and rapid time-to-result — makes the Aries system a good fit for routine microbiology laboratories "that may not have prior experience with molecular assays."

Citing a 2015 Centers for Disease Control and Prevention study, Luminex said that C. difficile caused almost half a million infections and 15,000 deaths among US patients in a single year.