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Meridian Bioscience Campylobacter Assay Receives FDA Clearance

NEW YORK – Meridian Bioscience announced on Wednesday that its Curian Campy assay for the detection of Campylobacter infection has received clearance from the US Food and Drug Administration. 

The rapid immunoassay detects a Campylobacter-specific antigen found in C. jejuni, C. coli, C. upsaliensis, and C. lari in human fecal samples and runs on the Curian immunofluorescent testing platform, returning results in approximately 20 minutes, the company said in a statement. 

Campylobacter is a Gram-negative bacteria that is the most common cause of diarrheal illness in the US, and it infects about 1.5 million people per year, according to the US Centers for Disease Control and Prevention.

Curian Campy is the second FDA-approved test for Curian — the platform received FDA clearance in March 2020, along with the Curian HpSA test for Helicobacter pylori. Meridian submitted Curian Campy to the FDA in April.

"Curian Campy follows last year's successful launch of our Curian HpSA assay and is the next step in expanding our Curian test menu for gastrointestinal infections," Wes Lindsey, VP of global research and development for diagnostics. "What is most exciting about this platform is that it paves the way for us to continue to develop easy-to-use lateral flow assays with fluorescent detection on an automated analyzer. This allows for not only increased sensitivity but eliminates the subjectivity that is inherent when manually reading a lateral flow assay."