NEW YORK – Meridan Bioscience announced Thursday it has submitted an assay for the detection of campylobacter species to the US Food and Drug Administration for 510(k) clearance.
The assay, called Curian Campy, detects campylobacter species C. jejuni, C. coli, C. upsaliensis, and C. lari in stool samples preserved in Cary-Blair-based transport media or unpreserved.
Curian Campy runs on Meridian's Curian rapid fluorescent immunoassay instrument that was cleared by the FDA last year together with an assay for H. pylori. The instrument has a small footprint with a three-step workflow requiring one minute of hands-on time.
In a statement, Meridian noted that the assay is one of many in the pipeline to expand the Curian menu, which is centered in its expertise and proprietary core technologies enabling lateral flow testing for gastrointestinal pathogens using stool samples.
Campylobacter is a Gram-negative bacteria that is the most common bacterial cause of diarrheal illness in the US, according to the US Centers for Disease Control and Prevention. The CDC estimates that 1.5 million people each year are infected via contaminated food, particularly undercooked poultry. The agency has previously also encouraged labs employing culture-independent diagnostic tests to also perform reflex culture for public health reporting purposes.