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Meridian Bioscience Nabs FDA Clearance for Shiga Toxin Assay

NEW YORK – Meridian Bioscience said Wednesday that it gained US Food and Drug Administration 510(k) clearance for the firm's Curian Shiga Toxin immunoassay, expanding the firm's gastrointestinal disease product line.

The qualitative fluorescent immunoassay is used for the detection and differentiation of Shiga toxins 1 and 2 in stool samples to aid diagnosis of gastrointestinal disease caused by infections with Shiga toxin-producing Escherichia coli, including non-O157 strains. The test is designed for use on the firm's Curian analyzer.

Meridian Bio, part of SD Biosensor, said that when the assay was performed on prospective samples, it provided 100 percent sensitivity and greater than 99 percent specificity for both toxins. The company said the Curian Shiga Toxin test also has a lower limit of detection than conventional rapid immunoassays, and the test system provides objective results instead of the more subjective visual interpretation of lateral flow assay results.

The firm also sells the Curian HpSA assay that targets Helicobacter pylori and the Curian Campy assay for detection of Campylobacter species C. jejuni, C. coli, C. upsaliensis, and C. lari. Tony Serafini-Lamanna, president of Meridian Bioscience Diagnostics, said in a statement that Curian now has the broadest menu of gastrointestinal tests on an immunoassay analyzer.

"Curian Shiga Toxin has a market-leading three-step sample prep workflow and produces fast, objective results that can help laboratorians and clinicians provide an objective Shiga toxin diagnosis and get patients on the correct treatment and back on the road to wellness."