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Meridian Bioscience Submits Platform, HpSA Assay for FDA Approval

NEW YORK – Meridian Bioscience said on Wednesday that it has submitted its Curian analyzer and Curian HpSA assay for H. pylori infection diagnosis to the US Food and Drug Administration for review.

The platform and assay use fluorescent lateral flow technology to detect Helicobacter pylori antigens in human stool, and the assay is also intended to monitor patients' responses during and after therapy.

H. pylori is considered the leading cause for chronic gastritis and can also cause gastric cancer, the Cincinnati, Ohio-based company said.

"We are excited to be the first to develop a rapid fluorescent lateral flow HpSA assay," said Lawrence Mertz, the company's senior VP of research and development, in a statement. "The use of fluorescent technology coupled with an automated analyzer readout provides a result that can be read without the risk of subjective analysis by the technician."