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Meridian Bioscience Gets FDA OK for H. Pylori Immunoassay

NEW YORK – Meridian Bioscience said on Tuesday that it has received US Food and Drug Administration clearance for its Premier HpSA Flex assay for the diagnosis of Helicobacter pylori in both preserved and unpreserved stools.

Premier HpSA Flex is an enzyme immunoassay used to qualitatively detect H. pylori-specific antigens in fresh, frozen, or preserved human fecal specimens. It joins other Meridian H. pylori products including the BreathID urea breath test for H. pylori, Curian HpSA fluorescent immunoanalyzer antigen test, and ImmunoCard Stat! HpSA rapid colorimetric antigen test.

H. pylori infection is linked to several significant upper gastrointestinal conditions including chronic gastritis, peptic ulcer disease, and gastric cancer.

"Meridian is committed to developing the industry's broadest range of highly accurate gastrointestinal diagnostic solutions enabling clinicians to use the sample types and testing platforms required in today's ever-evolving healthcare landscape," Tony Serafini-Lamanna, president of Meridian Bioscience Diagnostics, said in a statement.