Meridian Bioscience Receives FDA Clearance for Premier HpSA Flex, Expanding H. pylori Diagnostic Testing Solutions

Wednesday, July 26, 2023

Meridian Bioscience, a global leader in diagnostic testing solutions and life science raw materials, has received FDA clearance for their Premier HpSA FLEX, a diagnostic test for Helicobacter pylori (H. pylori) in both preserved and unpreserved stools. This new addition joins Meridian's extensive portfolio of H. pylori products, including BreathID (urea breath test), Curian HpSA (fluorescent immuno analyzer antigen test), and ImmunoCard Stat! HpSA (rapid colorimetric antigen test).

The Premier HpSA FLEX test is a non-invasive enzyme immunoassay that enables clinicians to detect H. pylori-specific antigens in fresh, frozen, or preserved human fecal specimens. H. pylori infection is associated with various upper gastrointestinal conditions, such as chronic gastritis, peptic ulcer disease, and gastric cancer.

Tony Serafini-Lamanna, President of Meridian Bioscience Diagnostics, emphasized their commitment to developing highly accurate gastrointestinal diagnostic solutions to meet the evolving needs of healthcare professionals. H. pylori is present in the stomach lining of approximately 1 in 3 people and, if left untreated, can lead to gastric cancer. However, once diagnosed, H. pylori infection can be easily treated with antibiotics. Hence, the company's focus on non-invasive and patient-friendly testing methods aims to help clinicians promptly and safely diagnose and treat patients.

For those interested in learning more about Meridian's diagnostic testing solutions, they can visit their exhibit booth (4039) during the AACC conference held in July in Anaheim, California.


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