Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) has cleared Premier® HpSA® FLEX™ for the diagnosis of H. pylori in both preserved and unpreserved stools.
| CINCINNATI, July 25, 2023 /PRNewswire/ -- Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) has cleared Premier® HpSA® FLEX™ for the diagnosis of H. pylori in both preserved and unpreserved stools. Premier HpSA Flex joins the extensive Meridian H. pylori portfolio of products that includes BreathID® (urea breath test for H. pylori), Curian® HpSA (fluorescent immuno analyzer antigen test), and ImmunoCard® Stat! HpSA (rapid colorimetric antigen test).
Meridian is committed to developing the broadest range of highly accurate gastrointestinal diagnostic solutions. Meridian strives to continuously improve existing products. The Premier HpSA FLEX workflow improvement recently cleared by FDA allows clinicians to use preserved stools in Cary-Blair and C&S in addition to fresh or frozen unpreserved samples. Meridian’s Premier HpSA FLEX test is a non-invasive enzyme immunoassay used to qualitatively detect Helicobacter pylori (H. pylori) specific antigens in fresh, frozen, or preserved human fecal specimens. Helicobacter pylori infection is linked to several significant upper gastrointestinal (GI) 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,” stated Tony Serafini-Lamanna, President of Meridian Bioscience Diagnostics. “H. pylori is found in the stomach lining of 1 in 3 people1 and, if left untreated, can lead to gastric cancer. However, once diagnosed, an H. pylori infection can be easily treated with antibiotics. That is why we continue to develop highly accurate non-invasive, patient-friendly H. pylori testing methods to help clinicians get patients on the road to wellness as fast and safely as possible.” You can learn more about Meridian’s diagnostic testing solutions by visiting their exhibit booth (4039) during this year’s AACC conference held in July in Anaheim, California. You can schedule a one-on-one meeting with a Meridian representative by emailing sales@meridianbioscience.com. To learn more about H. pylori and Meridian’s testing solutions, please visit www.meridianbioscience.com/hpylori. 1. Fennerty, M. B. Helicobacter pylori: why it still matters in 2005. Cleveland Clinic Journal of Medicine, 2005; 72(Suppl_2), S1-7. https://doi.org/10.3949/ccjm.72.suppl_2.s1. About Meridian Bioscience, Inc. Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic and life science products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world. Meridian is a privately held company headquartered in Cincinnati, Ohio. Meridian’s website address is www.meridianbioscience.com. Contact: Courtney Schulz
SOURCE Meridian Bioscience, Inc. |
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