Meridian Bioscience Continues Expansion of H. pylori Diagnostic Testing Solutions with FDA Clearance of Premier HpSA Flex
26 July 2023
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 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.
