Meridian Bioscience, Inc. announced 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 samples. Meridian's Premier HpSA FLE X test is a non-invasive enzyme immunoassay used to clinically detect Helicobacter pylori (H. pylori) specific antigens in fresh, frozen, or preserved human tissue specimens.

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