Meridian Bioscience gets FDA OK to market stomach ulcer test

By Angela McDaniels

Seattle, March 16 - Meridian Bioscience Inc. has received clearance from the Food and Drug Administration to market its Premier Platinum HpSA Plus test for the diagnosis of Helicobacter pylori infection, according to a company news release.

The company said the vast majority of peptic ulcer disease is caused by Helicobacter pylori infection and, in recent years, effective therapies have become available for treating such an infection.

"Recently, the American Gastroenterological Association issued important guidelines that support the use of direct Helicobacter pylori tests prior to prescribing symptom-relieving drugs," president and chief operating officer John Kraeutler said in the release.

"[Additionally], Premier Platinum HpSA Plus offers improved accuracy and ease of use that make the test ideally suited for higher-volume labs."

Health care costs relating to peptic ulcer disease reach more than $6 billion in the United States each year, according to the company, and roughly 30% of the U.S. population is infected with Helicobacter pylori.

Meridian Bioscience is a life science company based in Cincinnati that manufactures, markets and distributes diagnostic test kits and purified reagents.

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