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Meridian Bioscience gets CLIA waiver status for stomach ulcer test
By Elaine Rigoli
Tampa, Fla., June 12 - Meridian Bioscience, Inc. has received CLIA waiver status from the Food and Drug Administration for its ImmunoCard STAT! HpSA test, a rapid, single-use test for the diagnosis of Helicobacter pylori (H. pylori) infection.
Meridian said the vast majority of peptic ulcer disease is caused by infection with H. pylori bacteria and, in recent years, effective therapies have become available for eradicating this disease.
Peptic ulcer disease impacts millions of Americans resulting in more than $6 billion in health care costs each year, according to a news release.
CLIA waiver status means that now doctors' offices can employ "test and treat" medicine designed to eradicate infection while reducing future risk significantly and reducing health care costs.
Cincinnati-based Meridian is a fully integrated life science company.
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