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Mobidiag Lands CE-IVD Mark for Gastric Pathogen Detection and Drug Resistance Test

NEW YORK (GenomeWeb) – Finnish molecular diagnostics firm Mobidiag today announced that its Amplidiag qPCR-based stool test for detection of Helicobacter pylori and clarithromycin resistance has received CE-IVD marking.

The test, part of the firm's Amplidiag line of gastric pathogen tests, will be immediately available throughout Europe.

H. pylori is a gastric pathogen that may cause dyspepsia, gastro-esophageal reflux disease, peptic ulcers, and gastric cancer. Current tests for the pathogen do not provide information on antibiotic resistance to first-line therapies like clarithromycin. If first-line therapies fail, a biopsy is often needed to determine antibiotic susceptibility.

The Amplidiag H. pylori+ClariR test can guide doctors in selecting an effective primary antibiotic and thereby reduce the number of gastric biopsies, Mobidiag CEO Tuomas Tenkanen said in a statement. "Through systematic use, the test can help reduce the overall healthcare costs related to the diagnostics, treatment, and complications of H. pylori infection."

In April, the firm's Amplidiag test for Clostridium difficile received CE marking.