CE-IVD Mark Received for Simultaneous Helicobacter Pylori and Antibiotic Resistance Test

The unique test is a first-available, noninvasive molecular assay for reliable, stool sample detection of the gastric pathogen Helicobacter pylori as well as of clarithromycin resistance, one of H. pylori’s key resistances.

H. pylori has been estimated to colonize half the world’s population and a 2014 report by the International Agency for Research on Cancer (IARC of the World Health Organization (WHO)) recommends population-wide screening for prevention.

The test “Amplidiag H. pylori+ClariR” from Mobidiag Ltd. (Espoo, Finland) is immediately available throughout Europe, expands the gastrointestinal Amplidiag menu, and contributes to the global fight against gastric cancers. The test is a rapid, qualitative qPCR-based assay performed directly from stool DNA extract, and aims at primary testing in cases where H. pylori infection is suspected. It is cost-effective especially for high-volume screening in mid-sized to large laboratory settings.

Through its unique ability to detect a key antibiotic resistance in conjunction with the pathogen, the test enables targeting of primary eradication therapy without invasive procedures and additional waiting. The current primary diagnostic tests (including stool antigen tests, urea breath tests, and serological tests) are incapable of detecting antibiotic resistances. There is strong evidence that eradication reduces the risk of developing gastric cancer. Clarithromycin is a key part of first-line eradication therapy, and resistance to clarithromycin is the leading cause of therapy failures. Especially in cases of therapy failure, secondary diagnostics relies on gastric biopsy and subsequent pathogen culturing and antibiotic susceptibility testing—an invasive methodology that is time consuming, inconvenient, and expensive.

Performance of Amplidiag H. pylori+ClariR was evaluated with nearly 300 clinical samples and compared to two commonly used stool antigen tests. Positive samples were then sequenced to verify the result and correct identification of clarithromycin resistance gene mutations. The established sensitivity and specificity for H. pylori identification were 93.1% and 99.2%, respectively, while both were 100% for clarithromycin resistance mutation detection. Out of the nearly 300 samples, the test identified 54 true positive samples, of which 12 were found to have a clarithromycin resistance mutation.

“We are very excited in bringing this novel noninvasive test to the market and believe it will be a major contribution in diagnostic and treatment processes for this common pathogen,” said Tuomas Tenkanen, CEO, Mobidiag. “It should guide antibiotics selection in primary eradication therapy, result in increased therapy success rates, and thereby reduce the number of gastric biopsies in low-risk patients. Through systematic use, the test can help reduce the overall healthcare costs related to the diagnostics, treatment, and complications of H. pylori infection.”

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Amplidiag H. pylori+ClariR test