Mobidiag Ltd has announced the CE-IVD marking of Amplidiag™ H. pylori+ClariR. The qualitative qPCR-based test expands the gastrointestinal Amplidiag test menu and is immediately available throughout Europe.
The first-to-market, non-invasive molecular diagnostic test reliably detects the gastric pathogen H. pylori as well as one of its key resistances to clarithromycin. The test is performed directly from stool DNA extract in a rapid manner.
Amplidiag H. pylori+ClariR is aimed at primary testing in cases where H. pylori infection is suspected. Through the unique ability to detect a key antibiotic resistance in conjunction with the pathogen, the test enables the targeting of primary eradication therapy without inconvenient invasive procedures and unnecessary waiting. In the longer term, the test is expected to contribute to the fight against gastric cancers, a global killer consistently associated with H. pylori infection.
The test performance was evaluated with nearly 300 clinical samples and was compared to two commonly used stool antigen tests. All positive findings were further sequenced to verify the result and the correct identification of the clarithromycin resistance gene mutations.
The established sensitivity and specificity for H. pylori identification were 93.1% and 99.2%, respectively, while both figures were 100% for clarithromycin resistance mutation detection. Out of the nearly 300 samples, Amplidiag H. pylori+ClariR identified 54 true positive samples, of which 12 were found to have a clarithromycin resistance mutation.
Helicobacter pylori a common gastric pathogen associated with gastric cancer
H. pylori is a gastric pathogen which has been estimated to colonize half the world’s population, and may cause dyspepsia, gastro-esophageal reflux disease, peptic ulcers and gastric cancer. According to a recent report by the International Agency for Research on Cancer (IARC), a specialized cancer agency of the World Health Organization, there are about one million new cases of gastric cancer and over 700,000 related deaths each year. The report also recommends population-wide screening of H. pylori to prevent gastric cancer.
The current primary diagnostic tests include stool antigen tests, urea breath tests and serological tests. These methods, while popular and well established, are incapable of detecting antibiotic resistances. Especially in cases of therapy failure, secondary diagnostics relies on gastric biopsy and subsequent pathogen culturing and antibiotic susceptibility testing - an invasive methodology which is time consuming, inconvenient and expensive.
Clarithromycin is a key part of first-line eradication therapy, and resistance to clarithromycin is the leading cause of therapy failures. According to the Maastricht IV/ Florence Consensus Report, the success rate of the eradication therapy is only 10-30% in the case of clarithromycin-resistant H. pylori; and in cases of first-line treatment failure, the chance of having a clarithromycin-resistant strain is 60-70%. Further, the report states that there is strong evidence that eradication reduces the risk of developing gastric cancer.
“We are very excited in bringing this novel non-invasive test to the market and believe it will be a major contribution in diagnostic and treatment processes for this common pathogen”, says Tuomas Tenkanen, CEO of 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.”