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Commonwealth gains license to market IBS, SIBO tests in Canada
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Heath Canada granted a medical device establishment license to Commonwealth Diagnostics International for their noninvasive tests for irritable bowel syndrome and other functional GI disorders like small intestine bacterial overgrowth and carbohydrate malabsorption disorders, the company announced.
The Hydrogen and Methane Breath Test for SIBO works by measuring how much hydrogen and methane a patient produces after ingesting a carbohydrate substrate solution, according to the company’s website. If the test measures at least 100,000 bacteria per mL of fluid, the patient could have small intestine bacterial overgrowth (SIBO), according to a press release issued by the company.
The company’s breath tests for carbohydrate malabsorption and its ELISA blood test for irritable bowel syndrome called IBSchek will also become available for use in Canada, per the press release.
“CDI’s entry into Canada improves the options available to both patients who are suffering from gastrointestinal disorders and health care providers challenged with diagnosing, managing, and treating the patients’ conditions,” according to the press release. “CDI’s easy-to-use diagnostic products can be used by patients in the comfort of their own home and results are delivered 24 hours after specimens are received at its CLIA-certified laboratory for analysis.”
Reference: http://www.commdx.com/small-intestinal-bacterial-overgrowth.html