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Biomerica Achieves IVDR Certification in the European Union for Food Intolerance Tests Targeting Crohn’s Disease and Ulcerative Colitis
A new CE-marked food-intolerance diagnostic could give people with Crohn’s or UC a non-invasive tool to explore dietary triggers alongside clinical care. Regulatory certification means the products met EU safety and performance rules, which may increase availability in Europe.
Patients with Crohn’s disease or ulcerative colitis interested in diet-based testing, clinicians who manage IBD, and patient advocates following diagnostic test availability and regulatory clearances.
What To Know
Biomerica announced EU IVDR (CE-marking) certification for its food intolerance diagnostic products aimed at people with Crohn’s disease and ulcerative colitis. The company says the tests use proprietary technology to identify foods that may trigger inflammation and plans near-term product launch/market expansion in Europe.
This is a company press release about regulatory certification (IVDR/CE mark) and planned commercial launch. The announcement does not provide independent clinical data in the text, nor details on diagnostic accuracy, how results should be used clinically, or guideline endorsement. People should discuss any test results with their care team before changing treatment or diet.
