Biomerica has received CE-marking for its food intolerance tests tailored for ulcerative colitis (UC) and Crohn’s disease, under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).
With the IVDR certification, the company can now pursue market expansion within the European in vitro diagnostic market.
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The certification may also facilitate access to international markets, in line with the company’s global growth strategy.
The CE-marking signifies a crucial step for Biomerica, showcasing the company’s compliance with the EU’s stringent IVDR requirements.
These new regulations aim to improve the quality, performance, and safety of in-vitro diagnostics within Europe.
Biomerica CEO Zack Irani said: “Achieving IVDR certification is a testament to our dedication to creating diagnostic products that achieve the highest technical standards.
“This certification not only validates the safety and effectiveness of our products but also positions Biomerica to expand sales of these products in the European market. Our teams are now finalising the materials for product launch in the near future.”
Biomerica noted that its tests met the General Safety and Performance Requirements, paving the way for providing solutions to enhance patient outcomes.
The food intolerance products offer a “personalised” and “non-invasive” therapy option for individuals suffering from these conditions.
The technology behind these tests detects certain dietary triggers that may cause inflammation in patients with UC and Crohn’s, offering a new approach to symptom management and quality of life improvement.
Biomerica mainly concentrates on gastrointestinal and inflammatory conditions, with several products in development.
Last month, the company secured approval from the UAE Ministry of Health and Prevention for its Fortel prostate-specific antigen screening test, which aids in the early detection of prostate cancer.
