AliveDx plans to expand its MosaiQ autoimmune and allergy test menu. Credit: warut pothikit / Shutterstock.

AliveDx has obtained European In Vitro Diagnostic Device Regulation (IVDR) CE mark certification for its MosaiQ AiPlex CD microarray immunoassay, designed to accurately and swiftly diagnose celiac disease.

The certification signifies that the assay complies with the stringent IVDR standards mandated by the European Union, confirming its safety and efficacy for clinical use within CE mark-accepting regions.

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The MosaiQ AiPlex CD assay operates on the MosaiQ platform and offers a new approach to celiac disease testing by incorporating the most clinically relevant autoantibodies.

This comprehensive testing method aims to provide more complete diagnostic insights from a single blood sample.

AliveDx’s expansion into CE mark-accepting geographies with the IVDR-CE marked MosaiQ AiPlex CD assay is poised to improve the lives of individuals affected by celiac disease.

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The assay allows patients to benefit from a gluten-free diet (GFD) to alleviate gastrointestinal symptoms and prevent long-term health complications.

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The company’s MosaiQ platform, a fully automated high-throughput system, is designed to deliver fast and accurate results. The platform’s advanced microarray panels can detect and identify disease markers, processing up to 425 results per hour.

With the addition of the MosaiQ AiPlex CD assay, AliveDx enhances its current autoimmune solution portfolio, which includes MosaiQ, MosaiQ AiPlex CTD, and LumiQ.

AliveDx plans to expand its MosaiQ autoimmune and allergy test portfolio starting next year and beyond.

AliveDx CEO Manuel O Mendez said: “The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition.

“Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life.”

In July 2024, AliveDx secured an IVDR CE mark for its microarray immunoassay in allergy diagnostics.