Switzerland's AliveDx receives IVDR-CE mark for multiplexed assay detecting celiac disease

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Switzerland-based AliveDx has received IVDR-CE mark certification for its multiplexed MosaiQ AiPlex CD microarray immunoassay, designed to improve the accuracy and speed of diagnosing celiac disease. The newly IVDR-CE marked MosaiQ AiPlex CD microarray immunoassay offers healthcare providers with a novel, unique solution to help shorten the diagnostic delay and reduce the unnecessary burden of celiac disease testing.

Diagnosis of celiac disease typically involves serological testing for specific autoantibodies, with other clinical, laboratory, imaging, genetic, and histopathological findings. By including the most clinically relevant autoantibodies, including tTG IgA, DGP IgA, tTG IgG and DGP IgG as well as the detection of total IgA antibodies, it is designed to provide more complete diagnostic insights with a single sample and blood draw and to help laboratories automate and streamline the celiac disease diagnostic pathway. Once diagnosed with celiac disease, patients can benefit quickly from Gluten-Free Diet (GFD) to reduce gastrointestinal symptoms as well as to prevent long term, potentially severe health implications.

The MosaiQ AiPlex CD approval enhances our current autoimmune turnkey solution of MosaiQ, MosaiQ AiPlex CTD, and LumiQ portfolio. Additionally, AliveDx expects to significantly grow the menu of its MosaiQ autoimmune and allergy portfolio in 2025 and beyond.