At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. We are excited and proud to announce 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. Receiving the IVDR-CE mark means the assay meets the rigorous IVDR standards set by the European Union, ensuring it is safe, effective, and ready for widespread clinical use in geographies accepting the CE mark certification. AliveDx is expanding its impact across CE mark accepting geographies, helping to improve the lives of those affected by celiac disease.
Simplified workflow, fast results, actionable insights
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. By including the most clinically relevant autoantibodies, i.e. 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.
