AliveDx has received IVDR-CE mark certification from the EU for its MosaiQ AiPlex CD microarray immunoassay, which is designed to enhance the speed and accuracy of diagnosing celiac disease.
The assay is built to detect the most clinically relevant autoantibodies associated with celiac disease and help laboratories automate the diagnostic pathway. It is claimed to provide diagnostic insights from a single sample and blood draw.
AliveDx is an in vitro diagnostics company that specializes in developing disease detection and diagnosis. The company's product portfolio includes Alba, a transfusion portfolio, and MosaiQ, an automated multiplexing and multimodality clinical diagnostics solution, which is a fully automated high-throughput platform that streamlines multiplex testing for autoimmune diseases, allergies, and other conditions. MosaiQ combines a user-friendly instrument platform, proprietary planar multiplex microarray technology, and an intelligent image analysis algorithm to enable faster turnaround times for complex diagnostic pathways.
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