AliveDx Receives IVDR-CE Mark for Multiplexed Assay to Accurately Detect Celiac Disease (CD) on the MosaiQ® System

EYSINS, Switzerland, Sept. 3, 2024 /PRNewswire/ -- 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

Celiac disease is a chronic autoimmune disorder with a global prevalence of 1 in 100[1], primarily affecting the small intestine, often accompanied by a variety of multiorgan clinical symptoms. The immune system’s abnormal response in celiac disease is triggered by the consumption of gluten in genetically susceptible individuals, leading to the production of autoantibodies and small bowel damage.

Diagnosis of celiac disease typically involves serological testing for specific autoantibodies, with other clinical, laboratory, imaging, genetic, and histopathological findings. For instance, clinical guidelines recommend testing for IgA autoantibodies against tissue Transglutaminase (anti-tTG IgA) and Deamidated Gliadin Peptides (anti-DGP IgA).

Given that some individuals with celiac disease may have selective IgA deficiency, it is advised to measure total IgA levels alongside autoantibodies. In cases of IgA deficiency, testing for relevant IgG autoantibodies (e.g., anti-tTG IgG, anti-DPG IgG) is recommended. It is important for users to consult current guidelines for further details

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