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Revolutionary Celiac Disease Diagnosis: AliveDx Announces FDA Application!
AliveDx submits an application to the FDA for an innovative microarray for celiac disease diagnosis that increases efficiency.
Revolutionary Celiac Disease Diagnosis: AliveDx Announces FDA Application!
Austria's healthcare system receives a significant technological advance as AliveDx announced that it has submitted an application for a 510(k) premarket notification for the new MosaiQ AiPlex® celiac disease microarray to the U.S. Food and Drug Administration (FDA) submitted. This cutting-edge diagnostic tool aims to significantly speed up and simplify the procedures for identifying celiac disease. The development of this multiplex test, which received IVDR-CE certification in August 2024, aims to provide early diagnosis of this chronic autoimmune disease that affects millions of people worldwide. The MosaiQ AiPlex CD assay makes it possible to obtain results with only 20 μL of a patient sample in a single step, significantly increasing efficiency in clinical practice, such as ots.at reported.
Automated solutions for diagnosing autoimmune diseases
In addition to the advancements in celiac disease, AliveDx has also received IVDR CE clearance for the MosaiQ AiPlex® CTDplus multiplex assay for systemic autoimmune diseases. These tests facilitate the precise diagnosis of diseases such as rheumatoid arthritis and systemic lupus erythematosus, providing important support for physicians and laboratory staff. Microwave technology enables simultaneous detection of up to 15 relevant autoantibodies and provides estimated results from only 10 μL of patient sample, significantly speeding up the process of diagnosis, such as adnkronos.com highlights.
MosaiQ solutions are not only designed for speed and accuracy, but also provide simplified workflow navigation for laboratories and clinics. The combination-based approach makes it possible to obtain relevant diagnostic information in just one test run, while reducing the need for extensive resources, which is crucial in future-oriented healthcare services. This innovative design reflects AliveDx's commitment to advancing diagnostic technologies and addressing autoimmune disease challenges globally.