AliveDx 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.
A global challenge
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.
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.
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.
“We are thrilled to obtain the CE mark for our MosaiQ AiPlex CD microarray,” said Manuel O. Mendez, CEO of AliveDx. “The MosaiQ fast portfolio expansion marks our fourth microarray CE mark approval in the last 12 months reflecting our dedication to rapidly advance diagnostic technologies and our commitment to support the millions of individuals affected by autoimmune diseases. Early and accurate diagnosis is crucial for managing this condition. Our innovative MosaiQ microarray solutions represent a significant advancement to partner with laboratorians and clinicians to reduce healthcare costs and improve patient outcomes and quality of life.”
About MosaiQ platform
A fully automated high-throughput platform that streamlines multiplex testing for Autoimmune, Allergy, and beyond. This intuitive platform delivers fast and accurate results using advanced microarray panels to rapidly detect and identify disease markers in up to 425 results per hour. With an expanding portfolio of tests, it continues to maximize workflow efficiencies, simplify pathways, and help shorten time to diagnosis.
*1 Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76.
