AliveDx is dedicated to advancing diagnostic insights, improving patient care and innovating for life. We are pleased and proud to announce that AliveDx has received IVDR CE certification for its MosaiQ AiPlex™ multiplex CD microarray immunoassay, designed to improve the accuracy and speed of celiac disease diagnosis. Obtaining the IVDR CE mark means that the assay meets the European Union’s rigorous IVDR standards and is therefore safe, effective and ready for widespread clinical use in countries that recognize the CE mark. AliveDx is expanding its impact in all countries that accept the CE mark, helping to improve the lives of those affected by celiac disease.
A global challenge
Celiac disease is a chronic autoimmune disease with a worldwide prevalence of 1 in 1001, primarily affecting the small intestine and often associated with a variety of clinical multi-organ symptoms. The abnormal immune system response in celiac disease is triggered by consumption of gluten in genetically susceptible individuals and leads to the formation of autoantibodies and damage to the small intestine.
The diagnosis of celiac disease usually includes a serological test for specific autoantibodies as well as other clinical, laboratory, imaging, genetic and histopathological findings. Clinical guidelines recommend testing for IgA autoantibodies against tissue transglutaminase (anti-tTG-IgA) and deamidated gliadin peptides (anti-DGP-IgA).
Since some people with celiac disease may have selective IgA deficiency, it is advisable to measure total IgA levels in addition to autoantibodies. In the case of IgA deficiency, a test for relevant IgG autoantibodies (e.g. anti-tTG IgG, anti-DPG IgG) is recommended. It is important that users consult current guidance for further details.
Simplified workflow, fast results, actionable insights
Recently awarded the IVDR-CE mark, the MosaiQ AiPlex CD microarray immunoassay offers healthcare providers a novel, unique solution to shorten diagnosis time 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 intended to provide more comprehensive diagnostic insights with a single sample and blood draw, helping laboratories to identify celiac disease. Automate and streamline diagnostics. Once diagnosed with celiac disease, patients can quickly benefit from a gluten-free diet (GFD) to relieve gastrointestinal symptoms and prevent long-term, potentially serious health consequences.
The MosaiQ AiPlex CD approval expands our current portfolio of turnkey autoimmune solutions, consisting of MosaiQ, MosaiQ AiPlex CTD and LumiQ. Additionally, AliveDx expects to significantly expand the menu of its MosaiQ autoimmune and allergy portfolio through 2025 and beyond.
“We are thrilled to have received CE Mark approval for our MosaiQ AiPlex CD Microarray,” said Manuel O. Mendez, CEO of AliveDx. “MosaiQ’s rapid portfolio expansion marks our fourth CE approval for microarrays in the last 12 months and reflects our commitment to the rapid advancement of diagnostic technologies and our commitment to supporting the millions of people affected by autoimmune diseases. Our innovative MosaiQ microarray solutions provide a represents significant progress in collaborating with laboratory and clinical physicians to reduce healthcare costs and improve patient outcomes and quality of life.”
Information about the MosaiQ platform
A fully automated, high-throughput platform that streamlines multiplex testing for autoimmune diseases, allergies and beyond. This intuitive platform delivers fast and accurate results using advanced microarray panels for rapid detection and identification of disease markers with up to 425 results per hour. With a growing portfolio of tests, workflow efficiency is maximized, workflows are simplified and time to diagnosis is reduced.
For more information about AliveDx and its diagnostic solutions, visit Alivedx.com
Information about AliveDx
AliveDx is dedicated to unlocking diagnostic insights, improving patient care and innovating for life. With over 30 years of experience in in vitro diagnostics, we want to advance the future of diagnostics worldwide. We put patient health first and develop innovative solutions that enable laboratories and clinicians to reduce time to diagnosis. Our portfolio includes the brands Alba, MosaiQ® and LumiQ™. Alba is our range of reagents for blood banks and hospitals. MosaiQ is our automated, flexible, high-throughput, continuous random access microarray solution for clinical laboratories. LumiQ is our innovative, automated solution for immunofluorescence testing (IFA). Together, they can offer customers a differentiated, turnkey, end-to-end solution for autoimmune diagnostics. Our brands aim to create both commercial and clinical value. We achieve this by simplifying laboratory workflows and delivering fast, accurate results that simplify clinical decision making. At AliveDx we innovate for life.
*1 Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76.
©AliveDx Suisse SA. 2024. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex are trademarks or registered trademarks of the AliveDx group companies in various countries. Menus and options are subject to change. Not all methods may be available in all areas. Subject to regulatory approval.
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