2024-09-03 17:44:02
AliveDx is dedicated to driving diagnostic insights, improved patient care and lifelong innovation. We are pleased and proud to announce that AliveDx’s MosaiQ AiPlex™ multiplex CD microarray immunoassay has received IVDR CE certification, which is designed to improve the accuracy and speed of celiac disease diagnosis. Obtaining the IVDR CE mark means that this detection method complies with the EU’s strict IVDR standards, so it is safe, effective, and can be widely used clinically in countries that recognize the CE mark. AliveDx is expanding its presence in all countries that accept the CE mark to help improve the lives of people with celiac disease.
global challenges
Celiac disease is a chronic autoimmune disease with a global prevalence of 1 in 1,000 people that primarily affects the small intestine and is often associated with a variety of clinical multi-organ symptoms. The abnormal immune system response in celiac disease is triggered by gluten ingestion in genetically susceptible individuals and leads to the formation of autoantibodies and damage to the small intestine.
Diagnosis of celiac disease usually includes serologic testing for specific autoantibodies and other clinical, laboratory, imaging, genetic, and histopathological findings. Clinical guidelines recommend testing for IgA autoantibodies to tissue transglutaminase (anti-tTG-IgA) and deamidated gliadin peptide (anti-DGP-IgA).
Because some people with celiac disease may have selective IgA deficiency, it is recommended to measure total IgA levels in addition to autoantibodies. If IgA is deficient, testing for relevant IgG autoantibodies (eg, anti-tTG IgG, anti-DPG IgG) is recommended. Users must consult current guidance for further details.
Streamlined workflows, fast results, actionable insights
The MosaiQ AiPlex CD microarray immunoassay recently received the IVDR-CE mark, providing healthcare providers with a novel and unique solution to shorten diagnosis time and reduce the unnecessary burden of celiac disease testing. By including tests for the most clinically relevant autoantibodies, namely tTG IgA, DGP IgA, tTG IgG and DGP IgG, as well as total IgA antibodies, it is designed to provide more comprehensive diagnostic insights from a single sample and blood draw to help laboratories Identify celiac disease and simplify diagnosis. 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 approval of MosaiQ AiPlex CD expands our current portfolio of turnkey autoimmune solutions, including MosaiQ, MosaiQ AiPlex CTD and LumiQ. Additionally, AliveDx expects to significantly expand the menu of its MosaiQ autoimmune and allergy product portfolio by 2025 and beyond.
“We are pleased to receive CE Mark approval for our MosaiQ AiPlex CD microarrays,” said Manuel O. Mendez, CEO of AliveDx. “The rapid expansion of our MosaiQ product portfolio marks the fourth CE mark approval for our microarrays in the past 12 months. The approval reflects significant progress in our commitment to physician collaboration to reduce healthcare costs and improve patient outcomes and quality of life.
Information about the MosaiQ platform
A fully automated, high-throughput platform that simplifies multiplex testing for autoimmune diseases, allergies and more. This intuitive platform offers Fast and accurate results use Advanced microarray plates For rapid detection and identification of disease markers, producing up to 425 results per hour. Workflow efficiencies are maximized as test portfolios continue to grow, workflows are streamlined and diagnostic time is reduced.
For more information about AliveDx and its diagnostic solutions, please visit Alivedx.com
Information about AliveDx
AliveDx is dedicated to unlocking diagnostic insights, improving patient care and lifelong innovation. With over 30 years of in vitro diagnostics experience, we want to drive 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 product portfolio includes the Alba, MosaiQ® and LumiQ™ brands. 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 provide customers with differentiated, turnkey, end-to-end autoimmune diagnostic solutions. Our brands are designed to create commercial and clinical value. We accomplish this by streamlining 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 Swiss Company. 2024. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex are trademarks or registered trademarks of the AliveDx Group of Companies in various countries. Menus and options are subject to change. Not all methods are suitable for all areas. Subject to regulatory approval.
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