AliveDx Celebrates IVDR-CE Mark for Celiac Disease Detection
We at AliveDx are excited to share a major milestone in our quest to transform diagnostics. Our cutting-edge MosaiQ AiPlex™ CD microarray immunoassay has successfully received the IVDR-CE mark certification. This achievement highlights its safety and effectiveness in accurately diagnosing celiac disease. By adhering to the rigorous IVDR standards established by the European Union, this certification opens doors for broader clinical application in various regions that recognize the CE mark. This progress not only promotes better patient care but also significantly improves the lives of those living with celiac disease.
Celiac Disease: A Common Health Concern
Celiac disease is a chronic autoimmune disorder that impacts around 1 in 100 people worldwide. It presents numerous health challenges, often resulting in a range of symptoms affecting multiple organs. This condition arises from an abnormal immune response to gluten in individuals who are genetically predisposed, potentially causing intestinal damage and various complications. Therefore, obtaining an accurate and timely diagnosis is crucial for effective management and improved patient outcomes.
Challenges in Diagnosis and Testing Protocols
Healthcare professionals typically use serological testing for specific autoantibodies to diagnose celiac disease. The standard approach involves testing for IgA autoantibodies against tissue Transglutaminase (anti-tTG IgA) and Deamidated Gliadin Peptides (anti-DGP IgA). Since some individuals may have selective IgA deficiency, it is essential to assess total IgA levels as well, which can enhance diagnostic accuracy. If IgA levels are low, testing for IgG autoantibodies like anti-tTG IgG is recommended.
Efficient Workflow and Quick Results
The newly certified MosaiQ AiPlex CD microarray immunoassay is a revolutionary tool that empowers healthcare practitioners to speed up the diagnostic process for celiac disease. It allows for the simultaneous testing of key autoantibodies, including tTG IgA, DGP IgA, tTG IgG, and DGP IgG, all from a single blood sample. This not only improves diagnostic insights but also enables laboratories to optimize their operations, significantly shortening the wait time for patients. Early diagnosis can facilitate timely intervention through a Gluten-Free Diet (GFD), relieving gastrointestinal symptoms and preventing serious health complications in the long run.
A Holistic Autoimmune Diagnostic Solution
The approval of MosaiQ AiPlex CD enhances our existing range of autoimmune diagnostic tools, which includes the MosaiQ and LumiQ portfolios. As we look ahead to 2025 and beyond, AliveDx is dedicated to further expanding our diagnostic capabilities, providing an even wider array of options within the MosaiQ autoimmune and allergy diagnostics.
A Message from Our CEO
“We are incredibly excited to receive the CE mark for our MosaiQ AiPlex CD microarray,” expressed Manuel O. Mendez, CEO of AliveDx. “This accomplishment reflects our unwavering commitment to advancing diagnostic technologies and underscores our dedication to supporting the millions affected by autoimmune diseases. An early and accurate diagnosis is essential for effective management of this condition. Our innovative MosaiQ microarray solutions represent a significant step forward in improving patient outcomes, reducing healthcare costs, and enhancing the quality of life for those we serve.”
About the MosaiQ Platform
The MosaiQ platform is a fully automated, high-throughput diagnostic solution designed to facilitate multiplex testing for autoimmune disorders, allergies, and more. This intuitive system delivers quick and precise results, utilizing advanced microarray panels capable of processing up to 425 results per hour. With a continually expanding test portfolio, the platform is dedicated to maximizing workflow efficiency and expediting the diagnostic process.
Learn More About AliveDx
If you’re interested in learning more about the diagnostic solutions developed by AliveDx, visit Alivedx.com for additional information.
A Closer Look at AliveDx
AliveDx is driven by the mission to redefine diagnostic insights and adapt to the ever-changing healthcare landscape. With over thirty years of experience in in-vitro diagnostics, we are committed to pioneering innovative solutions that enable timely diagnosis and enhance patient care globally. Our brands, including Alba, MosaiQ®, and LumiQ™, reflect our dedication to providing a comprehensive and cutting-edge diagnostic framework. Whether through automating laboratory workflows or delivering swift, accurate results, we strive to transform clinical decision-making to improve overall health outcomes.
*1 Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76.
© AliveDx Suisse SA. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex, are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Subject to regulatory clearance.
Frequently Asked Questions
What does the IVDR-CE mark mean for AliveDx?
The IVDR-CE mark indicates that AliveDx's MosaiQ AiPlex™ CD microarray immunoassay complies with the strict safety and effectiveness standards set by the European Union, allowing for its use in clinical settings.
How does celiac disease impact individuals?
Celiac disease is an autoimmune disorder that damages the small intestine when gluten is ingested, leading to various symptoms and potential long-term health complications.
What are the main features of the MosaiQ AiPlex CD assay?
The MosaiQ AiPlex CD assay simplifies the diagnostic process by testing multiple autoantibodies from a single blood sample, providing quick and comprehensive results that enhance testing efficiency.
Who can benefit from the MosaiQ AiPlex CD immunoassay?
This assay is beneficial for healthcare providers aiming to improve diagnostic accuracy and speed for patients suspected of having celiac disease.
What are AliveDx's plans for its diagnostic offerings in the future?
AliveDx intends to further broaden its MosaiQ autoimmune and allergy portfolio, enhancing its capabilities to meet the increasing demand for rapid and reliable diagnostic solutions.
