AliveDx Achieves IVDR-CE Mark for Groundbreaking Celiac Test
AliveDx Celebrates IVDR-CE Mark for Celiac Disease Detection
At AliveDx, we’re thrilled to announce a significant milestone in our mission to revolutionize diagnostics. Our innovative MosaiQ AiPlex™ CD microarray immunoassay has recently achieved the IVDR-CE mark certification, a testament to its safety and efficacy in accurately diagnosing celiac disease. This certification adheres to the stringent IVDR standards set by the European Union, paving the way for its expanded clinical use in various jurisdictions accepting the CE mark. This advancement not only fosters better patient care but also enhances the lives of those grappling with celiac disease.
Celiac Disease: A Widespread Health Issue
Celiac disease is a chronic autoimmune disorder that affects approximately 1 in 100 individuals globally. It imposes numerous health challenges, often leading to diverse multiorgan symptoms. The condition is instigated by an unhealthy immune response to gluten in genetically predisposed individuals, which can ultimately lead to intestinal damage and a host of other complications. As such, an accurate and timely diagnosis is vital for effective management and improved patient outcomes.
Diagnostic Challenges and Protocols
To diagnose celiac disease, healthcare professionals typically rely on serological testing for specific autoantibodies. The standard practice recommends the testing of IgA autoantibodies against tissue Transglutaminase (anti-tTG IgA) and Deamidated Gliadin Peptides (anti-DGP IgA). Given that a subset of individuals may present with selective IgA deficiency, it’s critical to evaluate total IgA levels too, which can refine the diagnostic accuracy. When IgA levels are insufficient, testing IgG autoantibodies such as anti-tTG IgG is advised.
Streamlined Workflow and Rapid Results
Our newly IVDR-CE marked MosaiQ AiPlex CD microarray immunoassay is a game changer—it provides healthcare practitioners with a powerful tool to expedite the diagnostic process for celiac disease. It combines testing for essential autoantibodies including tTG IgA, DGP IgA, tTG IgG, and DGP IgG, all from a single blood sample. This not only enhances the diagnostic insights but also allows laboratories to streamline operations, significantly reducing the wait time for patients. Early diagnosis can lead to prompt intervention through a Gluten-Free Diet (GFD), alleviating gastrointestinal symptoms and preventing serious health complications over time.
A Comprehensive Autoimmune Solution
The approval of MosaiQ AiPlex CD complements our existing suite of autoimmune diagnostic tools, including MosaiQ and LumiQ portfolios. As we plan for 2025 and beyond, AliveDx is committed to expanding our diagnostic capabilities further, offering a broader menu within the MosaiQ autoimmune and allergy diagnostics.
A Message from Our CEO
“We are extremely excited to receive the CE mark for our MosaiQ AiPlex CD microarray,” stated Manuel O. Mendez, CEO of AliveDx. “This achievement symbolizes our relentless dedication to advancing diagnostic technologies and highlights our commitment to supporting the millions suffering from autoimmune diseases. An early and precise diagnosis is crucial in managing this condition effectively. Our array of innovative MosaiQ microarray solutions represents a significant leap towards enhancing patient outcomes, reducing healthcare costs, and improving 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 beyond. This user-friendly system delivers rapid and precise results, employing advanced microarray panels that can process up to 425 results per hour. With a continuously evolving test portfolio, the platform is dedicated to maximizing workflow efficiency and expediting diagnosis.
Learn More About AliveDx
If you’re interested in exploring the diagnostic solutions developed by AliveDx, visit Alivedx.com for more information.
A Closer Look at AliveDx
AliveDx is driven by a mission to redefine diagnostic insights and adapt to the evolving healthcare landscape. With over three decades of experience in in-vitro diagnostics, we are committed to pioneering innovative solutions that facilitate timely diagnosis and enhance patient care worldwide. Our brands, including Alba, MosaiQ®, and LumiQ™, reflect our dedication to providing a comprehensive and state-of-the-art diagnostic framework. Whether it’s through automating laboratory workflows or delivering fast, accurate results, we aim 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 is the significance of the IVDR-CE mark for AliveDx?
The IVDR-CE mark signifies that AliveDx's MosaiQ AiPlex™ CD microarray immunoassay meets the stringent safety and effectiveness standards set by the European Union, allowing it for widespread clinical use.
How does celiac disease affect individuals?
Celiac disease is an autoimmune condition that causes damage to the small intestine when gluten is consumed, leading to a variety of symptoms and potential long-term health issues.
What are the key features of the MosaiQ AiPlex CD assay?
The MosaiQ AiPlex CD assay simplifies diagnostics by testing multiple autoantibodies from a single blood sample, delivering quick and comprehensive results that streamline the testing process.
Who can benefit from the MosaiQ AiPlex CD immunoassay?
This assay is designed for healthcare providers looking to improve diagnostic accuracy and speed for patients who are suspected of having celiac disease.
What are AliveDx's future plans for its diagnostic portfolio?
AliveDx plans to further expand its MosaiQ autoimmune and allergy portfolio, enhancing its capabilities to meet the growing demand for rapid and reliable diagnostics.
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