AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Celiac Disease (CD) multiplex microarray

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The MosaiQ AiPlex CD is designed to improve the accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows

EYSINS, Switzerland, Feb. 10, 2025 /PRNewswire/ -- AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex^® Celiac Disease (CD) microarray.

The MosaiQ AiPlex CD multiplex assay, which received IVDR-CE mark certification in August 2024, is designed to improve the accuracy and speed of celiac disease diagnosis while simplifying laboratory workflows. The assay enables a syndromic approach.

Celiac disease is a chronic autoimmune disorder with a global prevalence of 1 in 100¹, 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.

MosaiQ AiPlex CD multiplex assay: Fast, Easy, Comprehensive
The MosaiQ AiPlex CD assay enables a syndromic approach and simplified serological evaluation (rule in or rule out) of celiac disease for healthcare providers. The panel combines both IgA and IgG isotypes, providing comprehensive analysis for each patient with only 20 μl patient sample in one step. It offers a sensitive and specific diagnostic solution, assisting clinicians with actionable insights for improved patient care.
Our CD microarray includes 5 markers in one panel for each patient, including the majority of autoantibodies recommended by the relevant clinical guidelines (ESsCD, ACG and ESPGHAN)*^2-5. The MosaiQ AiPlex CD assay provides important insights and simultaneous detection of IgA deficiency and values in AU/ml for anti-tTG and anti-DGP for both IgA and IgG isotypes. IgA deficiency prevalence can be up to 15 times higher in celiac patient populations.

"We're excited to submit the MosaiQ AiPlex^® Celiac Disease (CD) microarray to the FDA for 510(k) clearance. Considering that the average time to diagnose an autoimmune disease can exceed four years, the need for a multiplexed solution to accelerate diagnosis is essential. The MosaiQ AiPlex CD solution addresses this need by enabling early disease detection and facilitating more targeted and effective treatments, offering much-needed relief to patients," said Manuel O. Méndez, CEO of AliveDx. "Today's submission brings us one step closer to delivering this groundbreaking solution to customers in the United States of America."

The MosaiQ solution has been designed to provide simple workflow and fast results. Combining multiple relevant markers into one single test enables actionable insights for better patient care, as well as reducing significant hands-on time and minimizing consumable usage. For Celiac Disease, the multiplex assay is designed to rapidly detect and identify up to 425 disease markers per hour. Seamless, microarray-internal calibration and quality control as well as multi-constituent, external quality controls can further help simplify laboratory workflows. All reagents and multiplex microarray magazines are equipped with RFID tags to save time while avoiding manual errors. 

About AliveDx

At AliveDx, our mission is to empower diagnostic insights, transform patient care, and innovate for life. With over 30 years in in-vitro diagnostics, we are dedicated to shaping the future of global diagnostics in autoimmune, allergy, and beyond. Our innovative solutions empower laboratories and clinicians to accelerate diagnosis, improving patients' lives while fostering a positive and sustainable work environment for healthcare providers. Our portfolio includes the Alba, MosaiQ and LumiQ brands. These solutions aim to generate both economic and clinical value by simplifying laboratory workflows and providing fast, accurate results that enhance clinical decision-making. At AliveDx, we innovate for life.

About the MosaiQ solution

The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexed, fully automated planar microarray platform enables syndromic testing for complex conditions. This intuitive platform offers high throughput with continuous random access, delivers fast and accurate results addressing evolving expectations for laboratory efficiency.

For more information about AliveDx and its IVD solutions, please visit www.alivedx.com and connect with us on LinkedIn and X.

©AliveDx Suisse SA. 2025. The AliveDx logo, AliveDx, MosaiQ, MosaiQ AiPlex, and LumiQ are trademarks or registered trademarks of AliveDx group companies in various jurisdictions. Menus and capabilities are subject to change. Not all methods may be available in all territories. Subject to regulatory clearance. 

^1. Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76. ^2. Al-Toma A et al. United European Gastroenterol J. 2019;7(5):583-613. ^3. Rubio-Tapia A et al. Am J Gastroenterol. 2023;118(1):59-76. ^4. ESsCD: European Society for the Study of Coeliac Disease ^5. ACG: American College of Gastroenterology ^6. ESPGHAN: European Society for Pediatric Gastroenterology Hepatology and Nutrition