Salute e Benessere
AliveDx announces US FDA 510(k) submission for MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) multiplex microarray
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 connective tissue diseases, the multiplex assay is designed to rapidly detect and identify up to 1275 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.
The MosaiQ AiPlex CTDplus assay enables a syndromic approach and accurate serological evaluation of Rheumatoid Arthritis (RA) and systematic connective tissue diseases (CTD) for healthcare providers. Its unique combination of autoantibody tests offers a sensitive and specific diagnostic solution, assisting clinicians with actionable insights for improved patient care. It can generate these results with only 10 μl patient in one single step. MosaiQ AiPlex CTDplus microarray includes 15 markers in one panel for each patient, including the majority of autoantibodies recommended by the relevant clinical guidelines (ACR/EULAR)* . The MosaiQ AiPlex CTDplus solution enables the simultaneous detection of autoantibodies directed to DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, Chromatin, Ribosomal P, SS-A 60 (Ro60), SS-B (La), TRIM21 (Ro52), Jo-1, CENP-B, Scl-70 and RNA Polymerase III.
Manuel O. Méndez, CEO of 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.
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. Nathalie Conrad et al. Lancet 2023; 401: 1878–90 *ACR: American College of Rheumatology. EULAR: European Alliance of Associations for Rheumatology.
2. Aringer M et al. Ann Rheum Dis. 2019;78(9):1151-9.
3. Shiboski CH et al. Arthritis Rheumatol. 2017;69(1):35-45.
4. van den Hoogen F et al. Arthritis Rheum. 2013;65(11):2737-47.
5. Lundberg IE et al. Arthritis Rheumatol. 2017;69(12):2271-82.
6. Aletaha D et al. Arthritis Rheum. 2010;62(9):2569-81.
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