Today AlivedX announced that the US Food and Drug Administration (FDA) (FDA) is a 510 (K) advance registration (Premarket Notification) for the Mosaiq Aiplex® Connective Tissue Diseases (CTDPLUS) has submitted Microarray. The Mosaiq Aiplex CTDPLUS Multiplex Assay, which in February 2025 IVDR CE certification has been developed to improve the accuracy and speed of the systematic diagnosis of connective tissue diseases and at the same time simplify the work processes in the laboratory.
Systemic rheumatic autoimmune diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus, systemic sclerosis (also known as scleroderma), Sjögren syndrome, idiopathic inflammatory myopathies and mixed connective tissue affect millions of people worldwide and are related to the production of autoantic porridge. The diagnosis of these diseases is complex due to the overlapping clinical symptoms and the high frequency of the common occurrence of various connective tissue diseases1.
Fast, simple, comprehensive
The MosaiQ solution was developed for a simple workflow and quick results. The combination of several relevant markers in a single test enables usable knowledge for better patient care, reduces manual time and minimizes the use of consumption materials. For connective tissue diseases, the multiplex assay is designed in such a way that it can quickly detect and identify up to 1,275 disease markers per hour. Seamless, microarray-internal calibration and quality control as well as external quality controls with several components can further simplify the work processes in the laboratory. All reagents and multiplex microarray magazines are equipped with RFID tags to save time and avoid manual mistakes.
Unique combination of tests The Mosaiq Aiplex CTDPLUS test enables health service providers a syndromal approach and a precise serological assessment of rheumatoid arthritis (RA) and systemic connective tissue diseases (CTD). The unique combination of autoantibody tests offers a sensitive and specific diagnostic solution that provides the doctors usable knowledge for improved patient care. It can create these results with only 10 μl patient in a single step. The Mosaiq Aiplex CTDPLUS Microarray contains 15 markers in a panel for each patient, including most of the autoantibody2-6 recommended in the relevant clinical guidelines (ACR/Eular)*. The MosaiQ Aiplex CTDPlus solution enables the simultaneous detection of autoantibodies against DFS70/LEDGF, CCP, DSDNA, SM, SM/RNP, U1RNP, Chromatin, Ribosomal P, SS-A 60 (Ro60), SS-B (LA), Trim21 (Ro52), No. RNA polymerase III.
A significant step to offer our customers added value Manuel O. Méndez, CEO out Alivedx: “We are very happy that the Mosaiq Aiplex® CTDPLUS Microarray to submit the FDA to 510 (K) approval. Since the diagnosis of autoimmune diseases often takes more than four years, there is an urgent need for a multiplexes and syndromal approach to accelerate the process. The Mosaiq Aiplex CTDPLUS Microarray faces this challenge by enabling early detection of diseases and supporting more effective, effective treatments – and thus gives patients the urgently needed relief. With our Mosaiq Aiplex Celiac Microarray, which is already being checked by the FDA, today’s submission brings us a significant step closer to the provision of clinical and economic benefits for customers in the USA.”
Information on Alivedx Alivedx has set itself the task of gaining diagnostic knowledge, improving patient care and creating innovations for life. With more than 30 years of experience in in-vitro diagnostics, we devote ourselves to the design of the future of global diagnostics in the field of autoimmune diseases, allergies and beyond. Our innovative solutions enable laboratories and clinics to accelerate diagnoses, improve patients and at the same time to promote a positive and sustainable work environment for health service providers. Our portfolio includes the Alba, Mosaiq and Lumiq brands. These solutions aim to generate both economic and clinical benefits by simplifying laboratory processes and providing fast, precise results that improve clinical decision -making. At AlivedX we develop innovations for life.
Information on the Mosaiq solution The MosaiQ solution is a state-of-the-art IVD solution for autoimmune diseases, allergies and beyond. The multiplexes, fully automatic planar microarray platform enables syndomic tests for complex diseases. This intuitive platform offers a high throughput with continuous random access and provides quick and precise results that meet the increasing expectations of laboratory efficiency.
Further information on Alivedx and his IVD solutions can be found on www.alivedx.com Or if you get us on LinkedIn and X consequences.
© Alivedx Suisse Sa. 2025. The Alivedx-Logo, Alivedx, Mosaiq, Mosaiq Aiplex and Lumiq are brands or registered brands of the Alivedx Group in different countries. Changes to the menus and possibilities are reserved. Not all methods may be available in all areas. Subject to the official approval.
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 push. 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. Aletah d et al. Arthritis Rhubizard. 2010; 62 (9): 2569-81.
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