AliveDx Submits FDA 510(k) for MosaiQ AiPlex® CTDplus Multiplex Microarray in the U.S.

AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex^® Connective Tissue Diseases (CTDplus) microarray. The MosaiQ AiPlex CTDplus multiplex assay, which received IVDR-CE mark certification in February 2025, is designed to improve the accuracy and speed of systematic connective tissue disease diagnosis while simplifying laboratory workflows. 

Systemic autoimmune Rheumatic Diseases such as Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus, Systemic Sclerosis (also known as Scleroderma), Sjögren's syndrome, idiopathic inflammatory Myopathies and mixed connective tissue diseases affect millions worldwide and are associated with autoantibody production. Diagnosing these conditions is complex due to overlapping clinical symptoms and high rates of co-occurrence among a range of connective tissue diseases¹.

Fast, Easy, Comprehensive
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.

Unique combination of tests
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)*^2-6. 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.

Significant step to deliver value to our customers
Manuel O. Méndez, CEO of AliveDx: "We are thrilled to submit the MosaiQ AiPlex^® CTDplus microarray to the FDA for 510(k) clearance. With autoimmune disease diagnoses often taking more than four years, there is a critical need for a multiplexed and syndromic approach to accelerate the process. The MosaiQ AiPlex CTDplus microarray addresses this challenge by enabling early disease detection and supporting more targeted, effective treatments—ultimately providing much-needed relief to patients. With our MosaiQ AiPlex Celiac Disease microarray already under review by the FDA, today's submission brings us a significant step closer to delivering clinical and economical value to customers in the USA."