AliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray.
This multiplex assay is tailored to improve both the accuracy and speed of diagnosing systemic CTD, as well as the streamlining of lab workflows.
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According to the company, systemic autoimmune rheumatic conditions such as scleroderma, rheumatoid arthritis and idiopathic inflammatory myopathies affect millions of individuals globally and are often related to the production of autoantibodies.
AliveDx’s MosaiQ solution claims to offer a simplified workflow and rapid outcomes by integrating several relevant markers into one test.
This approach not only provides “actionable insights” for individual care but also minimises hands-on time and reduces consumable use.
Claiming to detect up to 1,275 disease markers an hour, the assay facilitates a syndromic approach to assess rheumatoid arthritis and systemic CTD, aiding healthcare providers in their diagnostic processes.
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By GlobalDataIncluded in the microarray are 15 markers for every patient panel, encompassing most of the autoantibodies recommended by the American College of Rheumatology and the European Alliance of Associations for Rheumatology clinical guidelines.
The assay can concurrently detect autoantibodies to a range of markers, including dense fine speckled protein of 70 kD (DFS70)/lens epithelium-derived growth factor (LEDGF), cyclic citrullinated peptide (CCP), and double-stranded DNA (dsDNA), among others.
AliveDx CEO Manuel Méndez said: “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 US.”
The assay received in vitro diagnostic device regulation (IVDR)-CE mark certification in February 2025.
