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AliveDx gets FDA approval for MosaiQ AiPlex CTDplus assay
AliveDx has submitted a 510(k) premarket notification to the US FDA for its MosaiQ AiPlex CTDplus microarray, designed to enhance the diagnosis of systemic connective tissue diseases (CTDs). This multiplex assay aims to improve diagnostic speed and precision while streamlining laboratory workflows. Targeting autoimmune diseases like rheumatoid arthritis, scleroderma, and inflammatory myopathies, the solution integrates multiple markers into a single test for efficient analysis.
The MosaiQ platform claims to deliver faster results, reduce hands-on time, and minimise consumable use, processing up to 1,275 disease markers per hour. It adopts a syndromic approach, helping clinicians assess CTDs and rheumatoid arthritis more effectively. Each patient panel includes 15 markers, covering key autoantibodies outlined in leading clinical guidelines. These include CCP, dsDNA, and DFS70/LEDGF.
With autoimmune diagnoses often delayed for years, this tool supports earlier detection and targeted treatment. The assay received IVDR-CE mark certification in February 2025.
08-04-2025