AliveDx has obtained three IVDR CE marks for its automated MosaiQ solution, facilitating the rapid diagnosis of connective tissue diseases (CTD).
The CE Marks were granted to MosaiQ Centromere Protein B (CENP-B) microarray, MosaiQ AiPlex CTD multiplexed microarray immunoassays and MosaiQ AiPlex CTD Quality Controls.
The MosaiQ CENP-B microarray immunoassay is suitable for the identification of auto-antibodies to Centromere Protein B.
AliveDx’s MosaiQ AiPlex CTD microarray immunoassay is intended for the detection of auto-antibodies to native, double-stranded DNA, Sm, SS-A (Ro-60), U1RNP, Trim-21 (Ro-52), SCL-70, Jo-1, SS-B, Sm/RNP, Centromere Protein B and Ribosomal P.
It helps in the diagnosis of various CTDs, including Sjögren’s Syndrome, scleroderma (systemic sclerosis, SSc), systemic lupus erythematosus (SLE), mixed CTD and polymyositis/dermatomyositis.
The MosaiQ solution integrates a smart image analysis algorithm, planar multiplexed microarray technology and a fully automated, high-throughput instrument platform to facilitate rapid turnaround times for complex diagnostic pathways.
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By introducing its autoimmune testing portfolio in the European Union and other regions where the CE mark is recognised, the company is offering laboratories and hospitals a new in-vitro diagnostics solution to expedite the diagnosis and treatment of patients with autoimmune diseases.
AliveDx CEO Manuel Méndez said: “We are excited to receive the CE mark for our initial clinical multiplexed microarrays. This approval confirms the MosaiQ solution’s flexibility to address various disease areas and simplify testing algorithms.
“We look forward to expanding our portfolio in the near future. We are committed to empowering diagnostic insights, transforming patient care and innovating for life.”