AliveDx multiplexed autoimmune diagnostics solution receives three IVDR CE marks

AliveDx has received three CE marks for: MosaiQ Centromere Protein B (CENP-B) microarray, MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and MosaiQ AiPlex CTD Quality Controls.

By launching its autoimmune testing portfolio in the European Union and other CE Mark recognizing geographies, the company is providing laboratories and hospitals with a novel in-vitro diagnostics solution to enable improved workflow and faster time to diagnosis and treatment of patients suffering from autoimmune diseases. The company is pursuing an ambitious plan to rapidly expand its clinical immunology portfolio.

The MosaiQ solution combines a fully automated, ease to use, high throughput instrument platform, proprietary planar multiplexed microarray technology, and a smart image analysis algorithm to enable faster turn-around times for complex diagnostics pathways.

The new CE-Marked MosaiQ AiPlex CTD microarray immunoassay is designed to detect Auto-antibodies to native, double-stranded DNA, Sm, U1RNP, SS-A (Ro-60), Trim-21 (Ro-52), SS-B, SCL-70, Jo-1, Sm/RNP, Centromere Protein B and Ribosomal P. Hence it aids in the diagnosis of multiple Connective Tissue Diseases, including Systemic Lupus Erythematosus (SLE), Sjögren’s Syndrome, Scleroderma (Systemic Sclerosis, SSc), Polymyositis/Dermatomyositis, and Mixed Connective Tissue Disease (MCTD).

“We are excited to receive the CE Mark for our initial clinical multiplexed microarrays. This approval confirms the MosaiQ solution flexibility to address various disease areas and simplify testing algorithms. I am thankful and proud of the AliveDx team and partners for achieving this milestone.

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,” said Manuel O. Méndez, chief executive officer of AliveDx.

AliveDx empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster disease detection to shorten the time to diagnosis.

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