https://alivedx.com/press-releases/alivedx-receives-three-ivdr-ce-marks-for-its-multiplexed-autoimmune-diagnostics-solution/

AliveDx receives three IVDR CE Marks for its automated, multiplexed MosaiQ® solution, enabling faster diagnosis of Connective Tissue Diseases (CTD).

• The MosaiQ CENP-B microarray immunoassay designed for the detection of Auto-antibodies to Centromere Protein B.
• The MosaiQ AiPlex CTD microarray immunoassay designed as an aid in diagnosis of Connective Tissue Diseases.
• The multiconstituent MosaiQ AiPlex CTD Quality Controls.

Eysins, 30 October 2023 — AliveDx is proud to announce it has received three CE Marks for: Its MosaiQ Centromere Protein B (CENP-B) microarray,its MosaiQ AiPlex CTD (Connective Tissue Diseases) multiplexed microarray immunoassays and its 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.

Economic and Clinical Value through multiplexed testing with MosaiQ AiPlex CTD microarray

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