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AliveDx Gets CE-IVDR Mark for Systemic Autoimmune Rheumatic Disease Test

NEW YORK — AliveDx said Tuesday that it has received CE-IVDR marking for a multiplex immunoassay for the diagnosis of systemic autoimmune rheumatic diseases (SARDs).

SARDs include rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome, and idiopathic inflammatory myopathies. Their overlapping clinical symptoms and frequent comorbidity with a range of connective tissue diseases make them difficult to diagnose, AliveDx said.

AliveDx's MosaiQ AiPlex CTDplus multiplex assay is designed to detect 15 different autoantibodies in serum including DFS70/LEDGF; CCP; dsDNA; Sm; Sm/RNP; U1RNP; chromatin; ribosomal P; SS-A 60; SS-B; TRIM21; Jo-1; CENP-B; Scl-70; and RNA polymerase III. It runs on the Swiss company's fully automated high-throughput MosaiQ System.

"We are excited to receive our fifth clinical IVDR-CE mark in the last 18 months," AliveDx CEO Manuel Méndez said in a statement. "Looking ahead, we plan to expand our offering with a vasculitis and antiphospholipid multiplex solution to enhance the diagnosis of systemic autoimmune diseases."

In September, Switzerland-based AliveDx received CE-IVDR marking for its MosaiQ AiPlex CD microarray immunoassay for celiac disease. A few months before that, it nabbed a CE-IVDR mark for a MosaiQ platform immunoassay for allergy diagnosis.