NEW YORK – Swiss firm AliveDx said Thursday that it has submitted for US Food and Drug Administration 510(k) marketing clearance a multiplex immunoassay that is used to aid the diagnosis of systemic autoimmune rheumatic diseases.
The firm said that the assay is used to aid the diagnosis of diseases including rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome, idiopathic inflammatory myopathies, and mixed connective tissue diseases that are associated with autoantibody production issues.
The firm's MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray assay is used for the detection of 15 disease markers, including the autoantibodies DFS70/LEDGF, CCP, dsDNA, Sm, Sm/RNP, U1RNP, chromatin, ribosomal P, SS-A 60, SS-B (La), TRIM21 (Ro52), Jo-1, CENP-B, Scl-70, and RNA polymerase III. The test is designed for use on the firm's MosaiQ System, which can detect and identify up to 1,275 biomarkers per hour.
AliveDx announced in February that it had received CE-IVDR marking in the EU for the test.
AliveDx CEO Manuel Méndez said in a statement that the FDA 510(k) submission brings the company closer to delivering clinical and economic value to its US customers.
"With autoimmune disease diagnoses often taking more than four years, there is a critical need for a multiplexed and syndromic approach to accelerate the process," he said. "The MosaiQ AiPlex CTDplus microarray addresses this challenge by enabling early disease detection and supporting more targeted, effective treatments — ultimately providing much-needed relief to patients."