NEW YORK – AliveDx, formerly Quotient, said Tuesday that it received CE markings for two multiplexed microarray immunoassays used to aid diagnosis of connective tissue diseases.
The Eysins, Switzerland-based firm's MosaiQ CENP-B immunoassay is used to detect autoantibodies to centromere protein B, and its MosaiQ AiPlex CTD (connective tissue diseases) assay is used to detect autoantibodies 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 to aid the diagnosis of diseases including systemic lupus erythematosus, Sjögren’s syndrome, scleroderma, polymyositis/dermatomyositis, and mixed connective tissue disease. The firm also secured CE marking for its MosaiQ AiPlex CTD Quality Controls.
The MosaiQ CENP-B and AiPlex CTD immunoassays are designed for use on AliveDx's fully automated high-throughput MosaiQ microarray platform.
"This approval confirms the MosaiQ solution flexibility to address various disease areas and simplify testing algorithms," AliveDx CEO Manuel Méndez said in a statement.
He added that the firm plans to expand its portfolio of tests in the near future.
In December 2022, Quotient Limited announced it would file to delist its shares from the Nasdaq Global Market Exchange and lay off 100 employees. The firm announced this July that it was rebranding as AliveDx with a focus on developing innovative tests that could reduce the time to diagnosis.