NEW YORK – Werfen announced recently that its subsidiary Inova Diagnostics has secured US Food and Drug Administration 510(k) clearance for a blood-based immunoassay reagent used to aid the diagnosis of connective tissue diseases.
Barcelona, Spain-based Werfen said the Aptiva Connective Tissue Disease (CTD) Essential reagent complements its previously cleared Aptiva Celiac Disease reagent by allowing detection of more than 60 analytes connected with additional autoimmune diseases. The reagent is designed for use with Inova's fully automated high-throughput Aptiva multi-analyte system, and the firm said the instrument and reagent can be used in combination for throughput of up to 600 results per hour with minimal hands-on time.
"Aptiva CTD Essential, with its unique biomarker composition and high level of analytical and clinical performance, represents a breakthrough that fundamentally enhances the utility of diagnostic testing in the autoimmune laboratory," Werfen Research and Business Development VP Michael Mahler said in a statement.
According to the FDA's clearance document, the reagent consists of 10 multiplexed immunoassays that are used with particle-based multi-analyte technology for quantitative determination in serum of IgG autoantibodies against dsDNA and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P. The results are used to aid the diagnosis of mixed connective tissue disease, systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, and idiopathic inflammatory myositis.