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Werfen Secures CE Marking for Autoimmune Disease Reagent

NEW YORK – Werfen on Monday said it secured CE marking for immunoassay reagents that are used to help determine which patients have antiphospholipid syndrome (APS), a difficult-to-diagnose autoimmune disease.

The Barcelona, Spain-based firm said its Aptiva APS IgG and APS IgM reagents are used for the semiquantitative determination in serum or plasma of anti-cardiolipin and anti-beta 2 glycoprotein 1 IgG and IgM autoantibodies. The results are used to aid the primary and secondary diagnosis of APS when the results are used along with other laboratory findings.

Michael Mahler, VP of research and development for Werfen, said APS can manifest as venous or arterial thrombosis and can result in fetal loss, and the disease can be difficult to diagnose because its symptoms mimic other conditions.

The reagents are designed for use on Werfen's fully automated high-throughput Aptiva analyzers using the firm's particle-based multi-analyte technology. The firm said it now has 19 analytes with CE marking for detection on the Aptiva instrument, which can deliver up to 120 APS results per hour.

Werfen officials noted that the current lineup includes reagents for celiac disease and connective tissue diseases. The firm also has more than 60 analytes in advanced development for use in improving the accuracy of autoimmune disease diagnosis and supporting patient management.

Werfen also said in October 2023 that its Inova Diagnostics subsidiary had received US Food and Drug Administration 510(k) clearance for its Aptiva Connective Tissue Disease (CTD) Essential reagent that consists of 10 multiplexed immunoassays that are used to aid the diagnosis of mixed connective tissue disease, systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, and idiopathic inflammatory myositis.