Systemic Lupus Erythematosus (SLE) is a heterogeneous, inflammatory, multisystem autoimmune disease, which follows a relapsing and remitting course. A common serological feature of SLE is the production of autoantibodies. Current diagnostic methods for determining autoantibodies in SLE have mainly focused on a relatively small set of autoantibody targets of which anti-dsDNA, anti-phospholipid and anti-Sm are important criteria for the clinical diagnosis of SLE. However, there is neither a single marker nor a marker panel used as a gold standard in SLE diagnosis.
Protagen has focused on the identification of new biomarkers for SLE to augment current diagnostic tools. Extensive research revealed five novel SLE-associated antigens. The development of up to 10 standard markers used in the diagnosis of SLE with up to 5 proprietary, novel autoantigens delivered by the company´s SeroTag technology platform, are what gives the Multilisa® SLE program real power to aid medical research and support patient management in SLE.
Protagen aims to develop a gold standard marker panel with a sensitivity of at least 85% and a specificity of over 95%.The Protagen Mulitlisa SLE multiplex assay is currently in development and is expected to be launched by Q1/2017.