Protagen Announces CE Mark for its Proprietary Multilisa® BICD2 Test

The SeroTag® platform continuously delivers novel and proprietary biomarkers to define autoimmune diseases at the molecular level. BICD2 autoantibodies are found in approximately 30% of patients with SSc, and are highly associated with the limited form of SSc. Beyond the classical markers such as anti-Centromere antibodies and anti-Scl70 antibodies, BICD2 autoantibodies are most abundant in SSc patients.

The Multilisa® BICD2 ELISA is intended for the semi-quantitative determination of autoantibodies to BICD2, an evolutionarily conserved motor adaptor protein involved in the dynein-mediated transport process.

SSc is a rare systemic autoimmune disease that manifests as progressive fibrosis of the skin and internal organs. The disease is associated with the presence of several specific autoantibodies to intracellular targets, which occur in around 80% of patients. As autoantibody specificities are strongly associated with patterns of organ involvement and disease outcome, understanding their mechanisms are an essential tool in the clinical management of SSc.

"The launch of the CE-marked Multilisa® BICD2 underscores the high performance of the SeroTag® platform in delivering novel biomarkers and diagnostic assays. We understand the high medical and diagnostic need for SSc, and that’s why we’ve chosen to target this disease with our first Dx assay portfolio” said Dr. Stefan Müllner, CEO of Protagen. "Together with the recently launched CE-marked Multilisa® CENP-B and Multilisa® Scl-70, we are now offering a comprehensive assay portfolio for the improvement of SSc diagnosis and patient care.”