Germany-based Protagen has received CE mark approval for its Multilisa BICD2 test to diagnose systemic sclerosis (SSc).
SSc is a rare systemic autoimmune disease, which manifests as progressive fibrosis of the skin and internal organs.
Multilisa BICD2 ELISA will be used for the semi-quantitative determination of autoantibodies to BICD2, a motor adaptor protein involved in the dynein-mediated transport process.
Protagen discovered the BICD2 biomarker by using the SeroTag technology platform, which delivers novel and proprietary biomarkers to define autoimmune diseases at the molecular level.
The biomarker platform, which enables to identify disease specific autoantibodies, provides autoimmune diagnostic products to specifically target diseases with an unmet need for effective diagnostics.
Protagen CEO Dr Stefan Müllner said: "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.
"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."
Protagen is engaged in the development of novel diagnostic and companion diagnostic tests, which will be used in the diagnosis of autoimmune diseases.
Image: Protagen’s Multilisa BICD2 test will be used to diagnose systemic sclerosis. Photo: courtesy of Suwit Ritjaroon / FreeDigitalPhotos.net.