Germany-based medical technology company Protagen has secured the CE mark for its Multilisa BICD2 test for Systemic Sclerosis (SSc).
The BICD2 test is the first patented biomarker operating on the SeroTag technology platform, which offers new and patented biomarkers to define autoimmune diseases at the molecular level.
Aside from the classical markers such as anti-Centromere antibodies and anti-Scl70 antibodies, BICD2 autoantibodies can be detected in approximately 30% of patients suffering from SSc, and are highly associated with the limited form of SSc.
SSc is a rare systemic autoimmune disease that takes the form of progressive fibrosis spreading across the skin and internal organs.
It is marked by several specific autoantibodies in intracellular targets, which occur in roughly 80% of patients.
The clinical management of SSc requires the understanding of the autoantibody mechanisms as it is significantly related to the organ involvement and disease outcome.
Protagen CEO Dr Stefan Müllne 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 is why we have 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."
The Multilisa BICD2 ELISA is designed for the semi-quantitative determination of autoantibodies to BICD2, which is an evolutionarily conserved motor adaptor protein involved in the dynein-mediated transport process.