Protagen AG, a leading specialist in the development of novel diagnostic tests and companion diagnostics in the autoimmune field, today launched Multilisa^® BICD2 a research use only (RUO) ELISA to aid in the diagnosis of Systemic Sclerosis (SSc).

The SeroTag^® platform of Protagen continuously delivers novel and proprietary markers helping to define autoimmune diseases on the molecular level. The newly discovered anti-BICD2 autoantibodies originate from this platform and are found in approximately 30% of patients with SSc. Anti-BICD2 autoantibodies are highly associated with the limited form of SSc and, behind the classical markers such as anti-Centromere antibodies and anti-Scl70 antibodies, are the most abundant autoantibodies in patients with SSc.

The Protagen Multilisa^® BICD2 is intended for the semi-quantitative determination of IgG antibodies specific for the BICD2 protein, an evolutionarily conserved motor adaptor protein involved in the dynein-mediated transport process.

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

"With Multilisa^® BICD2, we proudly present the first proprietary marker out of the SeroTag^® platform in an easy to use ELISA format. We selected Systemic Sclerosis on purpose for our first product given the high medical and diagnostic need in this indication," added Dr. Stefan Müllner, CEO of Protagen. "In addition, we have evidence that BICD2 autoantibodies are found predominantly in patients without lung fibrosis and from further studies do expect that our novel marker will have a significant impact on the management of SSc patients in the future.”

Protagen presented this novel assay at medica 2015.

more about protagen