Systemic sclerosis (SSc; also termed scleroderma) is a rare, complex, multi-organ autoimmune disease which manifests as progressive fibrosis of the skin and internal organs and has a high unmet diagnostic need. The disease is associated with the presence of several specific autoantibodies to intracellular targets. The three most frequently observed autoantibodies are only present in about 60-70% of SSc patient’s, anti-topoisomerase I (anti-Scl70), anti-centromere (ACA) and anti-RNA polymerase III (ARA). 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.
Using its SeroTag® platform, Protagen has focused on the identification of a new class of biomarkers for SSc to augment current diagnostic tools. Extensive research revealed several novel SSc-associated antigens. The first of which, BICD2, is now available as a CE-Mark assay and adds to our portfolio, which includes Scl-70 and CENP-B, two standard markers used in the diagnosis of SSc. Together this panel of IVD assays can provide significant improvements to current diagnostic tests with the ability to better distinguish between different forms of the disease.
The proprietary biomarker BICD2 is also available for licensing. Contact our team to further discuss licensing opportunities.