Protagen Launches First CE Marked Diagnostic Assays

The Protagen Multilisa® SSc program combines novel and proprietary markers with existing diagnostic standards to help understand the condition at a molecular level. Multilisa® CENP-B and Multilisa® Scl-70 are intended for the semi-quantitative determination of IgG antibodies specific for the CENP-B and Scl-70 proteins. Analysis of autoantibodies against both proteins is part of the guidelines for the diagnosis and treatment of SSc patients. The presence of these autoantibodies in the serum of SSc patients is almost mutually exclusive and each antibody defines specific sub-forms of SSc. Together they are able to help in the diagnosis of around 70% of SSc patients.

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® CENP-B and Multilisa® Scl-70, we present the first Protagen CE marked diagnostic assays in an easy to use ELISA format. We selected SSc for our first product development program due to the high medical and diagnostic need in this indication," said Dr. Stefan Müllner, CEO of Protagen. "These generic markers are part of the SSc guidelines and it is therefore necessary to include them in a comprehensive product offering. We will follow this launch with further proprietary markers to support physicians in their quest to significantly impact on and improve the management of SSc patients.”