Landmark First Research Test Kit for Systemic Sclerosis Launched

A novel combination of biomarkers has been developed into a test kit to facilitate diagnostics research of systemic sclerosis specifically and complex autoimmune diseases in general.

Protagen AG (Dortmund, Germany), dedicated to development of novel diagnostic and companion diagnostic tests to provide better and earlier diagnosis of severe autoimmune diseases, has launched its first ELISA, currently research-use-only, test kit – the ADx SSc Multilisa – for Systemic Sclerosis (SSc; also termed scleroderma), a complex, multi-organ rheumatic disease in which autoimmune dysregulation leads to a complex pattern of organ-specific complications associated with high mortality and morbidity. Protagen developed the new assay to synergistically combine 2 proprietary, novel disease markers with 2 standard diagnostic markers to support medical research in autoimmune diseases.

Stefan Müllner, CEO of Protagen AG, said, “Based on our long track record in the discovery and validation of autoantigen biomarkers using the proprietary SeroTag technology, our development pipeline is built on a strong patent portfolio and designed to support clinical research, targeted therapy, and the continuous delivery of novel diagnostic products.” The 3 most frequently observed autoantibodies are only present in about 60%-70% of SSc patients: anti-topoisomerase I (anti-Scl70), anti-centromere (ACA), and anti-RNA polymerase III (ARA). Protagen has focused on the identification of a new class of biomarkers for SSC to augment current diagnostic tools. Extensive research via the company´s SeroTag platform revealed 2 novel SSc-associated antigens: KDM6B and BICD2. The ADx SSc Multilisa kit enables simultaneous qualitative in vitro detection of antibodies against domains of Scl-70 (topoisomerase I),CENP-B, KDM6B, and BICD2, within human serum or plasma.

SSc is one of a number of complex autoimmune diseases that Protagen is working to address with tools to help clinical researchers identify markers for improved diagnostic and this new introduction represents a key milestone in the company’s pipeline. Mr. Müllner added, “This underscores our strategy to provide new, improved solutions and product options in autoimmune indications on a continuous basis, enable better therapeutic decision making, and improve the diagnostic process for clinicians and, importantly, patients.”

ADx SSc Multilisa is currently intended for use as a scientific research-use-only (RUO) tool, and is in further clinical testing to build a diagnostic claim for early disease detection or stratification from August 2014.

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