Protagen AG, a company dedicated to the development of powerful diagnostic tools to address some of the most severe autoimmune diseases, has today launched its first ELISA research use test kit for Systemic Sclerosis (SSc), the ADx^®SSc Multilisa^®.

Protagen developed the new assay to synergistically combine two proprietary, novel disease markers with two 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.”

Systemic sclerosis is one of a number of complex autoimmune diseases that Protagen is working to address with research tools to help clinical researchers in their work to identify markers for improved diagnostics. This new introduction represents a key milestone in the company’s pipeline. 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 intended for use as a scientific research-use only (RUO) product, and is in further clinical testing to build a diagnostic claim for early disease detection or stratification from August 2014.

About Systemic Sclerosis

Systemic sclerosis (SSc; also termed scleroderma) is a complex, multisystem rheumatic disease in which autoimmune-induced inflammation, fibrosis and vasculopathy lead to a complex pattern of organ-specific complications associated with high mortality and morbidity. Autoimmune dysregulation includes lymphocyte activation that causes autoantibody production, aberrant cytokine and chemokine release, excessive collagen deposition and subsequent atrophy of the skin, subcutaneous tissue and internal organs (e.g. lung, heart, kidney). Susceptibility to SSc clearly depends on complex host factors as well as environmental triggers; these predisposing factors, and the clinical symptoms, overlap with those of other disease states, especially other autoimmune rheumatic diseases.

About Protagen – Diagnostics Differentiated

Protagen AG, headquartered in Dortmund, Germany, specializes in the development of novel diagnostic and companion diagnostic tests to provide better and earlier diagnosis of autoimmune diseases.

Protagen uses its proprietary SeroTag^® biomarker platform to identify disease specific autoantibodies and is on target to become the leading provider of autoimmune diagnostic products, specifically targeting diseases with an unmet need for effective diagnostics. With pioneering bioscience techniques, extensive scientific expertise and a broad patent portfolio, Protagen works to develop its own diagnostic pipeline and partners with other organizations to develop and implement new companion diagnostic tools for better personalized treatment strategies.

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