New diagnostic test for systemic sclerosis

Systemic sclerosis (SSc; also termed scleroderma) is a complex, multisystem rheumatic disease in which autoimmune-induced inflammation, fibrosis and vasculopathy cause organ-specific complications linked to high mortality and morbidity. As a complex disease associated a wide range of symptoms, it can very difficult to diagnose with confidence.

Incidence and prevalence figures vary widely across the globe, with females affected more than males (reported prevalence in the USA is 276 per million adults versus 88 per million in the UK). Like many autoimmune diseases, chronic SSc can be extremely unpleasant and painful.

Protagen’s new assay combines two proprietary, novel disease markers with two standard diagnostic markers to generate a tool for supporting medical research into autoimmune diseases such as SSc.

ADx SSc Multilisa assay enables the simultaneous, qualitative, in vitro detection of antibodies

The new ADx SSc Multilisa assay employs the company’s biomarker development platform to enable the simultaneous, qualitative, in vitro detection of antibodies against domains of Scl-70 (topoisomerase I), CENP-B, KDM6B, and BICD2, within human serum or plasma. ADx SSc Multilisa is intended for use as a scientific research-use only (RUO) product. However, it is currently in further clinical testing to build a diagnostic claim for early disease detection or stratification from August 2014.

Systemic sclerosis is one of a number of complex autoimmune diseases that Protagen is working to address, with the company also looking to alleviate the unmet need for improved diagnostic tools in diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS) and multiple sclerosis (MS). As such, the launch of this first assay represents a key milestone in the company’s pipeline.
 
AADx 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.

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