New Biomarker Assay to Aid in Systemic Sclerosis Diagnosis

New Biomarker Assay to Aid in Systemic Sclerosis Diagnosis

Protagen AG, a leader in the development of novel molecular diagnostics for autoimmune diseases, recently launched the Multilisa BICD2, an ELISA (enzyme-linked immunosorbent assay) that together with clinical symptoms will aid on the diagnosis of systemic sclerosis (SSc).

SSc is a complex, multi-organ autoimmune disease characterized by increased fibroblast activity that results in abnormal growth of connective tissue, causing vascular damage and fibrosis. Fibrosis can occur in the skin, the gastrointestinal (GI) tract and other internal organs. The clinical manifestations of SSc are extremely heterogeneous and dependent on the presence and degree of organ involvement. SSc is a rare disorder, with an annual incidence in the United States of about 20 cases in every 1 million adults.

SSc is associated with the presence of several specific autoantibodies against intracellular targets that occur in approximately 80% of the patients. Autoantibody specificities are strongly associated with disease outcome and patterns of organ involvement. As a result, these antibodies are an important tool for SSc management.

Protagen uses its proprietary SeroTag biomarker platform to identify disease-specific autoantibodies. The recently discovered anti-BICD2 autoantibodies are found in about 30% of SSc patients, and are greatly associated with limited forms of the disease (affecting the hands, forearms, face and feet). Beyond the standard markers such as Centromere and Scl70, BICD2 is the most abundant target of autoantibodies in SSc patients.

The Protagen Multilisa BICD2 was developed to semi-quantitatively determine IgG antibodies exclusive for the BICD2 protein, an evolutionarily conserved motor adaptor protein involved in intracellular transport. Anti-BICD-2 antibodies appear to correlate with a mild disease course.

“With Multilisa® BICD2, we proudly present the first proprietary marker out of the SeroTag® platform in an easy to use ELISA format. We selected Systemic Sclerosis on purpose for our first product given the high medical and diagnostic need in this indication,” said Dr. Stefan Müllner, CEO of Protagen, in a press release. “In addition, we have evidence that BICD2 autoantibodies are found predominantly in patients without lung fibrosis and from further studies do expect that our novel marker will have a significant impact on the management of SSc patients in the future.”

Protagen recently presented this new assay at MEDICA 2015, the world’s largest medical trade fair.

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