PROTAGEN AG, a leading specialist in the development of novel diagnostic tests and companion diagnostics in the autoimmune field, and Inova Diagnostics, a global leader in the development and commercialization of in-vitro diagnostic systems and reagents for autoimmune diseases, have signed a semi-exclusive license agreement for BICD2, a novel autoantigen and the first proprietary biomarker discovered by Protagen employing its SeroTag® technology. 

Anti-BICD2 autoantibodies are found in approximately 30% of patients with Systemic Sclerosis (SSc), and are associated with a subform of SSc. Beyond the classical markers such as anti-Centromere antibodies and anti-Scl70 antibodies, anti-BICD2 antibodies are most abundant in SSc patients. The license agreement will allow Inova Diagnostics to add the novel biomarker to their portfolio of connective tissue disease (CTD) reagents to help improve diagnosis of this debilitating disease. 

Michael Mahler, Vice President, Research and Development at Inova Diagnostics, commented, “We have always been intrigued by the SeroTag® technology and have monitored its continuous progress over the last few years. We believe that there are many areas within autoimmunity that would benefit from additional biomarkers to close the diagnostic gap. Anti-BICD2, the novel marker from Protagen, provides the means to help fill that gap in SSc. The addition of anti-BICD2 to our CTD offerings may increase the overall accuracy of diagnosis, and may ultimately add to the understanding of the etiology of this disease.”

Stefan Müllner, Protagen CEO, adds, “This agreement is further confirmation of the high clinical and commercial value of our SeroTag® technology and its potential for continuous delivery of relevant, novel biomarkers. We are very proud that Inova Diagnostics has licensed BICD2 to complement its existing diagnostic assay portfolio, and look forward to further licensing deals. Furthermore, the liaison with the global market leader will guarantee fast market entry with a clear benefit for SSc patients.” 

About Systemic Sclerosis

SSc is a rare and highly heterogeneous autoimmune disease that can manifest as progressive fibrosis of the skin and internal organs. Depending on the extent of skin fibrosis, SSc is broadly divided into two subsets, diffuse cutaneous SSc (dcSSc) and limited cutaneous disease (lcSSc). However, this classification does not reflect the true clinical spectrum of the disease and some severe organ complications can occur across both groups. Autoantibodies which are present in more than 95% of SSc patients have been associated with organ involvement and disease outcome, and are essential tools for clinical management of SSc. 

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. 

For more information, please visit www.protagen.com

About Inova Diagnostics

Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in in vitro diagnostics (IVD) with a long term commitment to providing high quality, innovative solutions for hospitals and clinical laboratories to enhance patient care. Inova Diagnostics manufactures IVD systems and reagents for autoimmune disease that are used around the world, and is a leader in the development and commercialization of novel autoimmune technologies and diagnostic markers.