Protagen AG, Dortmund, Germany, and Inova Diagnostics, San Diego, have signed a semiexclusive licensing 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. 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 SSc (lcSSc). However, these classifications do not reflect the full clinical spectrum of the disease, and some severe organ complications can occur across both groups. Autoantibodies that 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.

Beyond such classical markers of SSc as anti-centromere antibodies and anti-Scl70 antibodies, anti-BICD2 antibodies are most abundant in SSc patients. The licensing agreement will permit Inova Diagnostics to add the novel biomarker to its portfolio of connective tissue disease (CTD) reagents to help improve diagnosis of the debilitating disease.

“We have always been intrigued by the SeroTag technology and have monitored its continuous progress over the last few years,” says Michael Mahler, vice president of research and development at Inova Diagnostics. “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,” Mahler adds. “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.

Stefan Müllner, Protagen.

“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,” says Stefan Müllner, Protagen CEO. “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.”

For more information, visit Inova Diagnostics or Protagen.