NavigAID SSc is a new disease stratification array designed to support pharmaceutical and biotechnology companies with their Systemic Sclerosis (SSc) drug development efforts by defining specific disease subgroups via the simple measurement of serum biomarkers. NavigAID SSc has been developed using Protagen’s SeroTag® proprietary platform, which helps to understand complex autoimmune diseases on a molecular basis.
Protagen’s NavigAID SSc facilitates differential diagnosis, risk stratification and prediction of organ involvement to support the development of personalized therapeutics in SSc. Taking a unique disease stratification approach, NavigAID SSc is set to benefit any new SSc clinical development program. Furthermore, it has the potential to provide the basis for the development of treatment-specific companion diagnostics (CDx).
SSc is a rare, complex autoimmune disease that manifests as progressive fibrosis of the skin and internal organs. Unfortunately, and despite numerous efforts in recent years, no drug has been approved to date for the treatment of SSc, with the disease’s remarkably heterogeneous nature being the main hurdle for successful SSc drug development.
Depending on the extent and severity of skin thickness and fibrosis, SSc is broadly classified into two subsets, namely diffuse cutaneous SSc (dcSSc) and limited cutaneous SSc (lcSSc). However, this classification does not reflect the entire clinical spectrum of the disease and there are patients who exhibit characteristic SSc symptoms and still do not fall under either of these subsets.
Addressing the SSc heterogeneity challenge is pivotal for the clinical development of effective and curative therapies. Although significant progress has been made in understanding molecular disease mechanisms, there is still an unmet need for novel diagnostic biomarkers and assays for precise disease characterization, patient stratification and therapy response prediction.
Autoantibodies, which have been found to be stable and consistent within SSc patients over time, have been strongly associated with patterns of organ involvement and disease outcomes. As such, understanding their mechanisms of action is essential to the clinical management of SSc. The Protagen NavigAID SSc has been specifically developed to tackle the heterogeneity challenge associated with SSc and facilitate the clinical development of novel drug therapies by employing known as well as new proprietary molecular serum biomarkers.