Product Development Pipeline
Due to the high diversity and overlapping symptoms within different autoimmune diseases, achieving an accurate diagnosis and successful treatment strategy is very challenging. Protagen’s pipeline of novel biomarkers and diagnostic tests are aimed at providing more specific diagnoses for each disease indication and enables patient subgrouping for more targeted therapeutic development.
Autoantibodies as accurate indicators of disease
Only about 30% of the antibodies circulating within the human body are directed against foreign pathogens. The vast majority are autoantibodies and directed against the individual’s own proteins/antigens. Providing a number of intrinsic qualities, autoantibodies are ideal as potential biomarkers for disease diagnosis and prognosis. Today they are increasingly applied to the development of clinical diagnostic tests (Dx) to dramatically improve the management and treatment of disease over a patient’s lifetime.
It is the discovery of novel biomarkers and multi-marker disease-specific panels which hold the promise of providing more accurate diagnostics for disease identification and profiling. Protagen’s library of autoantibody signatures from more than 17,000 patient samples spanning numerous therapeutic areas and indications provides insight and a strong foundation for its discovery and development efforts.
Powering the development of advanced diagnostics
Using this powerful library, as part of the SeroTag® biomarker identification and development engine, Protagen can detect more than 95% of the known, published disease-associated autoantigens and simultaneously analyze autoantibodies to over 8,000 human proteins in patient blood samples.
Protagen’s SeroTag® platform encompasses a clinical quality, automated multiplex technology for the discovery and clinical validation of novel autoantigens. By utilizing the FDA-approved bead-based Luminex® xMAP technology, SeroTag® allows for the high-throughput de-novo discovery of biomarker candidates by measuring the levels of autoantibodies to thousands of different antigens in every single serum sample from thousands of patients.
What results is a number of novel, proprietary biomarker candidates that demonstrate specificity for certain diseases or disease subgroups which can then be placed into development and validation as an in-vitro diagnostic (IVD) product, a patient stratification tool (via Protagen’s portfolio of NavigAID products) or a biomarker for licensing to development partners.
With a focus on autoimmune disease and immuno-oncology, Protagen is well positioned to support the clinical diagnostic and drug development markets.