Product Development Pipeline
Due to the high diversity and overlapping of symptoms within different autoimmune diseases, achieving an accurate diagnosis and successful treatment strategy is very challenging. Complicating matters are the unpredictable periods of fluctuation between stable disease, progression and partial remission.
Autoantibodies - why use them?
Only about 30% of the antibodies circulating within the human body are directed against foreign pathogens. The vast majority are directed against the individual’s own proteins/antigens. These so called ‘autoantibodies’ have a number of intrinsic qualities that make them ideal as potential biomarkers for disease diagnosis and prognosis and today they are increasingly applied to the development of clinical diagnostic tests (Dx) to dramatically improve the management and treatment of autoimmune 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 and is a main area of focus for Protagen.
Powering the development of advanced diagnostics using SeroTag
The development of a diagnostic at Protagen begins with hPEX®, the world’s largest human antigen expression library. Through this biomarker library, we can detect more than 95% of the known, published disease-associated autoantigens and simultaneously analyze autoantibodies to over 7,000 human proteins in patient blood samples. All hPEX®proteins carry a His-tag for high-throughput purification, quality control, and ELISA plate immobilization, and all are sequence-verified by protein mass spectrometry.
Our SeroTag biomarker identification and development engine is a clinical quality, automated multiplex technology for the discovery and clinical validation of novel autoantigens at an unprecedented quality and pace. 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.
Building a clinical diagnostic portfolio
Protagen has discovered many novel biomarkers for indications across the spectrum of autoimmune diseases. All these markers undergo meticulous verification and validation studies within our internal discovery and development programs. The most suited markers then enter the ISO13485 certified development process for the development of in-vitro diagnostics (IVD).