Protagen is uniquely positioned to synergistically combine the largest global human protein libraries with high-throughput identification of disease and treatment markers in patient samples (SeroTag to develop diagnostics and companion diagnostics).
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. With the need for better diagnosis in mind, we have developed the most comprehensive and powerful screening platform currently available to profile patients´ immune response. Subsequently diagnostic (Dx) and companion diagnostic (CDx) tests are developed. Our proprietary platform utilizes hPEX®, the world’s largest human antigen library, and SeroTag the unique biomarker development engine. By that means we can detect more than 95% of the known autoantibodies and simultaneously analyze autoantibodies to over 7,000 human proteins in patient blood samples.
Autoantibodies - why use them?
Only about 30% of the antibodies circulating within the human body are directed against foreign pathogens such as viruses and bacteria. 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.
- autoantibody presence is discernable at the earliest stages of disease
- autoantibody profiles follow the progression of disease and are indicative of disease status
- autoantibodies great abundance and stability in patient serum, plasma, or cerebrospinal fluid enhance analytical sensitivity
- autoantibody measurement is routinely established in the majority of hospitals and clinical laboratories
- autoantibody concentrations are unaffected by circadian rhythm or acute, short-term changes in physiological states
Powering the development of advanced diagnostics using SeroTag
The identification of autoantibodies in autoimmune diseases and their subsequent use in clinical diagnostic tests has dramatically improved the management and treatment of autoimmune diseases. Ultimately, novel Dx and CDx will significantly contribute to better, cost efficient patient management.
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.
Enabling Patient Stratification using SeroTag
SeroTag can be used to support clinical drug development programs (Phases I-IV) in autoimmune disease through the development of accurate and sensitive diagnostic assays (Dx) and companion diagnostic tests (CDx). These tests aid the specific diagnosis of autoimmune disease and enable the stratification of patients and diseases, ultimately leading to improved therapeutic regimens.
Our ISO-certified processes are established, robust and reliable. SeroTag has been successfully used to determine autoantibody signatures in more than 8,000 patients suffering from autoimmune diseases including Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Systemic Sclerosis, Multiple Sclerosis and Neuromyelitis Optica.
SeroTag for drug and CDx development
Our SeroTag biomarker identification and development engine can be systematically employed to support clinical drug development programs (Phase I-IV), and to develop novel CDx by offering:
- Accurate disease definition, e.g. during patient screening
- Identification of responder and/or non-responder sub-populations
- Analysis of disease progression and/or treatment effects
The application of SeroTag during the clinical development process of autoimmune disease drugs will lead to a reduction in clinical development costs, increased success rates and faster regulatory approval. In addition, it will facilitate more efficient and effective reimbursement discussions with Health Care Funding bodies.
Protagen is actively collaborating with a number of Pharma and Biotech companies to support clinical development programs with innovative autoantibody based biomarker programs. If you’d like to develop sensitive diagnostics that accurately reveal patient disease state and likely response to therapy, then please do get in touch - we’d be delighted to help.