Diagnostic Platform

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.

SeroTag; Biomarker Development Engine

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Biomarker Discovery

Within our own R&D programs, we have successfully performed a broad range of proof of concept studies using disease specific biomarker panels for Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Systemic Sclerosis, Multiple Sclerosis and Neuromyelitis Optica.