Acquiring high-quality biomarker data is paramount when it comes to drug development and clinical trials. Precise biomarker data streamlines the research and development process, significantly reducing the time and cost of bringing new diagnostic tests and drugs to market. It allows for more focused clinical trials, minimizing the risk of late-stage failures and ensuring resources are used efficiently.
Sengenics is an industry leader in developing cutting-edge, high-throughput tools for accurate autoantibody (AAb) biomarker discovery and validation from just a drop of blood. Over the past four years, Sengenics’ innovative tools have been utilized by the world’s leading pharmaceutical companies and academic institutions. Their advanced technology has helped expand the potential of AAb biomarkers beyond autoimmune diseases to a broader spectrum of diseases, including cancer, neurological disorders, and infectious diseases.
Dr. Jonathan Blackburn, Founder and Chief Scientific Officer at Sengenics, highlights some of the reasons why AAbs are excellent clinical biomarkers, “Antibody levels in serum remain stable over time, typically unaffected by common stimuli like diet or exercise. They change primarily in response to disease or treatment, often years before clinical diagnosis.”
Guiding Drug Development and Clinical Trials
Sengenics technology is being leveraged by the pharmaceutical industry to pinpoint targetable antigens and pathways, alongside pathogenic and protective antibodies. These insights can be used to repurpose drugs, develop vaccines and therapies, and predict immune-related adverse events. They can also facilitate early disease detection, disease subtyping, and disease monitoring.
Antibody levels in serum remain stable over time, typically unaffected by common stimuli like diet or exercise. They change primarily in response to disease or treatment, often years before clinical diagnosis.
Dr. Blackburn elaborates on the technology’s application in industry, stating, “Data obtained with the Sengenics platform are helping to select patients for phase I/II clinical trials. Autoantibodies are also being explored as quantitative, surrogate biomarkers for clinical response, with the goal of shortening clinical trials and thereby significantly reducing costs.”
Generating Biologically Relevant Data
Sengenics KREX® technology overcomes challenges with traditional antibody profiling methods. Traditional methods use peptides, protein fragments, or improperly folded proteins, often resulting in nonspecific antibody-antigen binding, false positives, and high background.
Sengenics technology ensures that only correctly folded, full-length, and functional proteins are displayed for AAb binding. Its high-density protein microarrays boast picomolar (pM) sensitivity, a 5-log linear dynamic range, and high reproducibility [i.e., mean intra-array coefficient of variation (CV) < 10%]. 
