Validation - delivering value to discoveries
In biomarker discovery, it is necessary to validate both the clinical assay and the analytical methods to ensure that the measurement of the biomarker(s) is reliable and accurate. The OCBN devotes significant energy and resources to validation research since it is a critical step in the production of a useful clinical tool. Our members have significant expertise in the evaluation of accuracy, precision, reproducibility, and performance characteristics of tests, including sensitivity, specificity, and positive and negative predictive values.
Validation typically requires large sample sizes and high-throughput assays. Biomarkers should ideally be validated in prospective, well-controlled clinical trials with well-established standards for every aspect of the research process including, tissue collection, sample preparation, analytical method(s), data capture, and statistical analysis. OCBN’s active involvement in methodological research ensures that its research standards have been demonstrated to produce the most reliable results based on the most current empirical evidence.