Review of the Role of Biostatistics in the Life Cycle of Commercial Molecular Diagnostic Assays

New therapies may be most effective for individuals with specific genetic variants. Today, many early phase trials are enriched such that subjects with the variant are enrolled and those that do not harbor the variant may not be eligible for enrollment. For these trials, companion diagnostic (CDx) assays using molecular biomarkers to measure features of DNA and RNA may be tested in parallel (or after drug release) for the purpose of indicating which populations may most likely respond to disease treatment, or are less likely to suffer side-effects of biomarkers.

Download our latest article to learn how and when biostatisticians are involved, what specialized information they provide, and how they can help maximize the chances of success while minimizing risk and cost.