The Food and Drug Administration (FDA) announces a workshop titled "Weighing the Evidence – Variant Classification and Interpretation in Precision Oncology".
The goal of precision oncology is to use a cancer patient’s genetic data to help determine which therapeutic(s) might be most effective in treating their disease. Next generation sequencing is increasingly employed in oncology because the technology can be used to screen for a large number of mutations simultaneously to optimize and personalize patient care. The increasing number of reported mutations may lead to uncertainty for clinicians in the interpretation and prioritization of the variants with respect to the clinical significance and optimal course of action, respectively.
FDA is holding this public workshop to engage stakeholders and solicit input from experts in precision oncology to discuss how genetic sequencing data is best implemented in patient management so that innovative regulatory strategies can be advanced to support the development of safe and effective precision-based drugs and devices for marketing.
Members of the public may attend in person or via webcast. More information is available at the FDA website.