On October 7, 2021, the Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.
FDA recognized a portion of the OncoKB as a source of valid scientific evidence for Level 2 (clinical significance) and Level 3 (potential clinical significance) biomarkers. Under the FDA’s database recognition program, test developers can use these data to support the clinical validity of tumor profiling tests in premarket submissions.
Determining the mutation profile of a tumor using DNA sequencing enables the use of targeted therapies and investigational treatment options.
The OncoKB database contains detailed information regarding specific alterations in 682 cancer genes. The information is curated from various world-wide sources, including government agencies, medical professional groups, medical and scientific literature, and clinical trials.
FDA reviewed the operating and governance procedures and policies, processes for the database and for variant evaluation and curation, and method of assignment of clinical significance. The data are sorted into one of two levels of clinical significance consistent with FDA-authorized tumor profiling tests and displayed on a tab referred to as “FDA recognized alterations.”