USA – FDA recognizes Memorial Sloan Kettering tumor variant database

The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.

A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. In April 2018, the agency finalized a guidance document that sets a roadmap for how developers of genetic and genomic-base in vitro diagnostics (IVDs) can use public databases of human genetic variants in support of clinical validity claims…