NEW YORK – The US Food and Drug Administration on Thursday said that it would recognize a part of Memorial Sloan Kettering Cancer Center's Oncology Knowledge Base, or OncoKB, in the FDA's Public Human Genetic Variant Databases, making it the first database of tumor mutations to be included in the resource.
As a result, a portion of MSK's OncoKB database — which contains information regarding alterations in 682 cancer genes curated from sources including government agencies, professional groups, scientific literature, and clinical trials — will be available for public use among test developers trying to validate their tumor profiling assays for premarket submission. The FDA has sorted the OncoKB data into two levels of clinical significance: Level 2, which refers to variants with clinical significance, and Level 3, which refers to variants with "potential" clinical significance.
The Human Genetic Variant Database program is designed to minimize the regulatory burden on diagnostic firms that comes with developing next-generation sequencing tests. Rather than having to independently prove the legitimacy of the database it uses to validate its individual test, firms can use the FDA-recognized database to support their test validation.
In 2018, the FDA recognized the Clinical Genome Resource consortium's ClinGen database as the first genetic variants repository, but until now, it has not done the same for any database of somatic mutations.