While the intended audience for OncoKB™ is primarily clinical oncologists, molecular pathologists and cancer researchers, tumor profiling next generation sequencing (NGS) test developers may also rely on human variant databases, such as OncoKB™, for variant information to support the clinical validity of their tests. Therefore, to credential the robustness and transparency of databases involved in variant evaluation, the FDA introduced a process to recognize human variant databases.

Below is the FDA-recognized content in OncoKB™, including tumor type-specific alterations and their corresponding FDA fact sheet. The assigned FDA level of evidence is based on these alterations being tested in Formalin Fixed Paraffin Embedded (FFPE) specimen types, except in cases where specimen type is not specified.

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