Posted by Michael Wonder on 07 Oct 2021
FDA recognises Memorial Sloan-Kettering database of molecular tumour marker information
7 October 2021 - Today, the FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumour mutation database to be included in the Public Human Genetic Variant Databases.
FDA recognised 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 tumour profiling tests in premarket submissions.
