Process map proposal for the validation of genomic biomarkers
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Updated: Aug 6, 2026
Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
Published on: June 21, 2018
Federico Goodsaid1, Felix Frueh
1US Food and Drug Administration, Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 21, Room 3663, Silver Spring, MD 20903-0002, USA. Federico.Goodsaid@fda.hhs.gozv
Abstract:
How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process.
