ABSTRACT
Regulatory pathways for companion diagnostics have developed in close association with the identification through genetic testing of enrichment biomarkers for selection of specific patient subpopulations. There are two unique pathways for the regulatory qualification and approval of biomarkers at the food and drug administration (FDA): the biomarker qualification pathway at the center for drug evaluation and research and the companion diagnostic approval at the center for devices and radiological health. The FDA Pharmacogenomics guidance suggested in 2005 the need for a second document that would cover companion diagnostics. The path from an exploratory biomarker to a biomarker qualified for a specific application context can be long and unpredictable. The development of the new renal toxicity biomarkers was led by the predictive safety testing consortium, whose members include scientists from over a dozen pharmaceutical companies. Biomarkers can be considered tools to be qualified in close association with individual submissions for drug approvals.
