ARTICLE | Politics & Policy

FNIH releases final biomarker framework

December 8, 2016 12:05 AM UTC

The Foundation for the National Institutes of Health (FNIH) released its framework outlining basic evidence required for biomarker qualification. The framework is designed to provide predictable and specific regulatory criteria, and was produced through collaboration among FNIH, FDA, NIH, the Critical Path Institute (C-Path), PhRMA and industry stakeholders.

The framework outlines a process for developers to describe the clinical need for a biomarker and context for its use, along with its potential risks and benefits, in order to determine evidentiary criteria required for validation. It outlines expectations for assay validation, knowledge of molecular mechanisms that underlie biomarker performance, and biomarker specificity that can be used as evidentiary criteria. The framework also encourages flexibility in adjusting biomarker use as its supporting data matures...