Biomarker qualification can be a first step towards companion diagnostic development. The European Medicines Agency already has a biomarker qualification process and the US Food and Drug Administration is developing one itself. The two agencies should find a way to harmonise their respective processes and propose clear incentives for companies seeking to use them.
Sabah, Malek, Sylvie Le Glédic, Anne Dupraz-Poiseau
Biomarkers qualifications : a first step towards companion diagnostic development
2011 – SCRIP Regulatory Affairs