2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
FDA Comment Number : EC10
Submitter : Dr. Ronald Zimmern Date & Time: 11/21/2006 09:11:39
Organization : Public Health Genetics Unit
Category : International Organization
Issue Areas/Comments
The Public Health Genetics Unit is an organisation in the United Kingdom whose mission is to advance the responsible and effective translation of genome-based knowledge and technologies for the benefit of population health.

We wish to comment on the FDA's proposed guidance for in vitro diagnostic multivariate index arrays (IVDMIAs). We recognise that gene- and protein-based testing shows an increased potential for patient use and also potential for significant growth as an industry sector. We believe that it is vital for these tests to show not only analytic validity but also clinical validity and utility, in effect demonstrating that they are not just accurate and reliable, but also of clinical benefit. The problem as we perceive it is that there is as yet little consensus on the standards that should be required of clinical validity. We wish to point out that scientific demonstration of a validated link between a particular biomarker and disease is necessary but not sufficient for this purpose, and that in addition there needs to be some form of evaluation of the sensitivities, specificities, positive and negative predictive values of these biomarkers in the real world.

The question is whether this requirement should be statutory. We believe that there is a possibility that imposing a statutory regulatory framework on IVDMIAs may inappropriately hinder innovation and delay patient benefit. While statutory regulation has its benefits, we believe it should only be used in certain circumstances, such as when the safety of a product is at issue. We believe that guidance, such as that under consideration, should be sufficient to oversee IVDMIAs at their current stage of development.