Biomarkers and beyond: Companion diagnostics regulation - FDA's position
This article was originally published in Scrip
Executive Summary
The US FDA's Office of In Vitro Diagnostic Device Evaluation & Safety (OIVD) regards companion diagnostics as being at the heart of personalised medicine, maintaining that they carry the same risk profile as the drugs themselves. This means that proper use of the diagnostic is critical to the proper use of the drug and failure to use the drug properly based on test results is regarded as unsafe.