The Role Of The Global Central Laboratory In Successful CDx Development

Since the approval of the first companion diagnostic (CDx), HER2, in 1998, precision medicine has embraced companion diagnostics as one way to ensure that targeted therapies can be appropriately administered to the right patient with some degree of assurance following clinical validity within clinical trials.

The clinical validity of the companion diagnostic tends to be the final piece before the assay is submitted for PMA in the US. Long before that, translational science investigations sought to determine which biomarkers might be used for patient selection in the context of safety and/or efficacy. For these biomarkers, they have tended to fall into four main technology categories: Immuno-histochemistry (IHC), fluorescent in situ hybridisation (FISH), molecular via PCR and next generation sequencing (NGS). Although more recently, flow cytometry and immunoassay approaches are being considered for CDx.