Abstract

Molecular tumor profiling for patients with advanced or recurrent solid tumors is increasingly adopted as standard of care in oncology, as it has been demonstrated that improved clinical outcomes can result from selection of the optimal therapy for individual patients.

The Clinical Utility of a molecular profiling approach must demonstrate whether they lead to a reconsideration of the treatment plan and whether this improves the clinical outcome in profiled patients. Our comparison of 4 commercially available molecular profiling services and those of purely academic approaches, revealed a wide range of impact on treatment choice and clinical benefit. These variations in profiling service performance highlight the need for ongoing justification, quality control and evaluation if this methodology is to be effectively deployed within the clinical setting. It also means that a profiling approach without clinical outcome data can only be considered to perform in line with the lowest performing comparator in terms of clinical utility and cost effectiveness until otherwise demonstrated.