The Current State of Companion Diagnostics In Oncology: A Strategy Review

Oncology clinical development programs are now typically using patient selection strategies to identify likely responders/non responders for efficacy and/or safety outcomes. Solid tumor lymphoma and leukemia indications increasingly have biomarker analysis built into their clinical development plans, and many of those biomarker plans include the provision for a companion diagnostic assay.

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.

However, before a companion diagnostic can be delivered as an approved tool for patient care, it requires a vigorous level of analytical validation and testing within clinical trials before submission to the regulatory authorities, typically alongside the companion therapeutic.