Challenges in the clinical implementation of precision medicine companion diagnostics

Abstract

Introduction: The pace of biomarker discovery has increased exponentially over the last few years, ushering in an era of precision medicine (PM) with a growing arsenal of treatments tailored to specific patient populations. To accurately identify patients, companion diagnostics (CDx) are developed and launched alongside these treatments. However, even with a timely launch of therapies and CDx tests, patients are not guaranteed optimal access to these tests because of the inefficiencies embedded within the clinical diagnostic testing landscape supporting PM.

Areas covered: This commentary describes implementation challenges facing CDx tests and delaying clinical uptake. We also assess the 'siloed thinking' perpetuating these challenges and propose steps toward resolution. Our research is based on published literature and findings from the Diaceutics proprietary patient testing database.

Expert opinion: The clinical and economic ecosystem underpinning the diagnostic journey of patients remains severely underdeveloped. Patients are denied suitable therapies because of delayed identification or failings in real-world testing deployment. Progress is needed in clinical collaborations, integrator platforms, economic value sharing, and ownership of the patient testing journey to PM. We need to consider that better precision testing will deliver an equal or greater outcome to patients than new precision treatments alone.

Keywords: Biomarker; companion diagnostic; diagnostic; harmonization; precision medicine; testing; testing ecosystem.