Bridging the gap: Multi-stakeholder perspectives of molecular diagnostics in oncology.

Abstract

Molecular diagnostics has revolutionized cancer management, enabling the identification of diagnostic, prognostic, and predictive biomarkers. Despite advancements in technologies such as whole genome sequencing, their translation into clinical practice remains challenging due to insufficiently demonstrated clinical utility. This study identifies unmet clinical needs and requirements for innovative molecular technologies in oncology through interviews (n = 22) and an online survey (n = 116), gathering insights from hospital professionals, industry representatives, and health policy and quality assessment experts. Our findings emphasize the increasing importance of liquid biopsies (LBx), particularly plasma-based assays. Key unmet needs in this area include therapy response monitoring, minimal residual disease detection, and predictive biomarker testing. Additionally, we outline technology requirements tailored to diverse clinical biomarker applications and both centralized and decentralized laboratory settings. A central challenge lies in achieving an optimal balance between multiplexing capacity and turnaround time. By bridging the gap between technology development and real-world application, this study paves the way for the implementation of new molecular technologies that better meet the needs of the oncology community, ensuring clinical utility and ultimately improving patient care.