Prevailing challenges in Companion diagnostic test development for lung cancer

PD-L1 and ALK are crucial predictive biomarkers for patients with NSCLC. PD-L1 IHC expression predicts response to immune checkpoint inhibitors (ICIs), but its predictive value is not perfect, with some PD-L1-negative patients benefiting from specific therapy. ALK IHC, with confirmatory FISH or NGS, guides tailored treatment. In this context, an integrated predictive approach enables the best clinical and therapeutic management of patients with NSCLC.