Standardization of Molecular Diagnostic Testing for Non-small Cell Lung Cancer

Recent studies have identified specific genetic mutations that reliably predicttherapeutic success with targeted treatment regimens in many forms of cancer, and particularly in non-small cell lung cancer (NSCLC). Importantly, patients with oncogenic driver mutations have better tumor control with targeted agents than with chemotherapy, while those lacking such mutations derive more benefit from chemotherapy (Mok et al. New Eng J Med, 361:94, 2009). To detect actionable mutations all patients with metastatic disease must be tested. Mutation assaysare generally performed using tissues derived from surgical samples. However, for most patients with metastatic NSCLC the only tissue available is from fine needle aspirates (FNAs). The American Society of Clinical Oncology (ASCO) (Leighl et al. J Clin Oncol 32:3673-3679, 2014) recently endorsed an evidence-based guideline recommending standardized testing for two commonly observed oncogenic drivers in advanced lung cancer. Even so, the authors noted that during the review, new targetable genetic alterations had been identified, and cited a challenge in performing multiple sequential assays for each mutation, given the limited tumor tissue available. The user, Eastern Ontario Regional Laboratories Association (EORLA) has identified the potential for a multiplexed diagnostic test for oncogenic drivers from NSCLC fine needle aspirates and liquid biopsies to address this need.