OBJECTIVES: Historically, no specific biomarker testing was required to initiate therapy for NSCLC. In 2011, first recommendation was issued by ASCO advocating routine testing of the EGFR mutations in the management of NSCLC. Since then the treatment has become more personalized, targeted and biomarker-driven. Currently, the guidelines recommend testing in patients with NSCLC in the U.S., however, there are several associated challenges.

METHODS: We searched Medline (via Ovid) on January 08, 2020 to identify potential studies. Relevant keywords were identified and searched for the disease, biomarkers and challenges (limits applied: language – English, Year – limit 2011 – current, and Country – U.S.).

RESULTS: We identified 136 articles, among which 15 were included for the final analysis. Most of the biomarker testing rely on tissue samples rather than noninvasive plasma-based genotyping. This is primarily because of suboptimal sensitivity/specificity in noninvasive methods. Tissue sampling appeared to be promising surrogate, however, the past decade highlighted certain associated challenges. Firstly, the tumor location led to difficulties for the radiologist to perform the biopsy. Secondly, biopsies are painful for patients and are associated with continuous sampling requirement for monitoring the treatment effect, thus making them furthermore non-feasible. The long turnaround time also poses a big challenge. Economical challenges comprise of personnel training and technical infrastructure. Lastly, the private payer coverage of biomarker testing is another challenge, although, in 2018, there has been an effort to overcome these challenges with the approval of a national coverage decision for Next-Generation Sequencing (NGS) testing by the U.S. Centers for Medicare and Medicaid Services.

CONCLUSIONS: Over the last decade biomarker testing has become essential for determining the optimal treatment, but the testing presents clinical and logistical challenges. The advent of NGS has made a tremendous impact by testing multiple genetic markers at once which is reducing the cost and need of rebiopsies.