Biomarker Testing rates Rise in NSCLC, But NGS Gaps remain
Published: 2026/01/14 02:44:12
Non-small cell lung cancer (NSCLC) treatment is becoming increasingly personalized, with biomarker testing playing a pivotal role in guiding therapeutic decisions. A recent examination offers reassuring data regarding biomarker testing rates in patients treated at academically-affiliated community clinics, but also highlights a notable gap in access to next-generation sequencing (NGS). The study, published in JCO Oncology Practice, found that the vast majority of patients receive testing for key biomarkers, yet nearly half do not benefit from the more thorough analysis offered by NGS.
Guideline-Concordant Testing: A positive Trend
The research, led by Kenneth L. kehl, MD, MPH, assistant professor of medicine at Harvard medical School and associate director of clinical research at Dana-farber Cancer Institute, evaluated 525 patients with advanced NSCLC. The findings demonstrate that over 85% of patients received testing for common biomarkers including EGFR,ALK,and PD-L1 – aligning with established clinical guidelines. This indicates a strong commitment to guideline-concordant care within these community-based settings.
“These findings reinforce the high quality of care provided by our colleagues in academically-affiliated community practice settings, as well as the importance of guideline-concordant biomarker testing for advanced NSCLC, especially in the periods just after initial FDA approval of a new agent,” Kehl told Healio.
This high rate of testing for established biomarkers is crucial, as it allows clinicians to identify patients who are likely to benefit from targeted therapies. For example, identifying an EGFR mutation allows for the use of EGFR-tyrosine kinase inhibitors (TKIs), while an ALK rearrangement indicates a potential benefit from ALK TKIs.
The NGS Gap: A Critical Area for Enhancement
Despite the positive trends in guideline-concordant testing, the study revealed a significant gap in NGS utilization.Approximately 45% of patients did not receive NGS during the study period. This is concerning, as NGS offers a more comprehensive analysis of a patient’s tumor, identifying a wider range of potential therapeutic targets.
NGS allows for the detection of less common, but potentially actionable, mutations that may not be identified through standard biomarker testing. This is particularly important as the landscape of targeted therapies continues to evolve, with new drugs being developed to address increasingly specific genetic alterations.
The study showed that NGS utilization increased substantially over the study period (2018-2021), rising from 14% to 61%.This suggests a growing awareness of the benefits of NGS and increasing access to this technology. However, the remaining gap highlights the need for continued efforts to improve access and utilization.
Why is Biomarker Testing So Critically important?
Biomarker testing has become “increasingly critical” in NSCLC management over the past two decades. The identification of specific biomarkers allows for a more personalized approach to treatment,maximizing the likelihood of a positive response and improving patient outcomes.
according to the National Comprehensive Cancer Network (NCCN) guidelines, biomarker testing is essential for all patients with advanced NSCLC. The NCCN guidelines are regularly updated to reflect the latest advances in the field, and they serve as a valuable resource for clinicians seeking to provide the best possible care for their patients.
Researchers have identified over 10 biomarkers that can inform treatment decisions, including:
* EGFR: Epidermal growth factor receptor
* ALK: Anaplastic lymphoma kinase
* ROS1: ROS proto-oncogene 1, receptor tyrosine kinase
* BRAF: B-Raf proto-oncogene, serine/threonine kinase
* KRAS: Kirsten rat sarcoma viral oncogene homolog
* MET: MET proto-oncogene, receptor tyrosine kinase
* RET: Rearranged during transfection
* NTRK: Neurotrophic tyrosine receptor kinase
Implications for Clinical Practice
The findings of this study have critically important implications for clinical practice. Clinicians should prioritize guideline-concordant biomarker testing for all patients with advanced NSCLC, including NGS whenever feasible.
Kehl emphasizes the importance of establishing “close collaborative workflows with pathologists and testing vendors to accomplish this.” This collaboration is essential to ensure that patients have access to the most appropriate testing and that results are interpreted accurately and efficiently.
Furthermore, ongoing efforts are needed to address the barriers to NGS access, such as cost, turnaround time, and lack of expertise. As NGS technology becomes more affordable and accessible, it is indeed likely to become an increasingly integral part of NSCLC management.
Future Directions
Looking ahead, Kehl suggests that future research should focus on:
* diffusion of novel biomarker testing: Ensuring that new biomarkers are rapidly and effectively integrated into clinical practice.
* Early-stage NSCLC testing: Expanding biomarker testing to earlier stages of the disease, where it can inform adjuvant and neoadjuvant treatment decisions.
* Optimizing NGS utilization: Identifying strategies to improve the uptake of NGS and ensure that patients receive the most comprehensive genomic profiling possible.
Ultimately, the goal is to provide all patients with NSCLC with access to the personalized treatment they deserve, based on the unique characteristics of their tumor. Continued research and collaboration will be essential to achieving this goal.
Source: Farhat K, et al. JCO Oncol Pract. 2025;doi:10.1200/OP-25-00280.
