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Updated: Nov 26, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Molecular testing and targeted therapy for non-small cell lung cancer: Current status and perspectives
Evgeny N Imyanitov1, Aglaya G Iyevleva2, Evgeny V Levchenko3
1Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology, St.-Petersburg, 197758, Russia; Department of Medical Genetics, St.-Petersburg Pediatric Medical University, St.-Petersburg, 194100, Russia; Department of Oncology, I.I. Mechnikov North-Western Medical University, St.-Petersburg, 195067, Russia.
Abstract:
Molecular testing has become a mandatory component of the non-small cell lung cancer (NSCLC) management. The detection of EGFR, BRAF and MET mutations as well as the analysis of ALK, ROS1, RET and NTRK translocations have already been incorporated in the NSCLC diagnostic standards, and the inhibitors of these kinases are in routine clinical use. There are emerging biomarkers, e.g., KRAS G12C substitutions and HER2 activating alterations, which are likely to enter NSCLC guidelines upon the approval of the corresponding drugs. In addition to genetic examination, NSCLCs are usually subjected to the analysis of PD-L1 protein expression in order to direct the use of immune checkpoint inhibitors. Comprehensive NSCLC testing for multiple predictive markers requires the analysis of distinct biological molecules (DNA, RNA, proteins) and, therefore, the involvement of different analytical platforms (PCR, DNA sequencing, immunohistochemistry, FISH). There are ongoing efforts aimed at the integration of multiple NSCLC molecular assays into a single diagnostic pipeline.
Insights
Molecular testing is crucial for non-small cell lung cancer (NSCLC) management. Comprehensive analysis of genetic mutations and protein expression guides targeted therapies and immunotherapy for better patient outcomes.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genomics
Background:
- Molecular testing is integral to non-small cell lung cancer (NSCLC) management.
- Established biomarkers include EGFR, BRAF, MET mutations, and ALK, ROS1, RET, NTRK translocations.
- PD-L1 protein expression analysis is vital for guiding immune checkpoint inhibitor therapy.
Purpose of the Study:
- To review current molecular testing standards in NSCLC.
- To highlight emerging biomarkers like KRAS G12C and HER2 alterations.
- To discuss the integration of diverse molecular assays into a unified diagnostic pipeline.
Main Methods:
- Analysis of DNA, RNA, and proteins using various platforms.
- Inclusion of PCR, DNA sequencing, immunohistochemistry, and FISH.
- Focus on comprehensive biomarker detection for personalized NSCLC treatment.
Main Results:
- Current NSCLC diagnostics incorporate multiple genetic mutation and translocation analyses.
- Emerging biomarkers (KRAS G12C, HER2) are poised for inclusion in clinical guidelines.
- Integrated diagnostic pipelines are under development to streamline NSCLC molecular testing.
Conclusions:
- Standardized molecular testing, including genetic and protein markers, is essential for NSCLC treatment selection.
- The field is advancing with new biomarkers and integrated testing strategies.
- Future directions focus on consolidating multiple assays for efficient and comprehensive NSCLC profiling.
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