Identification of specific biomarkers in lung cancer cells allows differentiation between tumour types and provides predictive and prognostic information.

Various international and national expert guidelines on biomarker testing in lung cancer recommend the majority of patients with lung cancer should be tested. Testing may include detecting:1-6

  • Epidermal growth factor receptor (EGFR) gene mutations
  • Anaplastic lymphoma kinase (ALK) gene fusions
  • ROS proto-oncogene 1 (ROS1) gene rearrangements
  • B-Raf proto-oncogene (BRAF) gene mutations
  • Programmed cell death ligand-1 (PD-L1) protein expression



Approximately a quarter of non-small cell lung cancer (NSCLC) tumours have an actionable driver oncogene mutation in either the EGFR, ALK, ROS1 or BRAF genes, which are associated with an approved oral targeted therapy.7Further, up to two-thirds of advanced/metastatic NSCLC tumours have PD-L1 expression above clinically meaningful cut-offs that are linked with a favourable response to immunotherapy.8, 9

Lung Cancer

The biomarkers listed above, including what they are and how they are tested, are discussed in more detail in the Biomarker Testing in Lung Cancer page.

Testing in NSCLC

Performing robust, reliable,high-quality biomarker testing is key to making informed treatment decisions for patients. Further details on the technical considerations of biomarker testing in NSCLC can be found here.


Once a patient has been diagnosed with lung cancer, it is important that they receive adequate information and support about their diagnosis. Additional resources can be found on the Patient Communication page.

  1. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med 2018;142:321–346
  2. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2018;29:iv192–iv237
  3. NCCN. Clinical Practice Guidelines in Oncology Non-Small Cell Lung Cancer Version 3.2020. 2020. Available from: 11 June 2020
  4. Garrido P, Conde E, de Castro J, et al. Updated guidelines for predictive biomarker testing in advanced non-small-cell lung cancer: a national consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology. Clin Transl Oncol 2019;[Online ahead of print]
  5. Hanna N, Johnson D, Temin S, et al. Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2017;35:3484–3515
  1. Pennell NA, Arcila ME, Gandara DR, et al. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book 2019;39:531–542
  2. VanderLaan PA, Rangachari D, Majid A, et al. Tumor biomarker testing in non-small-cell lung cancer: A decade of change. Lung Cancer 2018;116:90–95
  3. Aggarwal C, Abreu DR, Felip E, et al. Prevalence of PD-L1 expression in patients with non-small cell lung cancer screened for enrollment in KEYNOTE-001, -010, and -024. Ann Oncol 2016;27(supplement 6):vi359–vi378
  4. Mok TSK, Wu Y-L, Kudaba I, et al. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet 2019;393:1819–1830