ROS1 and ALK Testing

Prior to selection of first-line systemic therapy, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend molecular testing in all patients with metastatic nonsquamous NSCLC1*
  • Molecular testing should be conducted as part of broad molecular profiling that includes ROS1, ALK (Category 1), EGFR (Category 1), and BRAF*
*The NCCN Guidelines® for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays.1
Test for ROS1 and ALK to inform initial treatment decisions
In the US, ALK gene fusion occurs in 3% to 5% of patients with NSCLC, while incidence of ROS1 is estimated at 1% to 2%.2,3 ALK and ROS1 are most commonly associated with adenocarcinoma histology. However, ALK and ROS1 have been seen in squamous cell carcinomas and, in some cases, adenosquamous carcinomas.4-6
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed February 12, 2020. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  2. Garber K. ALK, lung cancer, and personalised therapy: portent of the future? J Natl Cancer Inst. 2010;102(10):672-675.
  3. Gainor JF, Shaw AT. Novel targets in non-small cell lung cancer: ROS1 and RET fusions. Oncologist. 2013;18(7):865-875.
  4. Bergethon K, Shaw AT, Ou SH, et al. ROS1 rearrangements define a unique molecular class of lung cancers. J Clin Oncol. 2012;30(8):863-870.
  5. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for 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. J Mol Diagn. 2018;20(2):129-159.
  6. Cai W, Li X, Su C, et al. ROS1 fusions in Chinese patients with non-small-cell lung cancer. Ann Oncol. 2013;24(7):1822-1827.
  7. Ion Torrent™ Oncomine™ Dx Target Test user guide. Waltham, MA: Thermo Fisher Scientific Inc.; 2017.
  8. Vysis ALK Break Apart FISH Probe Kit [package insert]. Des Plaines, IL: Abbott Molecular Inc.; 2015.
  9. VENTANA ALK (D5F3) CDx Assay [package insert]. Tucson, AZ: Ventana Medical Systems, Inc.; 2017.
  10. FoundationOne CDx™ (F1CDx™) diagnostic device [package insert]. Foundation Medicine, Inc.; 2017.
  11. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(suppl 5):e142S-e165S.