Biomarker Profiling is Integral to Lung Cancer Characterization1,2

While many genetic alterations have been identified, knowing the presence of predictive biomarkers may lead to favorable patient outcomes1,2

Approximately 64% of patients with NSCLC have oncogenic driver mutations3

The National Comprehensive Cancer Network® (NCCN®) advises to consider testing for the indicated biomarkers1

AKT1=AKR mouse thymoma kinase; ALK=anaplastic lymphoma kinase; BRAF=v-raf murine sarcoma viral oncogene homolog B1; DDR2=discoidin domain receptor 2; EGFR=epidermal growth factor receptor; FGFR1=fibroblast growth factor receptor 1; HER2=human epidermal growth factor receptor 2; KRAS=Kirsten rat sarcoma 2 viral oncogene homolog; MEK1=mitogen-activated protein kinase kinase 1; MET=met proto-oncogene; NRAS=neuroblastoma rat; PIK3CA=phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha; PD-L1=programmed death-ligand 1; PTEN=phosphatase and tensin homolog; RET=rearranged during transfection; ROS1=ROS proto-oncogene 1.

National Comprehensive Cancer Network® (NCCN®) and CAP/IASLC/AMP recommendations

NCCN Guidelines® for NSCLC recommend biomarker testing to identify driver mutations for which appropriate targeted therapy may be available1:

  • Test for EGFR mutations and ALK rearrangements (category 1 for metastatic non-squamous NSCLC or NSCLC NOS), which are similar to the 2017 CAP/IASLC/AMP recommendations1,4,5
  • Test for ROS1* rearrangements and BRAF* mutations for non-squamous NSCLC or NSCLC NOS1
  • Test for PD-L1 expression (category 1) and NTRK* gene fusions in patients with metastatic NSCLC1

*Recommendations are category 2A unless otherwise specified.1
The 2017 CAP/IASLC/AMP guidelines do not recommend testing for these genes as standalone assays. Appropriate validation of any sample prep and testing methodology is critical. The NCCN Guidelines also strongly advise broader molecular profiling to identify rare driver mutations.1,4
FDA=US Food and Drug Administration; NGS=next-generation sequencing; NOS=not otherwise specified; PCR=polymerase chain reaction.





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