The most prevalent emerging biomarker in advanced non-small cell lung cancer (NSCLC)1–3

Targeting driver mutations enables personalized medicine.

KRAS mutations are common oncogenic drivers in NSCLC and generally exclusive of other driver mutations in genes such as EGFR, ALK, and ROS1.4 KRAS mutations are often early truncal mutations that can persist during disease progression.5

Although no KRAS-targeted therapies are approved for NSCLC, the KRAS G12C mutation is an emerging biomarker.

Prevalence of driver alterations in lung adenocarcinoma2

Detected in ~13% of NSCLC cases, KRAS G12C is nearly as frequent as all EGFR mutations combined.6

*Infrequent Alterations: ALK, BRAF, HER2, MEK1, NTRK1, PIK3CA, RET and ROS1

KRAS G12C is the single most prevalent emerging biomarker in NSCLC2

~1/8 patients

in the US with NSCLC have the KRAS G12C driver mutation5

Guidelines support testing KRAS as an emerging biomarker

Discovery of driver mutations through biomarker testing is key to creating personalized approaches to patient management. Upfront testing for KRAS mutations may be helpful in patients with advanced NSCLC.7 † ‡

KRAS Testing at Diagnosis

  • National Comprehensive Cancer Network® (NCCN®)

Expanded panel testing may be useful

  • CAP / IASLC / AMP and ASCO

Expanded panel recommended

  • † NCCN Clinical Practice Guidelines in Oncology (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.
  • ‡ Upfront testing for KRAS mutations may identify patients who are unlikely to benefit from further molecular testing because of the low probability of overlapping targetable alterations.

Biomarker testing reveals activated KRAS

KRAS is a membrane-associated GTPase that regulates cell proliferation and differentiation. KRAS G12C is a point mutation in codon 12 causing a glycine-to-cysteine substitution near a narrow pocket in the KRAS protein.8,9 Advances in understanding the protein structure have led to the investigation of inhibitors that target the pocket, potentially locking the KRAS G12C mutant protein in the inactive state.

KRAS G12C mutation drives oncogenic signaling10

The KRAS G12C mutation favors the active form of KRAS mutant protein.8

Biomarker Assist™ KRAS Single Gene Testing (SGT) Program

The Biomarker Assist™ KRAS SGT Program is an Amgen sponsored testing program through NeoGenomics Laboratories to provide a single gene biomarker test, KRAS G12C mutation analysis at no cost to patients living with advanced or metastatic (stage IV) non-small cell lung cancer. Eligible patients with receive access to one (1) KRAS Mutation Analysis by Sanger Sequencing. Please note the program does not cover any other costs, including, but not limited to, office visit fees and biopsy fees.

To enroll your patients in the KRAS SGT Program, please follow 3 simple steps:

Order the test and collect sample for a single gene biomarker test to detect KRAS G12C in advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC) patients
Send the completed KRAS SGT request form and the sample to NeoGenomics Laboratories (if sample is not sent, ensure Specimen Retrieval is completed on the form and fax to 1-239-690-4237)
Results will be delivered within 7 days of receipt of form and specimen that meets all requirements

If you have questions, please call NeoGenomics Client Services at 1(866)776-5907 option 3.

Download the form and see full terms and conditions.

For more information on Amgen's Biomarker Assist™ KRAS Single Gene Testing Program or Next Generation Sequencing (NGS) Affordability Program, please visit or call Amgen Assist 360™ at 1-888-4ASSIST (1-888-427-7478) for details.

Biomarker Assist™ is a registered trademark of Amgen Inc.

For more information on specimen requirements and other test details please visit: /test-menu


  1. Arbour KC, et al. Clin Cancer Research. 2018;24;334-340.
  2. Pakkala S, et al. JCI Insight. 2018;3 e120858.
  3. Graham RP, et al. Arch Path Lab Med. 2018 Feb ;142(2):163-167.
  4. Shea M, et al. Ther Adv Respir Dis. 2016;10:113-129.
  5. Villaflor V, et al. Oncotarget. 2016;7:66880-66891.
  6. Data on file, Amgen; 2020.
  7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer. V8.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 22, 2020. To view the most recent and complete version of the guideline, go online to
  8. Ryan MB, et al. Nat Rev Clin Oncol. 2018; 15:709-720.
  9. Cox AD, et al. Nat Rev Drug Discovery. 2014; 13:828-851.
  10. Gimple RC, et al. Front. Oncol. 2019:
  11. Neel N, et al. Genes Cancer. 2011;2(3):275-287.
  12. Ferrer I, et al. Lung Cancer. 2018;124;53-64.

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.