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Alternative Name
Biomarker Assist™ KRAS G12C Single Gene Test Program (SGT), KRAS Sponsored Testing Program
Methodology
Molecular
Test Description

Bi-directional sequencing of exons 2, 3, and 4 of the KRAS (includes G12C mutation) gene including codons 12, 13, 59, 61, 117, and 146. High-sensitivity sequencing is used for enhanced detection of mutations in codons 12 and 13.

This test is only available through the Amgen-sponsored Biomarker AssistTM KRAS G12C Single Gene Test Program for patients with stage IV non-small cell lung carcinoma (NSCLC). A separate test request form is required. Please visit the Test Program webpage for more information and to download the KRAS G12C Single Gene Test Request Form.

To order additional testing outside the KRAS G12C Single Gene Test Program on the same specimen, please send the tissue block rather than cut slides and submit the NeoGenomics Test Request concurrently with the KRAS Test Request Form.

Clinical Significance

The KRAS G12C mutation is the most prevalent oncogenic driver in NSCLC, detected in approximately 13% of patients.

Specimen Requirements
  • FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

CPT Code(s)*
Inquire for testing program details.
New York Approved
Yes
Level of Service
Global
Turnaround Time

7 days

References
  1. Pakkala S, et al. JCI Insight. 2018;3 e120858.
  2. Nassar AH, Adib E, Kwiatkowski DJ. N Engl J Med. 2021;384:185-187. doi: 10.1056/NEJMc2030638.

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.