Mutation Tests
KRAS Test
Clinical Relevance
KRAS testing may be performed to assist in treatment selection for colorectal cancer and prognosis in non-small cell lung cancer.
Colorectal Cancer
Clinical practice guidelines from ASCO and the National Comprehensive Cancer Network have recommended KRAS mutation testing at codons 12 and 13 for all patients with metastatic CRC being considered for anti-EGFR monoclonal antibody therapy, such as Erbitux® (cetuximab) or Vectibix® (panitumumab).1-4
KRAS gene is mutated in approximately 40% of colorectal cancers (CRC), and mutations are associated with resistance to anti-epidermal growth factor receptor (anti-EGFR) targeted therapies.1,2
Non-Small Cell Lung Cancer
In non-squamous non-small cell lung cancer (NSCLC), the presence of KRAS mutations may be prognostic of poor survival for patients, when compared to the absence of KRAS mutations.5
KRAS mutations may also be associated with intrinsic resistance to EGFR tyrosine kinase inhibitors (TKI), such as Tarceva® (erlotinib) and Iressa® (gefitinib).4,5
Test Method Description
Prior to DNA extraction, submitted tissues are reviewed by a pathologist and tumor areas are selected for microdissection, if needed, to enrich for tumor cells.
All DNA samples are assessed for quality and adequate quantity by real-time PCR assay utilizing Amplification Refractory Mutation System (ARMS®) and Scorpions® technology prior to mutation testing.
The KRAS test can detect the presence of seven common mutations (Gly12Ala, Gly12Asp, Gly12Arg, Gly12Cys, Gly12Ser, Gly12Val, and Gly13Asp) found in codons 12 and 13 of the KRAS oncogene.
The level of detection for all mutations is between 1 – 5% against a background of wild-type genomic DNA.
View Sample Report – Colorectal Cancer
View Sample Report – Non-Small Cell Lung Cancer
Turnaround Time
Following Tissue of Origin Test: up to five business days.
Orders independent of Tissue of Origin Test: three to seven business days
References
1. Monzon, et al. Arch Pathol Lab Med 2009 133: 1600-1606
2. Wang, et al. Adv Anat Path 2010 17:23-32
3. ASCO Provisional Clinical Opinion. J Clin Onc. 2009 27: 2091-2096
4. Refer to NCCN Guidelines at www.NCCN.org
5. Riely et al. Proc Am Thorac Soc 2009 6(2):201-205
Erbitux® is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company.
Vectibix® is a registered trademark of Amgen.
Tarceva® is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies
Iressa® is a registered trademark of the AstraZeneca group of companies.
ARMS® is a registered trademark of AstraZeneca UK Limited.
Scorpions® is a registered trademark of QIAGEN.