Classic view of this page
KRAS Mutation Analysis
Clinical Genetic Test
Help
offered by
PathGroup
View lab's test page
LinkOut
GTR Test Accession: Help GTR000571194.2
CAP
CANCERDIGESTIVE SYSTEMENDOCRINOLOGY ... View more
Last updated in GTR: 2020-02-26
View version history
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis; Predictive; Prognostic
Conditions (13): Help
Breast and/or ovarian cancer; Carcinoma of colon; Carcinoma of esophagus more...
Genes (1): Help
KRAS (12p12.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
Solid tumor cancer patients including but not limited to NSCLC …
Clinical validity: Help
Not provided
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
Ordering Information
Offered by: Help
PathGroup
View lab's website
View lab's test page
Test short name: Help
KRAS
Manufacturer's name: Help
n/a
Specimen Source: Help
  • Paraffin block
Who can order: Help
  • Health Care Provider
Test Order Code: Help
KRASSA
View other test codes
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
How to Order: Help
KRAS
Test development: Help
Test developed by laboratory but exempt from FDA oversight (eg. NYS CLEP approved, offered within a hospital or clinic)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Lab contact for this test, Test strategy
Conditions Help
Total conditions: 13
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Predictive; Prognostic
Clinical utility: Help
Guidance for selecting a drug therapy and/or dose
View citations (5)
  • Perincheri S, Hui P. KRAS mutation testing in clinical practice. Expert Rev Mol Diagn. 2015;15(3):375-84. doi:10.1586/14737159.2015.986102. Epub 2014 Dec 09. PMID: 25487540.
  • RAS Mutations Beyond KRAS Exon 2: A Review and Discussion of Clinical Trial Data. Cannon TL, et al. Curr Treat Options Oncol. 2015;16(7):33. doi:10.1007/s11864-015-0350-8. PMID: 26050230.
  • Haigis KM. KRAS Alleles: The Devil Is in the Detail. Trends Cancer. 2017;3(10):686-697. doi:10.1016/j.trecan.2017.08.006. Epub 2017 Sep 12. PMID: 28958387.
  • Analytical Validity and Clinical Utility of Tumor Biomarkers. Sorscher S, et al. JAMA Oncol. 2018;4(10):1432. doi:10.1001/jamaoncol.2018.1698. PMID: 30027205.
  • McClure RF, Ewalt MD, Crow J, Temple-Smolkin RL, Pullambhatla M, Sargent R, Kim AS. Clinical Significance of DNA Variants in Chronic Myeloid Neoplasms: A Report of the Association for Molecular Pathology. J Mol Diagn. 2018;20(6):717-737. doi:10.1016/j.jmoldx.2018.07.002. Epub 2018 Aug 20. PMID: 30138727.

Target population: Help
Solid tumor cancer patients including but not limited to NSCLC and CRC.
Recommended fields not provided:
Clinical validity, What is the protocol for interpreting a variation as a VUS?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Analytic sensitivity >99% when variant is present at >5% VAF with minimum of 20% tumor cells. Analytic specificity of >99%. Precision and reproducibility of >98%.
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
American College of Medical Genetics / College of American Pathologists, ACMG/CAP
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information
Consumer resources:

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.