KRAS, BRAF, NRAS and MSI Mutation Analysis
Clinical Genetic Test
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offered by
GTR Test Accession: Help GTR000575335.1
CAP
CANCERINHERITED DISEASEENDOCRINOLOGY ... View more
Last updated in GTR: 2020-03-03
Last annual review date for the lab: 2022-12-28 Past due LinkOut
At a Glance
Diagnosis; Predictive; Prognostic
Carcinoma of pancreas; Acute myeloid leukemia; Breast and/or ovarian cancer; ...
Genes (3): Help
BRAF (7q34), KRAS (12p12.1), NRAS (1p13.2)
Molecular Genetics - Targeted variant analysis: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Solid tumor cancer patients including but not limited to NSCLC,Colorectal …
Not provided
Not provided
Ordering Information
Test short name: Help
KRAS_BRAF_NRAS_MSI
Specimen Source: Help
Who can order: Help
  • Health Care Provider
Test Order Code: Help
KRAS_BRAF_NRAS_MSI
View other test codes
CPT codes: Help
**AMA CPT codes notice
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_BRAF_NRAS_MSI
Test development: Help
Test developed by laboratory (no manufacturer test name)
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Conditions Help
Total conditions: 23
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 3
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
Target population: Help
Solid tumor cancer patients including but not limited to NSCLC,Colorectal carcinoma, endometrial carcinoma, and solid tumor patients exploring certain immune checkpoint blockade therapies
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
KRAS, BRAF, NRAS: 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%. MSI: Analytic sensitivity is approximately 5%. Analytic specificity >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:
Regulatory Approval
FDA Review: Help
Category: FDA exercises enforcement discretion
Additional Information

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