|RAS/RAF Targeted Gene Panel by next generation sequencing [RASRAF]|
| WSLH Department:|| Cytogenetics|
|WSLH Test Code:||840C50|
|Includes:||This discrete RAS/RAF panel uses targeted next-generation sequencing to evaluate for somatic mutations within the BRAF (exons 11 and 15), HRAS (exons 2 and 3), NRAS (exons 2,3,4), and KRAS (exons 2,3,4) genes. This includes, but is not limited toc the testing of somatic mutations in KRAS codons 12, 13, 61, 117, 146; NRAS codons 12, 13, 61, 146; HRAS codons 12, 13, 61; and BRAF codons 594, 596 and 600.|
|Methodology:||**(CPT Codes: 81210, 81275, 81276, 81403, 81311)** Next Generation Sequencing|
|Availability:||Once a week.|
|Turn-around Time:||14 days|
|Recommended Uses:||Formalin-fixed, paraffin embedded tissue, whole blood or bone marrow aspirate|
|Specimen Requirements:||1 mL Whole Blood or Bone Marrow in lavender-top tube (EDTA)|
|Collection Kit/Container:|| |
|Patient Preparation:|| |
|Collection Instructions:||Batched runs begin on Monday or first working day of each week.|
|Specimen Handling and Transport:||Three slides each containing 5 microns (uM) of FFPE tissue should be sent. Second slide should be H&E stained with the tumor circled. Please indicate percent tumor on Intra-Lab Send-Out Form.
*Blood/Bone Marrow Aspirate - Whole Blood. Do not centrifuge.
*Transport at room temperature. Outreach: Transport with a cold pack. Avoid excessive heat.
*Provider must contact patient's insurance about coverage for this molecular test and then counsel the patient on out-of-pocket costs.|
|Unacceptable Conditions:||Blood/Bone Marrow Aspirate - Whole Blood. Do not centrifuge or freeze.|
|Requisition Form:||Cytogenetics Lab Neoplasia Diagnosis Form #132|
|Required Information:|| |
|Results include:||A written interpretive report is provided by the laboratory detailing all genetic variants detected and genes in the panel. The significance of genetic variants to pathogenicity and therapeutic response will be indicated whenever possible.|
|Limitations:||A "Not Detected" result may be due to either insufficient tissue or tumor present in the sample, tumor heterogeneity, to the presence of inhibitors or to bias or inefficiencies in PCR amplification. The 4 genes covered are not all sequenced in their entirety. Mutations outside the amplicons will not be detected. The limit of detection of this assay is estimated to be 5% at 500X coverage and 10% at 200X coverage and mutations below 100X coverage cannot reliably be detected. This technology cannot detect large insertions, deletions, duplications or genomic copy number variants. Rare or complex polymorphisms may be present that could lead to false negative or positive results.
*This test cannot differentiate between somatic or germline genetic variants. Additional testing may be necessary to clarify the significance of results if there is a potential for hereditary risk. It is recommended that patients receive genetic consultation where appropriate, to explain the implications of this test result, including probabilistic risk of disease and uncertainties, and the reproductive or medical options it raises. The presence or absence of cancer associated mutations does not guarantee either a positive or negative response to therapy. All test results should be interpreted in the context of patient's clinical presentation.|
|Additional Tests Recommended:|| |
|Additional Comments:||A "Detected" results indicates the presence of a variant. Inadequate specimen collection, processing and storage may invalidate test results. This test should not be used as the only criterion to form a clinical conclusion, instead, results should be correlated with other test results, patient symptoms and clinical presentation.
The variants nomenclature used is recommended by the Human Genome Variation Society (http://www.hgvs.org/mutnomen/).
The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.|
|Additional Tests Performed:|| |