Find Locations
For hours, walk-ins and appointments.Special Instructions
Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. BRAF testing will be delayed if the pathology report is not received.
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Specimen Requirements
Specimen
Solid tumor: Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides; thyroid fine needle aspirate (FNA). Leukemia: whole blood or bone marrow
Volume
FFPE tissue block or four unstained slides and one matching H&E-stained slide at 5 μM; 5 to 10 mL FNA in CytoLyt container; 3 to 5 mL whole blood, 1 to 2 mL bone marrow
Minimum Volume
Two unstained slides and one matching H&E-stained slide at 5 μM. Sample with >4mm2 and greater than or equal to 50% tumor content are preferred; 5 mL FNA; 3 mL blood, 1 mL bone marrow
Container
FFPE tissue block or slides, lavender-top (EDTA) tube, green-top (sodium heparin) tube, yellow-top (ACD-A) tube, FNA CytoLyt container, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) tube
Storage Instructions
Maintain specimen at room temperature. If specimen is to be stored prior to shipment, store at 2°C to 8°C. Store FFPE block or slides, FNA in CytoLyt container at room temperature.
Causes for Rejection
Tumor block containing no tumor; broken or stained slides; specimen does not meet collection criteria; frozen whole blood, marrow, or cell pellet; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contamination by another specimen; specimens containing suspicious foreign material
Test Details
Use
BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. This test will detect all V600 mutations of the BRAF oncogene frequently found in human cancers, such as melanoma, colorectal cancer, lung cancer, ovarian cancer, thyroid cancer, and hairy cell leukemia, allowing the determination of drug response, aiding the diagnosis and providing prognosis information. More than 90% of mutations are the V600E (c1799T>A) mutation, but other V600 mutations have been reported.
This test can distinquish the following BRAF V600 mutations: V600E, V600E2, V600K, V600D, V600R, V600A, V600G, V600M, V600L.
Limitations
This assay is able to detect 5% mutation in a background of wild-type DNA.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Methodology
SNaPshot Multiplex PCR (primer extension-based method)
References
Benson AB 3rd, Bekaii-Saab T, Chan E, et al. Rectal cancer. Natl Compr Canc Netw. 2012 Dec 1; 10(12):1528-1564. 23221790
Benson AB 3rd, Venook AP, Bekaii-Saab T, et al. Colon cancer, version 3.2014. J Natl Compr Canc Netw. 2014 Jul; 12(7):1028-1059. 24994923
Ettinger DS, Wood DE, Akerley W, et al. Non-small cell lung cancer, version 1. J Natl Compr Canc Netw. 2014 Dec; 12(12):1738-1761. 25505215
Kudchadkar R, Gibney G, Sondak VK. Integrating molecular biomarkers into current clinical management in melanoma. Methods Mol Biol. 2014; 1102:27-42. 24258972
Misale S, Di Nicolantonio F, Sartore-Bianchi A, Siena S, Bardelli A. Resistance to anti-EGFR therapy in colorectal cancer: From heterogeneity to convergent evolution to convergent evolution. Cancer Discov. 2014 Nov; 4(11)1269-1280. 25293556
NCCN Clinical Practice Guidelines in Oncology: Hairy Cell Leukemia v4.2014.
Ohashi K, Sequist LV, Arcila ME, et al. Lung cancers with acquired resistance to EGFR inhibitors occasionally harbor BRAF gene mutations but lack mutations in KRAS, NRAS, or MEK1. Proc Natl Acad Sci USA. 2012 Jul 31; 109(31):E2127-E2133. 22773810
Pakneshan S, Salajegheh A, Smith RA, Lam AK. Clinicopathological relevance of BRAF mutations in human cancer. Pathology. 2013 Jun; 45(4):346-356. 23594689
Sharma SG, Gulley ML. BRAF mutation testing in colorectal cancer. Arch Pathol Lab Med. 2010 Aug; 134(8):1225-1228. 20670148
Tuttle RM, Haddad RI, Ball DW, et al. Thyroid carcinoma, version 2. 2014. J Natl Compr Canc Netw. 2014 Dec; 12(12);1671-1680. 25505208
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 481030 | BRAF Gene Mutation Analysis | 481031 | Results: | 58483-9 | ||
| 481030 | BRAF Gene Mutation Analysis | 481032 | Indications: | 42349-1 | ||
| 481030 | BRAF Gene Mutation Analysis | 481033 | Specimen Location: | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481034 | Specimen Type: | 31208-2 | ||
| 481030 | BRAF Gene Mutation Analysis | 481035 | Block #: | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481076 | Nucleotide Change: | 48004-6 | ||
| 481030 | BRAF Gene Mutation Analysis | 481079 | Amino Acid Change: | 48005-3 | ||
| 481030 | BRAF Gene Mutation Analysis | 481521 | Background: | 77202-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481749 | Methodology: | 49549-9 | ||
| 481030 | BRAF Gene Mutation Analysis | 481059 | References: | 75608-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481081 | Director Review: | 72486-4 | ||
| 481030 | BRAF Gene Mutation Analysis | 480903 | Microdissection Performed | 8100-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481181 | Referring Physician | 18781-5 | ||
| 481030 | BRAF Gene Mutation Analysis | 481182 | Treating Physician | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481183 | Body Site | 39111-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481168 | Client Specimen ID | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481172 | Specimens Received | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481173 | Clinical Data | 55752-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481175 | Interpretation | 51968-6 | ||
| 481030 | BRAF Gene Mutation Analysis | 481176 | Analytical Results | 53844-7 | ||
| 481030 | BRAF Gene Mutation Analysis | 481177 | Comments | 77202-0 | ||
| 481030 | BRAF Gene Mutation Analysis | 481178 | Signed By | 19139-5 | ||
| 481030 | BRAF Gene Mutation Analysis | 481179 | Disclaimers | N/A | ||
| 481030 | BRAF Gene Mutation Analysis | 481180 | 51969-4 |
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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf