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Test Code BRAFB Cell-Free DNA BRAF V600, Blood

Useful For

An alternative to invasive tissue biopsies for the determination of BRAF V600E and V600K alterations

 

Identification of patients with cancer who are most likely to benefit from targeted therapies

 

This test is not intended for serial monitoring of patients with cancer or as a screening test to identify cancer.

Method Name

Digital Droplet Polymerase Chain Reaction (ddPCR)

Reporting Name

cfDNA BRAF V600 Test, Blood

Specimen Type

Whole blood


Ordering Guidance


This test is not a prenatal screening test.



Shipping Instructions


1. Samples should be transported at ambient temperature or refrigerated (4° C)

2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit (T715)



Specimen Required


Supplies: Streck Black/Tan Top Tube Kit (T715)

Container/Tube: Streck Cell-Free DNA blood collection kit

Specimen Volume: Two 10-mL Streck Cell-Free DNA blood collection tubes

Additional Information: Only blood collected in Streck Cell-Free DNA tubes will be accepted for analysis. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.


Specimen Minimum Volume

One 10 mL Streck cell-free DNA blood collection tube

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole blood Ambient (preferred) 7 days
  Refrigerated  7 days

Interpretation

The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.

Clinical Reference

1. Sanmamed MJ, Fernandez-Landazuri S, Rodriguez C, et al: Quantitative cell-free circulating BRAFV600E mutation analysis by use of droplet digital PCR in the follow-up of patients with melanoma being treated with BRAF inhibitors. Clin Chem. 2015;61(1):297-304

2. Schwarzenbach H, Hoon DS, Pantel K: Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer. 2011 Jun;11(6):426-437

3. Johnson DB, Sosman JA: Update on the targeted therapy of melanoma. Curr Treat Options Oncol. 2013 Jun 14;(2):280-292

4. McArthur GA, Chapman PB, Robert C, et al: Safety and efficacy of vemurafenib in BRAF (V600E) and BRAF (V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomized, open-label study. Lancet Oncol. 2014 Mar;15(3):323-332

Day(s) Performed

Varies

Report Available

5 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81210

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BRAFB cfDNA BRAF V600 Test, Blood 93690-6

 

Result ID Test Result Name Result LOINC Value
48044 Result Summary 50397-9
48045 Result 93690-6
48046 Interpretation 69047-9
48047 Additional Information 48767-8
48048 Specimen 31208-2
48049 Source 31208-2
48050 Released By 18771-6
606201 Method 85069-3
606202 Disclaimer 62364-5

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.

Reference Values

An interpretive report will be provided.