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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

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Clinical Information

This test uses DNA extracted from the peripheral blood to evaluate for the presence of BRAF V600E and V600K alterations. The BRAF gene is a member of the mitogen-activated protein/extracellular signal-regulated (MAP/ERK) kinase pathway, which plays a role in cell proliferation and differentiation. Dysregulation of this pathway is a key factor in tumor progression and BRAF alterations occur frequently in many different tumor types. BRAF variant analysis aids in the diagnosis of cancer types including anaplastic and papillary thyroid carcinoma, hairy cell leukemia, and papillary craniopharyngioma.

 

BRAF V600E and V600K alterations are associated with response or resistance to specific targeted therapies in cancer. Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.

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

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.