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Test ID 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 melanoma who are most likely to benefit from targeted therapies

 

This test is not intended for serial monitoring of patients with malignant melanoma, evaluating patients with other malignancies, or as a screening test to identify cancer.

Genetics Test Information

This test evaluates cell-free DNA (cfDNA) in the peripheral blood for the presence of BRAF V600E or V600K alterations in patients with melanoma and can be used to determine if these patients are candidates for targeted therapies.

 

This test is not validated for serial monitoring of patients with malignant melanoma, nor should it be used for evaluating patients with other malignancies. This test is also not intended as a screening test to identify cancer.

Highlights

This test evaluates peripheral blood for BRAF alterations in cell-free DNA.

 

Detection of BRAF alterations in melanoma patients can be used as an alternative for BRAF analysis of tissue.

 

Current data suggests that the efficacy of BRAF-targeted therapy and anti-MEK therapy in melanoma is limited to patients whose tumors harbor a V600E or V600K alteration.

Method Name

Digital Droplet Polymerase Chain Reaction (ddPCR)

Reporting Name

cfDNA BRAF V600 Test, Blood

Specimen Type

Whole blood


Advisory Information


This test is not a prenatal screening test. To evaluate for the presence of common fetal chromosome abnormalities using cell-free DNA, see NIPS / Cell-Free DNA Prenatal Screen, Blood.



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)

Specimen Volume: Two, 10-mL Streck cell-free DNA (cfDNA) blood collection tubes

Additional Information:

1. Only blood collected in Streck cfDNA tubes will be accepted for analysis.

2. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.


Specimen Minimum Volume

One 10 mL Streck cell-free DNA tube

Specimen Stability Information

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

Day(s) and Time(s) Performed

Monday through Friday; Varies

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. This test has not been cleared or approved by the U.S. 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

NY State Approved

Yes

Forms

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