Cell-Free DNA BRAF V600, Blood (BRAFB)

Marshfield Lab Public WebSite

Marshfield Clinic Public WebSite

Test Code: BRAFBSO

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

Synonyms/Keywords

Melanoma

Cell free DNA

cfDNA

cell-free DNA

circulating tumor DNA

liquid biopsy

BRAF

V600E

V600K

Circulating tumor cells

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.

Specimen Requirements

Fasting Required	Specimen Type	Preferred Container/Tube	Acceptable Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)	Pediatric Minimum Volume (no repeat)
No	Whole Blood	Streck Black/Tan Top Tube Kit (T715)		Two, 10-mL Streck cell-free DNA (cfDNA) blood collection tubes	One 10 mL Streck cell-free DNA tube

Collection Processing Instructions

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

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

Specimen Stability Information

Specimen Type	Temperature	Time
Whole Blood	Ambient (preferred)	7 days
Whole Blood	Refrigerated	7 days

Rejection Criteria

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

Interference

Patients with a negative test result may still harbor a V600E or V600K alteration. Variant testing of a tissue specimen for BRAF alterations should be considered for patients with a negative result with this test.

The limit of detection of this assay for the detection of BRAF V600E and V600K alterations is influenced by the amount of cell-free DNA (cfDNA) in the blood. This is a biological variable that cannot be controlled.

This assay was designed to detect V600E and V600K alterations. The sensitivity for rarer V600 alterations has not been established.

This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.

This test cannot differentiate between somatic and germline alterations.

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Mayo Clinic Laboratories	Monday through Friday	5-10 days	Digital Droplet Polymerase Chain Reaction (ddPCR)

Reference Lab

Mayo Clinic Laboratories

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.

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.

Reference Range Information

An interpretive report will be provided.

Interpretation

An interpretive report will be provided.

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
81210		1	BRAF, gene analysis, V600 variants

Synonyms/Keywords

Melanoma

Cell free DNA

cfDNA

cell-free DNA

circulating tumor DNA

liquid biopsy

BRAF

V600E

V600K

Circulating tumor cells

Ordering Applications

Ordering Application	Description
COM	Cell-Free DNA BRAF V600, Blood (BRAFB)
Cerner	Cell-Free DNA BRAF V600, Blood (BRAFB)

If the ordering application you are looking for is not listed, contact your local laboratory for assistance.

Specimen Requirements

Fasting Required	Specimen Type	Preferred Container/Tube	Acceptable Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)	Pediatric Minimum Volume (no repeat)
No	Whole Blood	Streck Black/Tan Top Tube Kit (T715)		Two, 10-mL Streck cell-free DNA (cfDNA) blood collection tubes	One 10 mL Streck cell-free DNA tube

Collection Processing

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

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

Specimen Stability Information

Specimen Type	Temperature	Time
Whole Blood	Ambient (preferred)	7 days
Whole Blood	Refrigerated	7 days

Rejection Criteria

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

Interference

This assay was designed to detect V600E and V600K alterations. The sensitivity for rarer V600 alterations has not been established.

This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.

This test cannot differentiate between somatic and germline alterations.

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.

Reference Range Information

An interpretive report will be provided.

Interpretation

An interpretive report will be provided.

For more information visit:

http://labtestsonline.org

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Mayo Clinic Laboratories	Monday through Friday	5-10 days	Digital Droplet Polymerase Chain Reaction (ddPCR)

Reference Lab

Mayo Clinic Laboratories

For billing questions, see Contacts

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
81210		1	BRAF, gene analysis, V600 variants

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For most current information refer to the Marshfield Laboratory online reference manual.

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26411 Cell-Free DNA BRAF V600, Blood (BRAFB)