Test Code BRAFBSO Cell-Free DNA BRAF V600, Blood
Additional Codes
Mayo Test Code: BRAFB
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, BloodSpecimen Type
Whole bloodOrdering 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 |
|---|---|---|
| Whole blood | Ambient (preferred) | 7 days |
| Refrigerated | 7 days |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Cautions
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. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk.
Day(s) Performed
Varies
Report Available
5 to 10 daysPerforming 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.