Cell-Free DNA BRAF V600, Blood
Use
This test is designed as an alternative to invasive tissue biopsies to detect BRAF V600E and V600K alterations in cancer patients, particularly in melanoma cases. It identifies patients most likely to benefit from targeted therapies. The BRAF gene, a part of the MAP/ERK kinase pathway, plays a significant role in cell proliferation and differentiation, with its alterations being a critical factor in tumor progression across various cancers.
Special Instructions
This test is not intended for serial monitoring or for screening purposes. Only blood collected in Streck Cell-Free DNA tubes will be accepted for analysis. Whole blood will be processed to platelet-poor plasma before cfDNA isolation. The test has not been clinically validated as a monitoring tool for therapy response or early tumor detection.
Limitations
The test's detection limit is influenced by cfDNA concentration. It is designed for specific BRAF V600E and V600K alterations and does not cover rarer V600 variants. Negative results do not preclude the presence of alterations; confirmatory tissue testing is recommended. It cannot differentiate somatic from germline mutations; further testing might be needed for potential hereditary implications.
New York Approved
Methodology
PCR-based (ddPCR)
Biomarkers
LOINC Codes
- 93690-6
- 50397-9
- 93690-6
- 69047-9
- 48767-8
- 31208-2
- 18771-6
- 85069-3
- 62364-5
Result Turnaround Time
5-10 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
Two 10-mL Streck Cell-Free DNA blood collection tubes
Minimum Volume
One 10 mL Streck cell-free DNA blood collection tube
Container
Streck Cell-Free DNA blood collection kit
Storage Instructions
Samples should be transported at ambient temperature or refrigerated (4 degrees C)
Causes for Rejection
All specimens will be evaluated for test suitability.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 7 days |