Ordering Recommendation

Determine BRAF V600E mutation status in patients with solid tumors to select candidates for targeted therapy with kinase inhibitors (BRAF and/or MEK). Monitor response to therapy and disease progression in patients carrying BRAF V600E mutation.

Mnemonic
BRAF CFDNA
Methodology

Polymerase Chain Reaction

Performed

Varies

Reported

9-12 days

New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Specimen Required
Patient Preparation
Collect

Whole blood in two 10mL Cell-Free DNA (cfDNA) BCT Tubes. Specimens must be collected using the Kit, Cell-Free DNA Blood Collection Tube (ARUP Supply #52358) available online through eSupply using ARUP Connect or contact ARUP Client Services at (800) 522-2787.

Specimen Preparation

Transport 20 mL whole blood in cfDNA BCT Tubes. (Min: 16 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

FFPE tissue. Whole blood collected in non-cfDNA BCT tubes.

Remarks
Stability

Ambient: 5 days; Refrigerated: 5 days; Frozen: Unacceptable

Reference Interval

Refer to report.

Interpretive Data



Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note
Hotline History
N/A
CPT Codes

81210

Components
Component Test Code* Component Chart Name LOINC
2013922 BRAF V600E cfDNA Result 58415-1
2013924 BRAF V600E cfDNA Mutant Allele Frequency
2013925 BRAF V600E cfDNA Mutant copies/mL
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
BRAF V600E Mutation Detection in Circulating Cell-Free DNA by Digital Droplet PCR