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

This test is New York DOH approved.

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


This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

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