Ordering RecommendationRecommendations when to order or not order the test. May include related or preferred tests.
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.
MnemonicUnique test identifier.
BRAF CFDNA
MethodologyProcess(es) used to perform the test.
Polymerase Chain Reaction
PerformedDays of the week the test is performed.
Varies
ReportedExpected turnaround time for a result, beginning when ARUP has received the specimen.
9-12 days
New York DOH Approval StatusIndicates test has been approved by the New York State Department of Health.
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.
Reference IntervalNormal range/expected value(s) for a specific disease state. May also include abnormal ranges.
Refer to report.
Interpretive DataBackground information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.
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.
NoteAdditional information related to the test.
Hotline History
N/A
CPT CodesThe American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ. CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
* 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.
AliasesOther names that describe the test. Synonyms.
BRAF V600E Mutation Detection in Circulating Cell-Free DNA by Digital Droplet PCR
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