BRAF V600E Mutation Detection in Circulating Cell-Free DNA by Digital Droplet PCR
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.
Polymerase Chain Reaction
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.
Transport 20 mL whole blood in cfDNA BCT Tubes. (Min: 16 mL)
FFPE tissue. Whole blood collected in non-cfDNA BCT tubes.
Ambient: 5 days; Refrigerated: 5 days; Frozen: Unacceptable
Refer to report.
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.
|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|