Resources

BRAF Codon 600 Mutation Detection by Pyrosequencing

Message
Performed at ARUP, Test Code BRAF PCR - 2002148, 2002524
Order as ESOT
http://ltd.aruplab.com/Tests/Pub/2002498


Test Code
BRAF Codon 600 Mutation


Alias/See Also
  • BRAF Gene Mutation Assay
  • BRAF Mutation Analysis
  • EGFR targeted therapy
  • sporadic Lynch Syndrome
  • V600E


CPT Codes
88381, 81210

Preferred Specimen
Tumor tissue. 


Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue. Protect from excessive heat. Transport tissue block or 5 unstained 5-micron slides. (Min: 3 slides). Tissue block will be returned after testing.
Transport block and/or slide(s) in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connectâ„¢ or contact ARUP Client Services at (800) 522-2787.


Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.


Specimen Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable 


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Decalcified specimens. 


Methodology
Polymerase Chain Reaction/Pyrosequencing

Setup Schedule
DNA isolation: Sun-Sat
Assay: Mon, Wed, Fri


Report Available
5-12 days


Reference Range
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.



Clinical Significance
Detect activating BRAF mutations at codon 600, which can indicate responsiveness to BRAF inhibitors in melanomas or resistance to anti-EGFR therapy in colorectal cancer. Useful in assessing prognosis of certain thyroid cancers. Can also be used within the Lynch syndrome reflex testing pathway (for colorectal cancer specimens only).




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.