BRAF Codon 600 Mutation Detection by Pyrosequencing
2002498
Ordering Recommendation
Evaluate suspected Lynch syndrome. Use to predict effectiveness of therapies targeting the EGFR pathway. Evaluate thyroid specimens (tissue blocks or formalin-fixed, paraffin-embedded cell blocks prepared from fine needle aspirates [FNA]) for BRAF mutations for purpose of diagnosis, prognosis, and possible therapeutics. For endometrial tissue evaluation, refer to MLH1 Promoter Methylation, Paraffin (2002499). For FNA direct smears, the preferred test is BRAF V600E Mutation Detection by Allele-Specific PCR, Fine Needle Aspirate (2006516).
Mnemonic
BRAF PCR
Methodology
Polymerase Chain Reaction/Pyrosequencing
Performed
DNA isolation: Sun-Sat
Assay:
Mon, Wed, Fri
Reported
10-14 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
Tumor tissue.  
Specimen Preparation
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 Connect™ or contact ARUP Client Services at (800) 522-2787.  
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Less than 25 percent tumor. Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Decalcified specimens.  
Remarks
Include surgical pathology report.  
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
   
Interpretive Data
Refer to report.

See Compliance Statement B: www.aruplab.com/CS
Statement B: 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
 
CPT Code(s)
88381; 81210
Components
Component Test Code*Component Chart NameLOINC
2002148Block ID57723-9
2002524BRAF Codon 600 Mutation Detection58483-9
* 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 Gene Mutation Assay
  • BRAF Mutation Analysis
  • EGFR targeted therapy
  • sporadic Lynch Syndrome
  • V600E