title: Validation of the VE1 immunostain for the BRAF V600E mutation in melanoma.
abstract: BACKGROUND
  BRAF mutation status, and therefore eligibility for BRAF inhibitors, is currently determined by sequencing methods. We assessed the validity of VE1, a monoclonal antibody against the BRAF V600E mutant protein, in the detection of mutant BRAF V600E melanomas as classified by DNA pyrosequencing.
  
  
  METHODS
  The cases were 76 metastatic melanoma patients with only one known primary melanoma who had had BRAF codon 600 pyrosequencing of either their primary (n = 19), metastatic (n = 57) melanoma, or both (n = 17). All melanomas (n = 93) were immunostained with the BRAF VE1 antibody using a red detection system. The staining intensity of these specimens was scored from 0 to 3+ by a dermatopathologist. Scores of 0 and 1+ were considered as negative staining while scores of 2+ and 3+ were considered positive.
  
  
  RESULTS
  The VE1 antibody showed a sensitivity of 85% and a specificity of 100% as compared to DNA pyrosequencing results. There was 100% concordance between VE1 immunostaining of primary and metastatic melanomas from the same patient. V600K, V600Q, and V600R BRAF melanomas did not positively stain with VE1.
  
  
  CONCLUSIONS
  This hospital-based study finds high sensitivity and specificity for the BRAF VE1 immunostain in comparison to pyrosequencing in detection of BRAF V600E in melanomas.
authors.affiliation: Department of Dermatology, UNC School of Medicine, Chapel Hill, NC, USA.
authors.forename: Michelle V
authors.initials: MV
authors.lastname: Pearlstein
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Zedek
authors.forename: David W
authors.initials: DW
authors.lastname: Ollila
authors.forename: Amanda
authors.initials: A
authors.lastname: Treece
authors.forename: Margaret L
authors.initials: ML
authors.lastname: Gulley
authors.forename: Pamela A
authors.initials: PA
authors.lastname: Groben
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Thomas
mesh_terms: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor / Q000378:metabolism; D006801:Humans; D007150:Immunohistochemistry; D008545:Melanoma / Q000175:diagnosis* / Q000235:genetics / Q000378:metabolism; D009154:Mutation; D048493:Proto-Oncogene Proteins B-raf / Q000235:genetics / Q000378:metabolism*; D012680:Sensitivity and Specificity; D012878:Skin Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000378:metabolism
chemical_list: D000911:Antibodies, Monoclonal; D014408:Biomarkers, Tumor; C482119:BRAF protein, human; D048493:Proto-Oncogene Proteins B-raf
keywords: dermatopathology; immunohistochemistry; melanoma