title: Eighteen months clinical experience with the GeneSearch breast lymph node assay.
abstract: BACKGROUND
  The accuracy of a molecular reverse transcriptase-polymerase chain reaction (RT-PCR)-based assay for metastases detection in axillary sentinel lymph nodes (SLNs) has recently been validated in our institution and adopted as an intraoperative test for breast cancer patient management.
  
  
  METHODS
  Molecular assay performance was compared to standard postoperative histology in 253 consecutive patients with clinically node-negative T1 early breast cancer (<2 cm).
  
  
  RESULTS
  The molecular assay correctly identified 26/27 macrometastases and 11/15 micrometastases. Overall concordance with histopathology was 93%, with 87% sensitivity, 94% specificity, and 75% positive and 97% negative predictive values. The molecular assay was positive in 13/14 patients with SLNs and nonsentinel lymph node (axillary lymph node [ALN])-positive histology. Notably, 2/12 patients with assay-positive/histology-negative SLNs exhibited ALN positivity.
  
  
  CONCLUSIONS
  This molecular assay can raise the standard of care for patient management as its accuracy is similar to that of standard postoperative histology with the advantage of being standardized, objective, and fast enough for intraoperative use.
authors.affiliation: Department of Surgery, Jules Bordet Institute, Université Libre de Bruxelles, Belgium.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Veys
authors.forename: Virginie
authors.initials: V
authors.lastname: Durbecq
authors.forename: Samira
authors.initials: S
authors.lastname: Majjaj
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Schobbens
authors.forename: Danielle
authors.initials: D
authors.lastname: Noterman
authors.forename: Nicolas
authors.initials: N
authors.lastname: Sirtaine
authors.forename: Maria Dolores Martin
authors.initials: MD
authors.lastname: Martinez
authors.forename: Dina
authors.initials: D
authors.lastname: Hertens
authors.forename: Francesco
authors.initials: F
authors.lastname: Feoli
authors.forename: Pierre
authors.initials: P
authors.lastname: Bourgeois
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Nogaret
authors.forename: Denis
authors.initials: D
authors.lastname: Larsimont
mesh_terms: D001365:Axilla; D014408:Biomarkers, Tumor / Q000235:genetics; D001943:Breast Neoplasms / Q000235:genetics / Q000473:pathology*; D005260:Female; D006801:Humans; D053539:Keratin-19 / Q000235:genetics*; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000175:diagnosis*; D060785:Mammaglobin A; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000235:genetics*; D011237:Predictive Value of Tests; D012313:RNA / Q000032:analysis; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy; D014598:Uteroglobin / Q000235:genetics*
chemical_list: D014408:Biomarkers, Tumor; D053539:Keratin-19; D060785:Mammaglobin A; D009363:Neoplasm Proteins; C556448:SCGB2A2 protein, human; D012313:RNA; D014598:Uteroglobin