title: Dual color chromogenic in situ hybridization for determination of HER2 status in breast cancer: a large comparative study to current state of the art fluorescence in situ hybridization.
abstract: BACKGROUND
  Chromogenic in situ hybridization (CISH) is fast becoming a well established technique for easy and sensitive determination of HER2 gene status in breast cancer. However, for the chromogenic method to achieve status as a safe and reliable technique, the method needs to be validated against already known and validated FISH techniques.
  
  
  METHODS
  Here it is reported from a comparative study where HER2 gene status obtained by HER2 CISH pharmDx™ Kit was compared to HER2 gene status obtained by the FDA approved HER2 FISH pharmDx™ Kit and the PathVysion HER-2 DNA probe Kit. The study included 365 formalin fixed and paraffin-embedded invasive breast cancer tissue specimens collected consecutively at a US reference laboratory.
  
  
  RESULTS
  The data obtained revealed an overall HER2 status concordance of approximately 98% for comparisons of HER2 CISH pharmDx™ Kit to both HER2 FISH pharmDx™ Kit and PathVysion HER-2 DNA Probe Kit.
  
  
  CONCLUSIONS
  The concordance between results obtained using the recently FDA approved HER2 CISH pharmDx™ Kit with previously FDA approved FISH techniques for HER2 gene status determination indicate that the HER2 CISH pharmDx™ Kit is a reliable chromogenic alternative to fluorescence-based methods.
authors.affiliation: Dako Denmark A/S, Produktionsvej 42, DK-2600 Glostrup, Denmark. jens.mollerup@dako.com.
authors.forename: Jens
authors.initials: J
authors.lastname: Mollerup
authors.forename: Ulla
authors.initials: U
authors.lastname: Henriksen
authors.forename: Sven
authors.initials: S
authors.lastname: Müller
authors.forename: Andreas
authors.initials: A
authors.lastname: Schønau