title: Utility of prognostic genomic tests in breast cancer practice: The IMPAKT 2012 Working Group Consensus Statement.
abstract: BACKGROUND
  We critically evaluated the available evidence on genomic tests in breast cancer to define their prognostic ability and likelihood to determine treatment benefit.
  
  
  METHODS
  Independent evaluation of six genomic tests [Oncotype Dx™, MammaPrint(®), Genomic Grade Index, PAM50 (ROR-S), Breast Cancer Index, and EndoPredict] was carried out by a panel of experts in three parameters: analytical validity, clinical validity, and clinical utility based on the principles of the EGAPP criteria. PANEL STATEMENTS: The majority of the working group members found the available evidence on the analytical and clinical validity of Oncotype Dx™ and MammaPrint(®) to be convincing. None of the genomic tests demonstrated robust evidence of clinical utility: it was not clear from the current evidence that modifying treatment decisions based on the results of a given genomic test could result in improving clinical outcome.
  
  
  CONCLUSIONS
  The IMPAKT 2012 Working Group proposed the following recommendations: (i) a need to develop models that integrate clinicopathologic factors along with genomic tests; (ii) demonstration of clinical utility should be made in the context of a prospective randomized trial; and (iii) the creation of registries for patients who are subjected to genomic testing in the daily practice.
authors: Breast Cancer Translational Research Laboratory BCTL, J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors: H A
authors: HA
authors: Azim
authors: S
authors: S
authors: Michiels
authors: F
authors: F
authors: Zagouri
authors: S
authors: S
authors: Delaloge
authors: M
authors: M
authors: Filipits
authors: M
authors: M
authors: Namer
authors: P
authors: P
authors: Neven
authors: W F
authors: WF
authors: Symmans
authors: A
authors: A
authors: Thompson
authors: F
authors: F
authors: André
authors: S
authors: S
authors: Loi
authors: C
authors: C
authors: Swanton
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards; D015999:Multivariate Analysis; D020411:Oligonucleotide Array Sequence Analysis; D017410:Practice Guidelines as Topic; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction