BACKGROUND: We critically evaluated the available evidence on genomic tests in 
breast cancer to define their prognostic ability and likelihood to determine 
treatment benefit.
DESIGN: 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.