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Comparison of the RNA-based EndoPredict multigene test between core biopsies and corresponding surgical breast cancer sections
  1. Berit Maria Müller1,
  2. Jan C Brase2,
  3. Franziska Haufe2,
  4. Karsten E Weber2,
  5. Jan Budzies1,
  6. Christoph Petry2,
  7. Judith Prinzler1,
  8. Ralf Kronenwett2,
  9. Manfred Dietel1,
  10. Carsten Denkert1
  1. 1Institute of Pathology, Charité–Universitätsmedizin Berlin, Berlin, Germany
  2. 2Sividon Diagnostics, Cologne, Germany
  1. Correspondence to Dr Berit Maria Müller, Institute of Pathology, Charité–Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, Berlin D-10117, Germany; berit.mueller{at}


Aim This study compared the perfomance of the RNA-based EndoPredict multigene test on core biopsies and surgical breast cancer specimens and analysed the influence of biopsy-induced tissue injuries on the test result.

Methods 80 formalin-fixed paraffin-embedded samples comprising paired biopsies and surgical specimens from 40 ER-positive, HER2-negative patients were evaluated. Total RNA was extracted and the EndoPredict score was determined.

Results RNA yield was considerably lower in core biopsies, but sufficient to measure the assay in all samples. The EndoPredict score was highly correlated between paired samples (Pearson r=0.92), with an excellent concordance of classification into a low or high risk of metastasis (overall agreement 95%).

Conclusions The measurements are comparable between core biopsies and surgical sections, which suggest that the EndoPredict assay can be performed on core biopsy tissue. Inflammatory changes induced by presurgical biopsies had no significant effect on the RNA-based risk assessment in surgical specimens.

  • Breast
  • breast cancer
  • breast pathology
  • cancer
  • cancer genetics
  • cancer research
  • EGFR
  • endocrine pathology
  • gynaecological pathology
  • molecular oncology
  • molecular pathology
  • oncology
  • ovary
  • statistics
  • tumour markers

Statistics from


  • Competing interests KEW, CP, MD, RK and CD are shareholders in Sividon Diagnostics. The remaining authors report no competing interests.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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