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EndoPredict®: Local Testing

EndoPredict®

Fast, Reliable, and Decentralized​

EndoPredict is a second-generation gene expression test for ER+ HER2- breast cancer, developed specifically for use in local pathology laboratories. It provides both prognostic and predictive insights1-3, supporting confident chemotherapy decisions with high analytical4​ and clinical accuracy.5,6

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  • Available as a CE-IVD kit, EndoPredict is validated for routine use in molecular pathology labs and is already established in over 30 countries and more than 90 local laboratories worldwide.​
  • Installation and qualification at a new site takes just two days, guided by Eurobio’s experienced customer support team. This process ensures consistent, reproducible results – independent of where the test is performed.​

By enabling local testing, EndoPredict allows clinicians to access results quickly, without the delays or logistical challenges of sending samples abroad.​

Highly Reproducible in Local Laboratories​

EndoPredict consistently delivers the same quality of results, regardless of the pathological institute conducting the assay, as has been demonstrated in round-robin testing.7-9​ The variance and accuracy of the EndoPredict assays were determined using predefined reference values.​ ​Evaluation of the assay in 7 different molecular pathology laboratories in Germany, Austria, and Switzerland8​ showed:​
  1. ​Exceptional correlation with reference values – mean value of Pearson correlation coefficients, r= 0.996​
  2. All samples were assigned to the correct EndoPredict risk group, resulting in:​
  • Sensitivity and specificity of 100%​
  • Concordance of 100%​
  • Kappa of 1.0​

Results of the decentral measurement of 70 tumor samples from ten different tumors2​27

Similar results have been shown in a French round-robin trial9​, which has been repeated regularly over many years with consistently strong outcomes.

Flexible Testing – Surgical Specimens and Biopsies​

EndoPredict is validated for use on both surgical tumor specimens y core needle biopsies, ensuring maximum flexibility in clinical practice. This allows physicians to obtain reliable prognostic and predictive information at different stages of the patient journey – whether before surgery, to discuss individual therapy options with patients as soon as possible, or after surgery, to guide adjuvant treatment planning.​

​A comparison of test results between core biopsies and corresponding surgical breast cancer sections, analyzing the influence of biopsy-related tissue injury on the test result, revealed a high correlation between the paired samples. The molecular score was highly correlated between biopsies and tumour sections (r=0.92), and the concordance for the EndoPredict-based risk classification was excellent (overall agreement 95%, k=0.89).10​

​By enabling testing on both sample types, EndoPredict delivers consistent, high-quality results with the same proven analytical and clinical accuracy.​

EndoPredict® Testing – Fast, Local, Reliable

The EndoPredict prognostic and predictive breast cancer test is performed in certified local laboratories, delivering reliable results within just a few days.

Physicians can conveniently order EndoPredict through a wide network of participating labs.

Use the link below to find a local lab and place your order. Have questions? Contact us anytime – we’re here to help.

Test access and ordering
Contact us

Get the EndoPredict® Test in Your Lab​

EndoPredict is available as a CE-marked IVD kit that can be run in local molecular pathology laboratories after a comprehensive onsite training, provided by Eurobio Scientific.​

Interested in offering EndoPredict in your lab? Use the contact form below – we’ll evaluate the requirements together.

  1. Filipits M. et al.: A New Molecular Predictor of Distant Recurrence in ER-Positive, HER2-Negative Breast Cancer Adds Independent Information to Conventional Clinical Risk Factors. Clin. Cancer Res. 2011​
  2. Sestak I. et al.: Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019​
  3. Filipits M. et al.: Prediction of Distant Recurrence using EndoPredict among Women with ER+, HER2- Node- Positive and Node-Negative Breast Cancer Treated with Endocrine Therapy Only. Clin Cancer Res. 2019​
  4. EndoPredict® QS for QuantStudio™ 5 Dx Instruction Manual Version EN/03 2025​
  5. Buus R. et al.: Comparison of EndoPredict and EPclin With Oncotype DX Recurrence Score for Prediction of Risk of Distant Recurrence After Endocrine Therapy. J Natl Cancer Inst. 2016​
  6. Sestak I. et al.: Comparison of the Performance of 6 Prognostic Signatures for Estrogen Receptor-Positive Breast Cancer. A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018​
  7. Kronenwett R. et al.: Decentral gene expression analysis: analytical validation of the EndoPredict genomic multianalyte breast cancer prognosis test. BMC Cancer. 2012​
  8. Denkert C. et al.: Decentral gene expression analysis for ER+/Her2- breast cancer: results of a proficiency testing program for the EndoPredict assay. Virchows Arch. 2012​
  9. Lehmann-Che J. et al.: First French pilot quality assessment of the EndoPredict test for early luminal breast carcinoma. Anticancer Res. 2018​
  10. Muller B. M. et al.: The EndoPredict Gene-Expression Assay in Clinical Practice – Performance and Impact on Clinical Decisions. PloS ONE. 2013​

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