EndoPredict breast cancer testing

Results That Help You Tailor Breast Cancer Treatment Decisions

EndoPredict® Provides Three Important Results
For Initial And Long-Term Treatment Planning In Breast Cancer

EndoPredict is a prognostic and predictive second generation gene expression test that combines tumor biology and pathology to accurately predict the individual risk of early and late recurrence.

EndoPredict enables reliable chemotherapy decisions with individualized 10-year risk and absolute chemotherapy benefit information.

EndoPredict is the only gene expression test that predicts distant recurrence up to 15 years and allows informed decisions on extended endocrine therapy.
EndoPredict provides a comprehensive test result with an individual EPclin Risk Score and a clear risk classification.

Second Generation Tests Include Genes That Predict Both Early And Late Recurrence

More Accuracy For Your Patients

As a second generation test, EndoPredict includes genes that predict both early and late metastasis to provide the highest prognostic power.

EndoPredict genes for early and late recurrence

Second Generation Tests Include Clinicopathological Factors For Best Prognostic Performance

The EndoPredict algorithm integrates the 12-Gene Molecular Score (tumor biology) with clinicopathological features (tumor size and nodal status). All three factors are important to assess recurrence risk and to predict individual chemotherapy benefit. 

Second Generation vs. First Generation

In the TransATAC study, the prognostic abilities of the leading first generation and the second generation test EndoPredict were compared head-to-head. A total of 928 patients treated with 5 years endocrine therapy only were included. Prognostic accuracy was compared by a standard statistic for prognostic power (x2). Head-to-head EndoPredict clearly outperforms the leading first generation tests.

Comparison of the prognostic power of EndoPredict with the leading first generation test in TransATAC

The χ2-value is a standard statistic for prognostic power that is used to compare prognostic accuracy of different tests. The greater the χ2-value, the better is the prognostic power of a test. The χ2-value reflects the prognostic power of the continuous score independent from cut-off values.

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 Jul 10;108(11)

Second Generation Tests Can Be Performed Locally

Local And Central Testing

EndoPredict is available as a service performed by Myriad Genetics and as a CE-IVD kit that can be run in local molecular pathology laboratories after a comprehensive onsite training.

This enables the pathologist to provide results within two days. Treatment decisions can be made without unnecessary delay for maximized patient benefit.

EndoPredict consistently delivers the same quality of results, regardless of the certified laboratory conducting the assay, as demonstrated in round-robin testing.

Dubsky P. et al.: The EndoPredict Score Provides Prognostic Information on Late Distant Metastases in ER+/HER2- Breast Cancer Patients. BJC. 2013;109:2959–2964
Kronenwett R. et al.: Decentral Gene Expression Analysis: Analytical Validation of the EndoPredict Genomic Multianalyte Breast Cancer Prognosis Test. BMC Cancer. 2012;12:456
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;460:251-259
Lehmann-Che J. et al.: First French Pilot Quality Assessment of the EndoPredict Test for Early Luminal Breast Carcinoma. Anticancer Res. 2018;38:2909-14

One Test - Three Clinical Answers

Risk At 10 Years – Your Patient's Clear Low Or High Risk Result

EndoPredict provides an individualized test result allowing a quick, easy to interpret risk assessment that enables reliable chemotherapy decisions.

The result report indicates the patient’s risk of recurrence within years 0-10 after diagnosis on a continuous curve.

Likelihood of distant recurrence within years 0-10 for patients treated with 5 years of endocrine therapy alone
Validated in four prospective-retrospective studies of more than 3,200 patients. Consistently identified a true large low risk group.

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;17(18):6012-6020
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;25:3865-3872
Dubsky P. et al.: EndoPredict Improves the Prognostic Classification Derived from Common Clinical Guidelines in ER-Positive, HER2-Negative Early Breast Cancer. Ann Oncol. 2013;24:640-647
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 Jul 10;108(11)
Martin M. et al.: Clinical Validation of the EndoPredict Test in Node-Positive, Chemotherapy-Treated ER+/HER2- Breast Cancer Patients: Results from the GEICAM 9906 Trial. BCR. 2014; 16:R38

Chemotherapy Benefit – Your Patient's Individual Absolute Benefit

EndoPredict provides the effect of chemotherapy on recurrence risk after 10 years to ensure that chemotherapy is only given to patients who benefit from it.

The result report shows the patient’s individual absolute benefit of chemotherapy with current treatment regimens on a continuous curve.

Absolute chemotherapy benefit at 10 years for patients with 5 years of endocrine therapy alone versus chemotherapy plus 5 years of endocrine therapy
EndoPredict is the only test with validation of chemotherapy benefit in a study with more than 3,700 pre- and postmenopausal patients.

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;176:377-386

Risk Up To 15 Years – Your Patient's Long Term Confidence

EndoPredict is the only gene expression test that indicates the recurrence risk up to 15 years and therefore the most beneficial test to decide for or against an extended endocrine therapy.

The result report indicates the patient’s individual distant recurrence risk within years 5-15 on a continuous curve.

Likelihood of late distant recurrence within years 5-15 for patients with no recurrence after 5 years of endocrine therapy alone

Long term prognosis is validated in 1,386 patients with ER+, HER2-, node negative or node positive breast cancer.

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;25:3865-3872

EndoPredict In Direct Comparison

EndoPredict Predicts The Real Risk Of Patients

In the TransATAC study, the prognostic abilities of EndoPredict (EPclin Risk Score) and Oncotype DX (RS) were compared head-to-head in 928 patients treated with 5 years endocrine therapy alone. Primary endpoint was 10 year distant recurrence free survival.

Analysis of the 28% discordantly classified patients showed superior accuracy of EndoPredict.

Results of a concordance analysis between EPclin Risk Score and RS


The classification by EndoPredict 
aligns
more closely
 with patient outcomes.

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 Jul 10;108(11)

EndoPredict Identifies More Patients As True Low Risk

The TransATAC study also compared the performance of additional commercially available prognostic signatures for breast cancer in 774 patients treated with 5 years endocrine therapy alone. Primary endpoint was distant recurrence free survival.

In node negative patients the recurrence rate (DR) in years 0-10 of the low risk groups was comparable, but EndoPredict identified most patients as low risk. In node positive patients two signatures were not able to identify low risk patients at all. Among the other two signatures EndoPredict identified more patients as low-risk.

Percentage of low risk  patients and  recurrence rate in node negative and node positive patients  from TransATAC

With EndoPredict, more patients
can safely avoid chemotherapy.

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;4(4):545-553