EndoPredict breast cancer testing


EndoPredict predicts the real risk of patients

Head-to-Head Comparison

Decisions on the use of adjuvant chemotherapy in ER+, HER2- primary breast cancer are guided by the risk of distant recurrence. EndoPredict® and Oncotype DX® are prognostic gene expression tests used for estimating distant recurrence risk. EndoPredict provides prognostic information from a molecular signature (12-Gene Molecular Score) combined with tumor size and nodal status (EPclin Risk Score). Oncotype DX provides prognostic information from a molecular signature only (Recurrence Score RS).

In the TransATAC study, the prognostic abilities of the EPclin Risk Score, the 12-Gene Molecular Score and RS were compared in a head-to-head analysis. A total of 928 patients treated with 5 years of endocrine therapy only (Tamoxifen or Anastrazole) were included. The primary endpoint was 10 year distant recurrence free survival (DRFS).

EndoPredict Predicts the Risk of Patients Most Accurately

378 (28%) of patients were classified discordantly by the two tests. Analysis of the discordantly classified patients showed superior accuracy of EndoPredict. The classification by EndoPredict aligns more closely with patient outcomes.

Discordance analysis between EndoPredict® (EPclin) and Oncotype DX® (RS) in TransATAC

RS miscategorized 261 of the patients. This leads to 117 patients (dark green line) having possibly been overtreated based on RS and 144 patients (light blue line) having possibly been undertreated based on RS.

Low Risk Results you can Trust In Node Negative AND Node Positive Patients

In all analyses, EndoPredict was highly prognostic for all patients and in all subgroups.

In node negative patients, EndoPredict identified a larger low risk group than RS. In node positive patients only, EndoPredict was able to identify true low risk patients. The RS low risk group showed a 10 year recurrence rate of 25%. 

EndoPredict identified 9% more node negative patients at low risk than RS with excellent outcomes at 10 years.
EndoPredict identified node positive low risk patients with a 10 year recurrence rate of 5%. Recurrence rate in the RS low risk group was 5 times higher.
Analysis of ER+, HER2- patients from both ABCSG-6 and ABCSG-8

EndoPredict has the Strongest Prognostic Accuracy

The prognostic accuracy of the two tests was compared using the standard statistic χ2.

The EPclin Risk Score shows stronger predictive power than RS in all follow-up periods. The 12-Gene Molecular Score alone clearly outperforms RS in years 0-10 and 5-10 (late metastasis).

Comparison of the prognostic power of a second generation test (EndoPredict®) with that of a first generation test (OncotypeDx®) 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.

EndoPredict provides more prognostic information for two important reasons: integration of clinicopathological factors (nodal status and tumor size) and a superior molecular component able to predict late events more accurately.

In conclusion, the data demonstrates that the 12-Gene Molecular Score and the EPclin Risk Score do have increased prognostic ability and greater accuracy than Oncotype DX, the leading first generation test.

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)