EndoPredict is a second generation gene expression assay for pre- and postmenopausal women with ER positive, HER2 negative early-stage breast cancer that is lymph node positive or negative – and the only second generation test with level of evidence 1A data.5
As a second generation test, EndoPredict combines three factors – a molecular gene expression score, tumor size and nodal status – to give the EPclin Risk Score. The result is more prognostic power than first generation breast cancer recurrence tests that only measure gene expression.
The test has been developed and validated to include genes that predict both early and late metastasis. This focus on ER-related genes in addition to proliferative genes improves the unique prognostic power of EndoPredict compared with classical prognostic factors and first generation tests, like the Oncotype DX® test or MammaPrint®.
EndoPredict is also the only second generation test with a clear classification into low-risk and high-risk groups, and has a reliable cut-off value that has never changed.
EndoPredict vs Oncotype DX® and other commercially available tests.
The TransATAC study compared the performance of four commercially available prognostic signatures for breast cancer distant recurrence, including first and second generation tests. The study included 774 patients treated with endocrine therapy alone for 5 years.1
The C-index is a statistical tool used to evaluate the accuracy of an algorithm and therefore the prognostic power of a test by comparing predicted outcomes with actual events. A high C-index indicates results cannot be chance (as in the flip of a coin which is chance and scores 0.5) but are due to the accuracy of the test. Results are independent of test cut-off values.
The EndoPredict test aligns more closely with observed risk.4
Study details (TransATAC concordance analysis):
Read clinical summary
Compared to risk stratification using only clinical parameters or other gene expression tests, EndoPredict identifies a large group of true low-risk breast cancer patients who could avoid chemotherapy.1,4,19 Learn more about this comparison study here.
In node positive patients, EndoPredict was one of the two signatures that identified patients with true low-risk of distant recurrence (<10%).
Learn more about EndoPredict in node positive patients.
In all validation studies of ER positive, HER2 negative, node positive and node negative patients, EndoPredict identified a large low-risk group with a recurrence risk of less than 10%, regardless of whether the patients were pre- or postmenopausal.2-4,11,19-21
Initial results from a randomized controlled prospective phase III study (UNIRAD) released at SABCS 2021 prospectively confirm the validation studies.22
A prospective French registry (SiMoSein) including more than 4,700 patients emphasizes the clinical need for gene expression testing to avoid over and under treatment, as presented at ESMO 2021.23
Studies show that regardless of nodal status, EndoPredict detects premenopausal patients who are at true low-risk that may safely avoid chemotherapy.22,24
EndoPredict illuminates the right treatment pathway for every woman, regardless of nodal status or number of positive lymph nodes.
EndoPredict Breast Cancer Prognostic Test is available to order by clinicians via numerous local labs in your country or outside of the EU also via Myriad Genetics’ central laboratory in Salt Lake City, USA.