What is Endopedict?

EndoPredict: A Genomic Test for Breast Cancer Treatment Decisions

EndoPredict is a 12-gene molecular assay used to guide decisions on adjuvant systemic chemotherapy in patients with estrogen receptor (ER)/progesterone receptor (PgR)-positive, HER2-negative early breast cancer. This test helps identify patients who may safely avoid chemotherapy based on their risk of recurrence.

Clinical Applications and Evidence

• EndoPredict provides a risk score that helps determine which patients with ER/PgR-positive, HER2-negative breast cancer might benefit from adjuvant chemotherapy versus those who can safely avoid it 1
• The test is specifically validated for use in node-negative breast cancer, where it has demonstrated ability to identify patients with good outcomes on endocrine therapy alone at 10 years of follow-up 1
• EndoPredict has been granted a Level of Evidence rating of "intermediate" with a "moderate" strength of recommendation by the American Society of Clinical Oncology (ASCO) for guiding chemotherapy decisions in node-negative disease 1
• The test should not be used for patients with node-positive disease, HER2-positive breast cancer, or triple-negative breast cancer according to ASCO guidelines 1

Technical Details

• EndoPredict analyzes the expression of 12 genes in formalin-fixed, paraffin-embedded (FFPE) tumor tissue using reverse transcription-quantitative real-time PCR (RT-qPCR) 2
• The test provides both a molecular score and a combined clinical-molecular score (EPclin) that incorporates tumor size and nodal status 3
• EndoPredict has demonstrated high analytical validity with good precision and minimal laboratory-to-laboratory variation, making it suitable for decentralized testing in specialized molecular pathology laboratories 2

Clinical Outcomes

• Recent long-term prospective outcome data show that EndoPredict effectively stratifies patients into low and high risk groups, with EPclin high-risk patients having a twofold higher risk for disease recurrence or death compared to EPclin low-risk patients 4
• EPclin low-risk patients had a 5-year disease-free survival of 95.3%, demonstrating excellent outcomes with endocrine therapy alone 4
• High-risk patients who received chemotherapy showed significantly better outcomes (5-year DFS of 89.1%) compared to high-risk patients who did not receive chemotherapy (68.9%) 4

Comparison to Other Genomic Tests

• EndoPredict is one of several gene expression assays recommended by ESMO guidelines for use in early breast cancer, alongside MammaPrint, Oncotype DX, and Prosigna 1
• Like other genomic tests, EndoPredict helps determine individual recurrence risk and potentially predict chemotherapy benefit 1
• Unlike some other tests, EndoPredict has demonstrated prognostic value for both early (0-5 years) and late (5-10 years) distant recurrence 3

Limitations and Caveats

• EndoPredict should not be used for treatment decisions in patients with HER2-positive breast cancer or triple-negative breast cancer 1
• The test is currently not recommended for guiding treatment decisions in node-positive disease, though some emerging data suggests potential utility in this population 4, 3
• As with all genomic tests, results should be interpreted in conjunction with other clinicopathological factors for optimal treatment decision-making 1

Practical Application

• For patients with ER/PgR-positive, HER2-negative, node-negative breast cancer, EndoPredict can help identify those who may safely avoid chemotherapy 1
• The test appears to be effective in both pre- and postmenopausal women, with recent data confirming its prognostic value regardless of menopausal status 4
• EndoPredict results should be discussed in a multidisciplinary setting, integrating the genomic information with traditional clinicopathological factors 1