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What is EndoPredict?
Leading Prognostic in Europe Available in the US
EndoPredict is a next-generation breast cancer recurrence test that integrates tumor biology and pathology to accurately predict early and late (5-15 years) recurrence with an individualized absolute chemotherapy benefit.1-3
EndoPredict is the Only Test to Answer Three Critical Questions:
1. What is the 10-year Risk of Breast Cancer Coming Back?
2. What is the Patient’s Individualized Benefit from Chemotherapy?
3. Who is Unlikely to Benefit from Extended Endocrine Therapy?
EndoPredict provides accurate results for patients diagnosed with ER+, HER2− early-stage breast cancer with either node-negative or node-positive disease (1- 3 nodes)3-5
EndoPredict accurately identifies patients who have a low risk of their breast cancer coming back and may be able to safely forego chemotherapy3,4
The test combines a 12-gene molecular score (tumor biology) with tumor size and nodal status (tumor pathology), significantly improving prognostic performance4 over the leading competitor
EndoPredict provides a binary (low/high) result that is also individualized for each patient based on their tumor’s biology and pathology.
The utilization of proliferation and hormone-receptor genes leads to accurate assessment of early and late recurrence risk3,8

References: 1.Filipits M, Dubsky P, Rudas M, et al. Prediction of distant recurrence using EndoPredict among women with ER‑positive, HER2-negative breast cancer with a maximum follow-up of 16 years. Poster presented at: 41st Annual San Antonio Breast Symposium; December 5-9, 2018, San Antonio, TX. 2. Sestak I, Martín M, Dubsky P, 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. [published online ahead of print April 30, 2019]. https://doi.org/10.1007/s10549-019-05226-8. 3. Filipits M, Rudas M, Jakesz R, et al; for EP Investigators. 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. 4. Buus R, Sestak I, Kronenwett 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;108(11): doi: 10.1093/jnci/djw149. 5. Martin M, Brase JC, Calvo L, et al. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014;16(2):R38. doi: 10.1186/bcr3642. 6. Dubsky P, Brase J, Jakesz R, et al; on behalf of Austrian Breast and Colorectal Cancer Study Group. The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2− breast cancer patients. Br J Cancer. 2013;109(12):2959-2964.
Providing 3 clinical answers to inform breast cancer treatment decisions
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Commercially available for nearly 10 years and recognized as safe and cost-effective for patient care.
The leading breast cancer recurrence test in Europe and included in prominent international guidelines (NCCN1, ASCO2, ESMO3, St. Gallen4, NICE5).
Through the integration of tumor biology and pathology, EndoPredict provides a more accurate individualized high or low risk prognosis in both node-negative and node-positive disease than the leading competitor.6
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EndoPredict now offers an individualized chemotherapy benefit to help physicians and patients decide whether adding chemotherapy is worth it.7
This chemotherapy benefit was validated in over 3,700 patients with ER+, HER2- breast cancer and with modern (taxane-containing) treatment regimens.
While patients with a low-risk EndoPredict result did not benefit from the addition of chemotherapy, those with a higher EndoPredict score had a greater benefit from chemotherapy.
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The only prognostic test that provides recurrence risk out to 15 years to help guide extended endocrine treatment decisions.8
Validated in more than 1,300 patients with node-negative or node-positive disease, who had not recurred within 5 years of diagnosis, EndoPredict was highly prognostic in years 5‑15 for patients treated with 5 years of endocrine therapy alone.
Patients classified by EndoPredict as low risk had an average rate of recurrence of 4% in years 5‑15. As a result, these patients were unlikely to benefit from extended endocrine therapy.
Women with low EndoPredict scores had significantly better long-term outcomes than patients with high EndoPredict scores.
References: 1. National Comprehensive Cancer Network. Breast Cancer (Version 2.2018) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed October 18, 2018. 2. Harris LN, Ismaila N, McShane LM, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2016;34(10):1134-1150. 3. Senkus E, Kyriadkides S, Ohno S, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26 Suppl 5:v8-v30. 4. Curigliano G, Burstein H, Winer E, et al; De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017;28(8):1700‑1712. 5. National Institute for Health and Care Excellence. Tumor profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. http://nice.org.uk/guidance/dg34. Accessed February 26, 2019. 6. Buus R, Sestak I, Kronenwett 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;108(11): doi: 10.1093/jnci/djw149. 7. Sestak I, Martín M, Dubsky P, 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. [published online ahead of print April 30, 2019]. https://doi.org/10.1007/s10549-019-05226-8. 8. Filipits M, Dubsky P, Rudas M, et al. Prediction of distant recurrence using EndoPredict among women with ER‑positive, HER2-negative breast cancer with a maximum follow-up of 16 years. Poster presented at: 41st Annual San Antonio Breast Symposium; December 5-9, 2018, San Antonio, TX.
The EndoPredict Risk Score
EndoPredict provides a comprehensive test result and an individualized EndoPredict Risk Score. The EndoPredict Risk Score integrates a 12-gene molecular score with the highly prognostic factors tumor size and nodal status.1,2,3 

 

This novel approach provides a consistent, accurate risk assessment rigorously proven through independent clinical studies.1,2

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12-gene
Molecular Score

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Tumor Size
and Nodal Status

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12-Gene Molecular Score
The 12-Gene Molecular Score independently assesses risk of recurrence based upon quantitative reverse transcription polymerase chain reaction (qRT-PCR) of 8 signature genes, 3 normalization genes, and 1 control gene.
The 12-Gene Molecular Score includes genes that predict both early and late metastasis to provide improved prognostic power.
12-Gene Molecular Score
The 12-Gene Molecular Score significantly improved prognostic performance when added to the following measures:
Nodal status, tumor size, age, and grade
Quantitative ER levels
Quantitative Ki-67 levels
Adjuvant! Online

Tumor Size and Nodal Status
Tumor size and nodal status are established prognostic markers routinely used to stage invasive breast cancer.4 Both clinicopathological factors independently contribute significant prognostic information. The integration of the 12‑Gene Molecular Score with tumor size and lymph node status (EPclin) resulted in a statistically significant improvement in prognostic power above the clinicopathological factors alone.1
 
Tumor Size
Nodal Status
 
EndoPredict offers a clear low- or high-risk result presented on a continuous curve – providing an individualized risk of distant recurrence for each patient.
 
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View a Sample Report

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Clinically validated
in multiple cohorts

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References: 1.Filipits M, Rudas M, Jakesz R, et al. A new molecular predictor of distant recurrence in ER‑positive, HER2-negative breast cancer adds independent prognostics information to conventional clinical risk factors. Clin Cancer Res. 2011;17(18)6012-6020. 2. Sestak I, Buus R, Cuzick J, 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. 3. Pan H, Gray R, Braybrooke J, et al. 20-year risk for breast-cancer recurrence after stopping endocrine therapy at 5 years. N Eng J Med. 2017; 377:1836-1846. 4. Hortobagyi G, Connolly J, D’Orsi C, et al. AJCC Cancer Staging Manual, 8th Ed. New York: Springer; 2017.
EndoPredict vs. The Competition
How is EndoPredict Different?
EndoPredict vs. The Competition
According to Simon, Hayes and Paik:
Studies using archived tissue from prospective studies meet Level 1 evidence when “the results are validated in at least one or more similarly designed studies using the same assay technique.”15
 
EndoPredict is easy for physicians to use and for patients to access
Lower cost vs other breast cancer recurrence tests
Lower cost vs other breast
cancer recurrence tests
Fast 7-day turnaround
Fast 7-day turnaround
Easy-to-understand report
Easy-to-understand report
 
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References: 1. Sestak I, Martín M, Dubsky P, 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. [published online ahead of print April 30,2019]. https://doi.org/10.1007/s10549-019-05226-8. 2. Paik S, Tang G, Shak S, et al; Gene Expression and Benefit of Chemotherapy in Women with Node-Negative, Estrogen Receptor-Positive Breast Cancer. J Clin Oncol 2006; 24:3726-3734. 3. Albain K, Barlow W, Shak S, et al; Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial. Lancet Oncol 2010;11:55-65. 4. Filipits M, Rudas M, Jakesz R, et al; for EP Investigators. 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. 5. Paik S, Shak S, Tang G, et al; A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer. N Engl J Med 2004; 351:2817-26. 6. van’t Veer L, Dai H, van de Vijver M, et al; Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002;415:530-6. 7. Jerevall P, Ma X, Li H, et al; Prognostic utility of HOXB13:IL17BR and molecular grade index in early-stage breast cancer patients from the Stockholm trial. Br J Cancer 2011;104:1762-1769. 8. Wallden B, Storhoff J, Nielsen T, et al; Development and verification of the PAM50-based Prosigna breast cancer gene signature assay. BMC Medical Genomics 2015; 8:54. 9. National Comprehensive Cancer Network. Breast Cancer (Version 2.2018) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed October 18, 2018. 10. Harris LN, Ismaila N, McShane LM, et al. Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2016;34(10):1134-1150. 11. Curigliano G, Burstein H, Winer E, et al; De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer. Ann Oncol 2017;28:1700-1712. 12. Senkus E, Kyriakides S, Ohno S, et al; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2015;26(Suppl 5):v8-v30. 13. National Institute for Health and Care Excellence. Tumor profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. http://nice.org.uk/guidance/dg34. Accessed February 26, 2019. 14. Krop I, Ismaila N, Andre A, et al; Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. J Clin Oncol 35:2838-2847. 15. Simon R, Paik S, Hayes D; Use of Archived Specimens in Evaluations of Prognostic and Predictive Biomarkers. J Natl Cancer Inst 2009;101:1446-1452.
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