EndoPredict
An advanced gene expression test for predicting the risk of distant recurrence in early-stage primary breast cancer.
EndoPredict, available at Clinical Labs, is the only prognostic test that provides insights into the risk of breast cancer recurrence, the benefits of chemotherapy and the suitability for extended endocrine therapy in women with ER+, HER2- primary breast cancer.
EndoPredict is a second-generation gene expression test for superior prognostic power and is now partially Medicare rebatable.
| Target group check | ||
|---|---|---|
| HER2 negative | Lymph node positive or negative | Tumour size pT1 to pT3 |
| ER positive | Pre- and postmenopausa | Grade 1 to 3 |
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Why choose EndoPredict?
- EndoPredict is trusted in global clinical routine and is recommended by all major
guidelines:
- European Society of Medical Oncology (ESMO) 2024
- American Society of Clinical Oncology (ASCO) 2022
- Gallen International Expert Consensus 2023
- American Joint Committee on Cancer (AJCC) 2017
- National Comprehensive Cancer Network (NCCN) 2024
- National Institute for Health and Care Excellence (NICE) 2024
- Performed locally in Australia and partially Medicare rebatable:
- EndoPredict is performed locally in Australia only through Clinical Labs - with a rapid turnaround time of 4-5 business days.
- Largest “true” low risk group for safe reduction of chemotherapy:
- More than 70% of N0 patients
- Up to 30% of N+ patients
- Consistent study cohorts and constant cutoff
- Unique gene selection for accurate early and late risk assessment
- Clear low and high-risk category
- EndoPredict is trusted in global clinical routine and is recommended by all major
guidelines:
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What does EndoPredict report?
EndoPredict provides a comprehensive test result and an individualised EPclin Risk Score. The EPclin Risk Score algorithm integrates a 12-gene molecular score, tumour size, and nodal status. All three factors contributed significant information with respect to risk assessment in an independent clinical validation study.1 In addition to the percentage risk of recurrence up to 10 years, the absolute chemotherapy benefit based on current treatment regimens and the risk of recurrence between 5 and 15 years after diagnosis* is indicated. The patient is classified as “low risk” or “high risk”. The treating physician receives the report and can plan further treatment based on the results.
Under endocrine therapy alone without chemotherapy, more than 95% of low-risk patients do not experience a distant recurrence, even more than 10 years after diagnosis.1 Compared to risk stratification using other gene expression tests or clinical parameters, EndoPredict identifies the largest group of women with breast cancer at low risk (<10% chance of distant recurrence in 10 years) who might safely avoid chemotherapy.2,3,4 In addition EndoPredict predicts the individual absolute chemotherapy benefit at 10 years5 and is the only test that provides the individual risk of breast cancer late distant recurrence within years 5-15 to help in deciding whether a patient can avoid extended endocrine therapy.
*5-15 year risk is based on treatment with 5 years of endocrine therapy only – no chemotherapy. The result assumes the patient has not experienced recurrence by 5 years.
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When to use EndoPredict?
EndoPredict is performed on FFPE tumour tissue from biopsy or surgical specimens from patients who have not received systemic endocrine therapy and/or chemotherapy. The 12-gene molecular score (also called EP Score in publications) is determined initially. As soon as information on tumour size and nodal status is available, it is combined with the 12-gene molecular score to calculate the EPclin Risk Score.
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How to Order EndoPredict
Request Form Instructions:Please download the EndoPredict request form, fill in the patient details and clinical history, select “EndoPredict,” and indicate whether the patient meets the Medicare Eligibility Criteria.
Ensure that referring clinician details are complete, and if known, provide specimen details. If you would like a copy of the report to be sent to another clinician, please provide the necessary details.
Specimens Required:EndoPredict is performed on FFPE tumour tissue from biopsy or surgical specimens.
Test Cost:The total out-of-pocket cost for Clinical Labs’ EndoPredict test is $1,173.70.
Patients pay $2,275 upfront and can then claim back a partial rebate of $1,101.30 directly from Medicare (eligibility criteria apply).
Patients are required to pay for EndoPredict prior to our laboratory conducting the test. Clinical Labs will contact your patient via SMS or phone call with payment instructions—please advise them to expect this communication in the days following the test request. After making the payment online, Clinical Labs will send your patient a receipt, which they can use to claim the partial Medicare rebate directly from Medicare.
Medicare Eligibility Criteria:Gene expression profiling testing using EndoPredict, for the purpose of profiling gene expression in formalin‑fixed, paraffin‑embedded primary breast cancer tissue from core needle biopsy or surgical tumour sample to estimate the risk of distant recurrence of breast cancer within 10 years, if:
(a) the sample is from a new primary breast cancer, which is suitable for adjuvant chemotherapy; and
(b) the sample has been determined to be oestrogen receptor positive and HER2 negative by IHC and ISH respectively on surgically removed tumour; and
(c) the sample is axillary node negative or positive (up to 3 nodes) with a tumour size of at least 1 cm and no more than 5 cm determined by histopathology on surgically removed tumour; and
(d) the sample has no evidence of distal metastasis; and
(e) pre‑testing of intermediate risk of distant metastases has shown that the tumour is defined by at least one of the following characteristics: (i) histopathological grade 2 or 3; (ii) one to 3 lymph nodes involved in metastatic disease (including micrometastases but not isolated tumour cells); and
(f) the service is not administered for the purpose of altering treatment decisions Applicable once per new primary breast cancer diagnosis for any particular patient.
Turnaround Time:4–5 business days from the sample receipt date.
References
- Filipits M et al. (2011) Clin Cancer Res, 17(18):6012–6020.
- Dubsky P. et al. (2013) Ann Oncol, 24:640–647.
- Buus et al. (2016) J Natl Cancer Inst, 108:11pp.
- Sestak I et al. (2018) JAM Oncology Published online February 15, 2018.
- Sestak I et al. (2018) SABCS 2018.
About the Author
Associate Professor Mirette Saad
MBBS(Hons) MD(Hons) MAACB FRCPA PhDAssociate Professor Mirette Saad
MBBS(Hons) MD(Hons) MAACB FRCPA PhD- antenatal screening
- cancer genetics
- clinical research and medical teaching
- endocrine
- fertility testing
- molecular genetics
- nipt
- precision medicine
Associate Professor Mirette Saad is a Consultant Chemical Pathologist and the National Director of Molecular Genetics at Australian Clinical Labs. She has a Fellowship with honours in Chemical and Molecular Pathology, with Microbiology sub-speciality, from overseas. A/P Saad received her NHMRC sponsored PhD degree in Cancer Genetics from Melbourne University and Peter MacCallum Cancer Institute. Along with her teaching and research roles, A/P Saad is a registered medical practitioner with AHPRA, a Chemical Pathology Fellow (FRCPA) at the Royal College of Pathologists of Australasia and a Member of the Australasian Association of Clinical Biochemists (MAACB). She is a Chair of the RCPA Chemical Pathology Advisory Committee, Member of the RCPA Genetic Advisory Committee, AACB and a Chair of the Precision Medicine Services at Australian Clinical Labs. At Clinical Labs, A/Prof Mirette Saad leads the Molecular Genetic testing for NIPT, antenatal screening, personalised drug therapy and cancer.
Related Pages
EndoPredict® for breast cancer treatment
Associate Professor Mirette Saad outlines how EndoPredict supports personalised treatment decisions in ER positive, HER2 negative breast cancer.
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