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Breast Cancer


EndoPredict® for breast cancer is an in vitro multi-gene prognostic test that provides highly important and clear information for different stages of treatment planning for patients with estrogen receptor positive, HER2-negative, primary breast cancer.

It helps to define the risk of breast cancer recurrence, the benefits of chemotherapy and who can benefit from extended endocrine therapy.

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 years 6 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. EndoPredict is performed on FFPE tumour tissue from biopsy or surgical specimens. 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.

Molecular Assays in Breast Cancer

Breast cancer patients and their treating doctors must make complex, highly personalised treatment decisions. Prognostic tools, such as EndoPredict, can play a vital role in determining the type of treatment and prognosis for the patient through assisting with adjuvant therapy decision making in ER positive breast cancer.

Studies of gene expression conducted in the early 2000s highlighted the potential of molecular assays to provide additional information beyond traditional pathology about prognosis. These assays have all been shown to provide useful prognostic information to ER-positive patients about their risk of developing breast cancer recurrence and their use is supported by international guidelines.

A number of studies have shown that the second-generation assays such as EndoPredict (provided by Clinical Labs), which also incorporate clinical variables such as lymph node status and tumour size, are better able to predict late recurrence (5–15 years post treatment) and may also identify a larger group of low-risk patients 3,4.

High quality pathology is a vital part of breast cancer diagnosis and management, and molecular assays such as EndoPredict can provide important additional information to support complex decision making about the use of chemotherapy in ER-positive breast cancer.

EndoPredict at a Glance

  • Only prognostic test that can answer
    - whether your patient can safely avoid chemotherapy
    - how beneficial chemotherapy would be
    - whether your patient can avoid extended endocrine therapy
  • Largest “true” low risk group for safe reduction of chemotherapy
    - more than 70% of N0 patients
    - up to 30% of N+ patients
  • Second generation gene expression test for superior prognostic power
  • Unique gene selection for accurate early and late risk assessment
  • Consistent study cohorts and constant cut-off
  • Clear low- and high-risk category
  • Rapid results

Target group check

ER-positive 0-3 pos. lymph node Size: pT1-3
HER2/neu-negative Pre-/post-menopausal  

How to Order: Fill out our Somatic Mutation Testing/EndoPredict request form and tick EndoPredict.
Turnaround Time: 4–5 business days from the sample receipt date.
Specimen Required: Formalin-fixed paraffin-embedded (FFPE) tissue of a solid breast cancer tumour.
Test Cost: Partial Medicare rebate coming soon. Currently an out-of-pocket fee of $2980 applies.

For further information, or to enquire about ordering EndoPredict, please contact Australian Clinical Labs Molecular department on (03) 9538 2259.

1. Filipits M et al. (2011) Clin Cancer Res, 17(18):6012–6020.
2. Dubsky P. et al. (2013) Ann Oncol, 24:640–647.
3. Buus et al. (2016) J Natl Cancer Inst, 108:11pp.
4. Sestak I et al. (2018) JAM Oncology Published online February 15, 2018.
5. Martin M et al.: BCR, 16:R3.
6. Sestak I et al. (2018) SABCS 2018.
7. Filipits M et al. (2018) SABCS 2018.
8. Dubsky P et al.: The EndoPredict score provides prognostic information on late distant metastases in ER+/HER2- breast cancer patients. BJC.

Download EndoPredict Expanded Brochure Download EndoPredict Summary Brochure
Download EndoPredict Request FormDownload EndoPredict Request Form (WA)
Download EndoPredict Patient Brochure

Somatic Mutation | Solid Tissue Molecular Profiling in Breast Cancer 

Next generation sequencing studies have drawn the general landscape of breast cancers and identified hundreds of new, actual therapeutic targets. Two major signalling pathways seem to be altered in a vast proportion of breast cancers 1,2. The PI3K/AKT pathway is activated and the JUN/MAPK pathway is repressed. Via the regulation of the cell cycle, this metabolic switch impacts on the balance between self-renewal, proliferation and differentiation of the tumour-initiating cells.

Inhibiting the PI3K/AKT pathway appears as a paramount strategy to stop tumour growth. In breast cancer, somatic PIK3CA mutations occur in ~25% of cases. As such, mutated PI3K has become an attractive therapeutic target in breast cancer therapy and a number of agents targeting the PIK pathway are currently in clinical development 3,4.

PI3K is involved in downstream signalling from several clinically relevant membrane receptors such as HER2 (ERBB2) and epidermal growth factor receptor (EGFR). Identifying an overexpression of the ERBB2 gene can determine the response to ERBB targeted inhibitors 5,6.

Breast Cancer Solid Tissue Gene Panel

Genes sequenced in this panel include:


When to Order: At diagnosis.
How to Order: Fill out our Somatic Mutation testing request form and tick the Somatic Mutation test panel required.
Turnaround Time: 5–7 business days from the sample receipt date.
Specimen Required: Fresh formalin-fixed paraffin-embedded (FFPE) of 5-10 μm thickness from the tumour tissue. 
Test Cost: No Medicare rebate available. An out-of-pocket fee of $400 applies.

A negative result does not rule out the presence of a mutation that may be present but below the limits of detection for this assay (<1%).

1. The Cancer Genome Atlas Network: Comprehensive molecular portraits of human breast tumours. Nature 2012, 490:61–70.
2. Shah P, et al., (2012) Nature 2012, 486:385–399.
3. Lee JW, et al., (2005) Oncogene 24(8):1477–1480.
4. Levine DA, (2005) Clin Cancer Res 11(8):2875–2878.
5. Birnbaum D, et al., (2009) Cancer Cell Int 9:5.
6. Hynes N & MacDonald G (2009). Curr Op Cell Biol 21:177–184.

Download Somatic Mutation Brochure

Download Somatic Mutation Request Form Download Somatic Mutation Request Form - WA

The content on our Molecular Cancer Services page is written by Associate Professor Mirette Saad, National Director of Molecular Genetics at Australian Clinical Labs.


Assoc. Prof. Mirette Saad

Lab: Clayton
Speciality: Chemical Pathology and Molecular Genetics
Areas Of Interest: Cancer Genetics, Antenatal Screening, NIPT, Endocrine, Fertility Testing and Research, Medical Teaching
Phone: 1300 134 111
Email: mirette.saad@clinicallabs.com.au

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 Suez Canal University, Egypt. 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 non-invasive prenatal testing (NIPT), antenatal screening, personalised drug therapy and cancer.

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