Pathologists & Labs

EndoPredict® Breast Cancer Prognostic test is a second generation gene expression breast cancer recurrence test available for local pathology labs to perform, allowing clinicians fast access to results. Our pathology lab partners offer EndoPredict across the world.

Clinicians trust EndoPredict to detect risk of recurrence for ER positive/HER2 negative early-stage breast cancer

The EndoPredict second generation test gives clinicians individualized results for all eligible women with early-stage breast cancer to help them make confident treatment decisions about chemotherapy and long-term hormone therapy. Clinicians trust EndoPredict for its accurate prognostic and predictive performance.

EndoPredict is a CE-marked in vitro diagnostic (IVD) multiparameter gene expression test for breast cancer. It can be performed in local molecular pathology laboratories in many countries or ordered by clinicians from Myriad Genetics’ central laboratory in Salt Lake City, USA.

Results are available within a few days, allowing safe treatment decisions to be made quickly for the benefit of each woman with ER positive/HER2 negative early-stage breast cancer. The medium hands-on time takes just 2.5 hours, leading to a complete turnaround time of about 8 hours.

Generate the EndoPredict report

Our existing lab partners can upload their sample data and generate the EndoPredict result report here.

EndoPredict is locally reproducible

The EndoPredict gene expression test can be easily and accurately replicated, consistently delivering the same quality of results regardless of pathology lab.1

Test performance was evaluated in seven different molecular pathology labs across Germany, Austria and Switzerland:

  • The variance and accuracy of the EndoPredict assays were determined using predefined reference values
  • The EPclin Risk Scores measured by individual participants showed exceptional correlation with reference values – mean value of Pearson correlation coefficients, r= 0.996
  • All samples were assigned to the correct EPclin risk group, resulting in a sensitivity and specificity of 100%, a concordance of 100%, and a kappa of 1.0
  • Similar results have also been shown in a French round-robin trial.

EndoPredict consistently delivers precise results in a decentralized setting.

Superior accuracy

EndoPredict is the most accurate prognostic test for breast cancer distant recurrence.2

The test has been developed and validated to include genes that predict both early and late metastasis.3-5 These improve prognostic power of EndoPredict compared with first generation tests, like Oncotype DX and MammaPrint. 2

Learn more about EndoPredict’s superior accuracy

How to perform the EndoPredict test

  • Sampling

    • The test is performed on FFPE tumor tissue from biopsy or surgical specimens. Either a tumor block or slides are suitable
    • The tumor should represent at least 30% of the sample

  • RNA isolation

    • Can be performed manually or automatically, with a turnaround time of 3 hours per 12 samples

  • Analysis

    • RT-qPCR can be run on one of three different PCR platforms (VERSANT kPCR [Siemens Healthcare]; QuantStudio DX [Thermo Fisher]; QuantStudio 5 DX [Thermo Fisher])
    • Up to 4 samples can be run with one PCR instrument with the total laboratory time less than 8 hours, or up to 12 samples in 2 days

  • Result

    • The result report (including quality control) is generated using a web-based software – see the EndoPredict report generator below
    • A report is generated in less than 15 minutes

How to generate an EndoPredict report

  1. Upload text file – to generate the report from the expression levels of the eight disease-relevant genes and four reference and normalization genes in the tumor sample, upload an export file from the PCR-platform to the EndoPredict Report Generator (EPRG).
  2. Reagent lot numbers – verify the lot numbers entered into the PCR-Software
  3. Sample data – enter patient data, including tumor size, nodal status and any remarks

Try it by generating an example test report below.

Get the EndoPredict test in your lab

EndoPredict is available as a CE-marked IVD kit that can be run in local molecular pathology laboratories after a comprehensive onsite training, provided by Myriad Genetics.

References

  1. Denkert, Carsten et al. “Decentral Gene Expression Analysis For ER+/Her2− Breast Cancer: Results Of A Proficiency Testing Program For The Endopredict Assay“. Virchows Archiv, vol 460, no. 3, 2012, pp. 251-259
  2. Sestak, Ivana et al. “Comparison Of The Performance Of 6 Prognostic Signatures For Estrogen Receptor–Positive Breast Cancer“. JAMA Oncology, vol 4, no. 4, 2018, pp. 545-553
  3. Dubsky, Peter et al. “The Endopredict Score Provides Prognostic Information On Late Distant Metastases In ER+/HER2− Breast Cancer Patients“. British Journal Of Cancer, vol 109, no. 12, 2013, pp. 2959-2964
  4. Filipits, Martin et al. “A New Molecular Predictor Of Distant Recurrence In ER-Positive, HER2-Negative Breast Cancer Adds Independent Information To Conventional Clinical Risk Factors“. Clinical Cancer Research, vol 17, no. 18, 2011, pp. 6012-6020
  5. Filipits, Martin et al. “Prediction Of Distant Recurrence Using Endopredict Among Women With ER+, HER2− Node-Positive And Node-Negative Breast Cancer Treated With Endocrine Therapy Only“. Clinical Cancer Research, vol 25, no. 13, 2019, pp. 3865-3872