EndoPredict

Eurobio Scientific presents the test for women diagnosed with early invasive primary ER+ / HER2− breast cancer. It may be used before and after menopause.

The clinician information specifies ductal or lobular tumours, pT1–pT3 size categories and grades 1–3. The test is recommended when lymph nodes are negative or no more than three are involved. These conditions must not be extended to all breast cancer cases.

• Eurobio Scientific: eligibility criteria for clinicians

EndoPredict analyses tumour gene expression. The manufacturer’s molecular score based on 12 genes is combined with tumour size and nodal status to calculate the EPclin risk score.

This test describes the biology and prognosis of an already diagnosed tumour. It is not intended to determine hereditary cancer risk from family history alone.

• How the EndoPredict result is calculated

The official explanation of results distinguishes three related but different types of information:

• Distant recurrence risk over years 0–10 with five years of endocrine therapy.
• Estimated additional absolute chemotherapy benefit over 10 years, comparing chemotherapy plus endocrine therapy with endocrine therapy alone.
• Late distant recurrence risk in years 5–15 after diagnosis for patients who had no distant recurrence during the first five years of endocrine therapy alone and did not receive extended endocrine therapy.

• Official report explanation and example

According to the manufacturer’s patient information, an EPclin score below 3.33 is classified as low risk, while a score of 3.33 or above is classified as high risk. This is a prognosis, not a guarantee that the disease will or will not recur.

Low risk does not in itself mean that chemotherapy or longer endocrine therapy is definitely unnecessary. The result helps weigh possible benefits and adverse effects alongside other clinical data.

A doctor assesses whether the test is suitable and interprets the results. Do not change treatment yourself based on a single number or an example report.

• Eurobio Scientific: explanation of results for patients

The test uses tumour tissue collected during biopsy or surgery. The clinician source specifies formalin-fixed, paraffin-embedded (FFPE) tissue collected before systemic treatment.

The pathology laboratory assesses whether the available tissue is suitable. An existing sample is usually used; the patient should not send tissue or collect blood herself, as ordering and sample preparation must be coordinated with the doctor and laboratory.

The test is performed in a qualified molecular pathology laboratory. The specific testing location and sample shipment are agreed before ordering.

• Sample and testing process for patients
• Information for pathology laboratories

First, the doctor discusses whether the test could help with a specific treatment decision. Preparation of the existing tumour tissue, the required clinical data and shipment are then arranged.

The doctor discusses the laboratory report alongside the diagnosis, pathology findings, treatment options and the patient’s priorities. PharmaDNA can provide information about arranging the test; specific local conditions are confirmed individually.

Confirm the price, expected turnaround time and payment conditions before ordering. Conditions provided by the manufacturer for other countries may differ.

• Official EndoPredict testing process

The 2019 analysis by Filipits and colleagues assessed 1,702 women with ER+ / HER2− breast cancer from the ABCSG-6/8 cohorts who received five years of endocrine therapy. EPclin remained prognostically significant for early and late distant recurrence.

The 2019 pooled analysis by Sestak and colleagues compared cohorts of 2,630 women treated with endocrine therapy alone and 1,116 treated with chemotherapy plus endocrine therapy. The authors emphasise that this was an indirect, non-randomised comparison; the groups differed in clinical characteristics. Modelled benefit must therefore not be presented as a promise of an individual treatment outcome.

Eurobio Scientific provides additional data on use before and after menopause, different nodal statuses and real-world clinical practice. When selecting treatment, this evidence is assessed alongside current guidelines and the patient’s specific situation.

• Filipits et al., 2019 — early and late recurrence
• Sestak et al., 2019 — chemotherapy benefit analysis
• Eurobio Scientific: clinical evidence
• Manufacturer’s test comparison and bibliography

The official report presents the molecular score, EPclin group and risk estimates used in treatment planning separately. If pathological tumour size and nodal status are not yet known, the manufacturer describes an initial summary based on the molecular score; this is not the same as a complete EPclin assessment.

The manufacturer’s example is intended to explain the structure of the report. Its figures are not an individual patient’s result.

• Official report explanation and documents
• Patient information
• Distant recurrence data
• Chemotherapy benefit data