EndoPredict® Breast Cancer Prognostic Test
Use
EndoPredict® is intended for in vitro analysis of formalin-fixed paraffin-embedded (FFPE) resection and biopsy specimens from primary female invasive breast cancer that is estrogen receptor positive and HER2 negative. It is used to determine the 10-year risk of distant recurrence, the likelihood of distant recurrence 5–15 years after diagnosis, and the estimated absolute benefit of chemotherapy at 10 years. For resected tissue, a 12-Gene Molecular Score is combined with tumor size and lymph node status to generate an EPclin Risk Score with associated recurrence risks.
Special Instructions
Complete the EndoPredict® Test Request Form (TRF) to avoid delays. Send the TRF to the pathology lab to initiate tissue processing; then email forms/documents to [email protected] or fax to 801-583-8248. You may request Myriad to retrieve the specimen by completing the specimen retrieval section. Attach a demographics sheet, pathology report, and insurance card copy when applicable.
Limitations
Performance has not been established for non-invasive samples, tumors that are not ER+/HER2-, non-breast tissue, male breast cancer tumors, or patients who received systemic treatment prior to biopsy or resection (e.g., neoadjuvant chemotherapy or radiation), which may affect performance and result accuracy. Samples frozen prior to fixation are not appropriate. The reported recurrence risk and chemotherapy benefit estimates are based on cohorts of women meeting specified clinical characteristics; risks may differ for individuals who do not meet these characteristics, and results are considered invalid if a distant recurrence has already occurred.
FDA ApprovedNew York Approved
Methodology
PCR-based (RT-qPCR)
Biomarkers
12-Gene Molecular Score
SignatureEPclin Risk Score
Signature
Result Turnaround Time
10-14 days
Related Documents
Not provided.
Specimen
Tissue
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Blocks should include a portion of lesion with ≥30% invasive tumor on the diagnostic H&E slide (biopsy specimens: >50% invasive tumor recommended). If blocks are unavailable, an H&E slide followed by consecutive unstained slides may be acceptable. Specimen must be formalin-fixed paraffin embedded.
Patient Preparation
Tissue previously treated with systemic therapy prior to biopsy/resection (e.g., chemotherapy, radiation therapy, or endocrine therapy) is inappropriate / not suitable for testing.
Causes for Rejection
Samples frozen prior to fixation are not appropriate for analysis. Samples in non-validated tissues (non-breast tissue) will not be accepted for testing. Samples with less than the 30% minimum invasive tumor may lead to test cancellation.
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