EndoPredict is a multi‑gene assay that predicts the likelihood of women with oestrogen receptor (ER)‑positive and human epidermal growth factor receptor 2 (HER2)‑negative breast cancer developing metastases within 10 years of the initial diagnosis. The test combines measurements of gene expression (the EndoPredict [EP] score) with nodal status and tumour size to generate a comprehensive risk score (the EPclin score) which is used to identify tumour types that will not benefit from chemotherapy. The published clinical evidence summarised in this briefing comes from 3 analytical validation and 5 clinical validation studies in which the test was generally shown to be reproducible and to have prognostic power. In 1 impact evaluation study, EndoPredict results were reported to change treatment decisions. A cost‑effectiveness analysis found that using EndoPredict in combination with non‑UK clinical guidelines was less costly and more effective than clinical guideline risk stratification alone. One EndoPredict test costs £1000 if performed in a local laboratory or £1500 if it is sent to the distributor's laboratory.
Published November 2015
NICE page: https://www.nice.org.uk/advice/MIB44