NICE has developed a medtech innovation briefing (MIB) on the EndoPredict gene expression profiling assay for assessing risk of breast cancer recurrence.
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.
Medtech innovation briefings provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement.
MIBs are commissioned by NHS England and produced in support of the NHS 5 Year Forward View, specifically as one of a number of steps which will accelerate innovation in new treatments and diagnostics.