NICE has developed a medtech innovation briefing (MIB) on the Prosigna gene expression profiling assay for assessing long-term risk of breast cancer recurrence.
Prosigna is a prognostic gene signature assay that measures gene expression to calculate the risk of women with early-stage breast cancer developing distant recurrence 10 years from diagnosis. The assay measures the expression profiles of all 50 of the genes included in the PAM50 gene signature, and can be performed on RNA isolated from formalin-fixed, paraffin-embedded breast tumour tissue.
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 professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
Medtech innovation briefings are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.
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.