Guidance
Evidence-based recommendations on tumour profiling tests (EndoPredict, ICH4+C, MammaPrint, Oncotype DX and Prosigna) to guide adjuvant chemotherapy decisions in early breast cancer.
Commercial arrangements
There are access proposals for EndoPredict, Oncotype DX and Prosigna. Contact the following for details:
- EndoPredict: info@myriadgenetics.de or +49 89 414 142400
- Oncotype DX: europeansupport@exactsciences.com or 020 3031 8087
- Prosigna: info@prosigna.com
Guidance development process
How we develop NICE diagnostics guidance
This guidance replaces NICE diagnostics guidance 34 (DG34) on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. The DG34 recommendations for lymph node-negative (including micrometastatic disease) early breast cancer have been incorporated into this guidance.
Your responsibility
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.