Evidence-based recommendations on tumour profiling tests to guide adjuvant chemotherapy decisions for people with early breast cancer. The tests are EndoPredict (EPclin score), Oncotype DX Breast Recurrence Score, Prosigna, MammaPrint and IHC4+C.
Is this guidance up to date?
Update in progress
NICE's diagnostics guidance on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer (DG34) makes recommendations on tumour profiling tests for oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer.
This guidance will assess use of the tests for ER-positive, HER2-negative cancer that has spread to the lymph nodes (LN-positive early breast cancer). DG34 will be withdrawn and replaced with new guidance which will include recommendations on tumour profiling tests for LN-positive early breast cancer and the existing recommendations on tumour profiling tests for LN-negative early breast cancer. For further details on this update, see the guidance in development page.
There is an access proposal for EndoPredict. Contact NHS_EndoPredict@myriad.com or 020 3897 6620 or 6621 for details.
There is an access proposal for Oncotype DX. Contact SOgram@genomichealth.com or 020 3031 8087 for details.
There is an access proposal for Prosigna. Contact email@example.com or 01494 590430 for details.
Guidance development process
This guidance replaces NICE diagnostics guidance on gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat (DG10). It also replaces NICE medtech innovation briefings on Prosigna gene expression profiling assay for assessing long‑term risk of breast cancer recurrence (MIB27) and EndoPredict gene expression profiling assay for assessing risk of breast cancer recurrence (MIB44).
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.