Recommendation ID
DG10/3
Question
IHC4: research into the analytical validity (reliability and reproducibility) of the complete IHC4 test is recommended (an algorithm combining 4 markers and classical clinical and pathological variables), particularly within the NHS and when performed in local laboratories. Studies to confirm the prognostic ability and to determine the impact of IHC4 on clinical decision-making in England and, ideally, to predict the benefit of chemotherapy are recommended.
Any explanatory notes
(if applicable)
Research is recommended in the context of people with oestrogen receptor positive (ER+), lymph node negative (LN−) or human epidermal growth factor receptor 2 negative (HER2−) early breast cancer.
MammaPrint, IHC4 and Mammostrat are only recommended for use in research in people with ER+, LN− and HER2− early breast cancer, to collect evidence about potentially important clinical outcomes and to determine the ability of the tests to predict the benefit of chemotherapy (see section 7). The tests are not recommended for general use in these people because of uncertainty about their overall clinical benefit and consequently their cost effectiveness.

Source guidance details

Comes from guidance
Gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management: MammaPrint, Oncotype DX, IHC4 and Mammostrat
Number
DG10
Date issued
September 2013

Other details

Is this a recommendation for the use of a technology only in the context of research? No  
Is it a recommendation that suggests collection of data or the establishment of a register?   No  
Last Reviewed 08/10/2013