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 DG34 will be withdrawn and replaced with new guidance which will include recommendations on tumour profiling tests for LN-positive early breast cancer and the existing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.

Diagnostics consultation: 1

Diagnostics consultation document

The National Institute for Health and Care Excellence (NICE) is producing guidance on Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node-positive early breast cancer in the NHS in England. The diagnostics advisory committee has considered the evidence and the views of clinical and patient experts. 

 

You can now comment on the diagnostics consultation document.

 

It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from registered stakeholders, healthcare professionals and the public.

 

How to comment

You should read both the consultation document and the accompanying evidence (see the committee papers) before making any comments.

 

Please note, the development of this guidance is following expedited timelines. The resolution stage of the process has been combined with the consultation on the draft recommendations. Therefore, please do include any factual inaccuracies in your comments on the draft guidance.

We have a new way of making comments on this consultation. You must make your comments directly onto the online version of the consultation document. When you go into the document you will find instructions on how to use the new commenting software.  You can also review and edit your comments before you submit them.

You can download a PDF version of the consultation document, but you can only make comments on the online version.

 

 

Closing date for comments: 22 November 2023

 

About the consultation

The advisory committee is interested in receiving comments on the following:

Has all of the relevant evidence been taken into account?

Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

Are the recommendations sound, and a suitable basis for guidance to the NHS?

Are there any factual inaccuracies in the draft guidance?

 

Equality issues

NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the recommendations may need changing to meet these aims. In particular, please tell us if the recommendations:

 

could have a different effect on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology

could have any adverse effect on people with a particular disability or disabilities.

 

Please provide any relevant information or data you have about such effects and how they could be avoided or reduced.

 

Note that this document is not NICE's final guidance on Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node-positive early breast cancer. The recommendations in section 1 may change after consultation.

 

After consultation, the committee will meet again to consider the evidence, this document and comments from the consultation. After considering the comments, the committee will prepare its final recommendations, which will be the basis for NICE’s guidance on the use of the technology in the NHS in England.

 

Find out more

 

For further details, see the diagnostics assessment programme manual

 

If you have any problems, contact diagnostics@nice.org.uk