Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason the tumour profiling test Oncotype DX has not been included in NHS England’s National Genomic Test Directory.

The National Institute for Health and Care Excellence (NICE) published diagnostics guidance in 2013 on the use of gene expression profiling and expanded immunohistochemistry tests for guiding adjuvant chemotherapy decisions in early breast cancer management, including Oncotype DX. NICE’s guidance recommends Oncotype DX subject to specific clinical criteria to help make decisions about chemotherapy after surgery in some people with oestrogen receptor positive (ER+), lymph node negative (LN−) and human epidermal growth factor receptor 2 negative (HER2−) early breast cancer.

NHS England will be reflecting the 2013 NICE guidelines related to Oncotype DX in the National Genomic Test Directory for cancer. However it is important to note that the NICE guidance relating to this intervention is under review and once a decision has been made by NICE, this information will be considered as part of the regular review and update of the Test Directory.