Regulatory Focus™ > News Articles > NICE Green Lights IVD for Breast Cancer Diagnosis

NICE Green Lights IVD for Breast Cancer Diagnosis

Posted 21 February 2013 | By Louise Zornoza 

The UK's cost containment agency, the National Institute of Health and Clinical Excellence (NICE), has agreed to recommend the use of an innovative new diagnostic test designed to guide the use of chemotherapy in patients with early breast cancer.

Specifically, the recommendation covers the use of Oncotype DX in patients in the early stages of oestrogen receptor positive (ER+), lymph node negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. These are forms of breast cancer for which gene expressions tests are thought to be able better determine whether adjuvant chemotherapy will provide benefit in an individual following initial treatment.

NICE issued the draft guidance on 18 February 2013 only after the manufacturer of Oncotype DX agreed to lower the price for the diagnostic test, which measures the presence of markers within the tumor that may indicate how the tumor is likely to progress. The draft guidance recommends the use of the test for women at intermediate risk of metastasis, where the decision to prescribe chemotherapy remains unclear.

The recommendation allows the product to be used and reimbursed by the National health Service (NHS).

NICE also turned down three tests from different entities for similar use. The body said that it is unable to support the routine use of Agendia's MammaPrint, Clarient's Mammostrat or the IHC4 test, which was developed within the NHS itself, because the evidence that these tests can predict the level of response in chemotherapy is "uncertain". It did, however, recommend that further research be carried out on whether these tests are effective to inform the treatment of breast cancer patients.

Breast cancer is the most commonly diagnosed cancer in women in England and Wales. In 2010 there were over 42,000 new cases diagnosed. It is also the second largest cause of cancer death in women after lung cancer. In 2010, breast cancer resulted in 10,328 deaths for women in England and Wales.


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