Regulatory Focus™ > News Articles > Genomic’s Breast Cancer IVD Gets Green Light from UK’s NICE

Genomic’s Breast Cancer IVD Gets Green Light from UK’s NICE

Posted 26 September 2013 | By Louise Zornoza

The UK cost containment agency, the National Institute for Health and Care Excellence (NICE), recommended on 25 September 2013 that the Oncotype DX test (Genomic Health) should be reimbursed by the National Health Service (NHS) as an option to help clinicians decide whether to prescribe chemotherapy to patients with early breast cancer.

The test measures the presence of biological characteristics within a tumor that may indicate how it is likely to grow and whether it is more or less likely to spread. Used together with other information such as tumor size and grade, the test facilitates the targeting of chemotherapy more effectively by identifying those patients who would be most suitable for treatment with chemotherapy.

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. For some patients with a 'good' prognosis, their cancer can return despite surgery and adjuvant (additional) therapy. 

Tags: UK

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