Genomic Health, Inc. has announced that, as of April 1, 2015, the Oncotype DX® test will be available to eligible breast cancer patients through the National Health Service (NHS) in England as the only multi-gene breast cancer test recommended by the National Institute for Health and Care Excellence (NICE) for use as an option to assist in chemotherapy treatment decision-making.
The access program enables NHS hospitals to provide genomic testing to some of their patients by implementing the NICE final guidance, which recommends Oncotype DX as the only breast cancer test for use as an option to assist treatment decision-making in patients with early-stage, hormone receptor-positive, HER2 negative, invasive breast cancer.
In setting up the program, NHS England recognized the conclusion of NICE that use of Oncotype DX in patients "at intermediate risk of distant recurrence, when the decision to prescribe chemotherapy remains unclear, would represent a cost-effective use of NHS resources."
"The improved access to a test that allows for a better understanding of individual tumor biology is an important step forward to personalized care for UK breast cancer patients," said Nigel Bundred, M.D., professor in surgical oncology, University Hospital of South Manchester NHS Foundation Trust. "Having this knowledge can give us greater confidence in recommending a treatment plan best suited for an individual patient which decreases the complications of treatment without compromising survival. The Oncotype DX breast cancer test should be routinely used for all eligible patients throughout the country."
Criteria currently used for making treatment decisions in clinical practice in England may result in substantial overtreatment and unnecessary costs for the healthcare system. Research shows that fewer than 10 percent of patients with early-stage breast cancer actually benefit from chemotherapy, while almost one-third of treatment recommendations for early-stage breast cancer patients in the UK change after the use of the Oncotype DX test. The Oncotype DX breast cancer test is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer, which has led to its inclusion in all major international guidelines (ASCO®, NCCN®, St. Gallen and ESMO).
"The NHS decision brings us an important step closer to achieving our goal of improving the quality of treatment decisions for cancer patients worldwide," said Brad Cole, chief operating officer and chief financial officer, Genomic Health. "In the past few years, more than 3,500 women in the UK have used the Oncotype DX test, and we believe the latest agreement will facilitate quick adoption throughout England."