Updated NICE quality standard recommends Oncotype DX® in early-stage breast cancer


Media: Hazel Davis
hazeldavis@gmail.com
07832234312


• Multi-gene test developed by Genomic Health predicts likelihood of chemotherapy benefit and risk of disease recurrence

• Latest quality standard reveals areas for improvement in breast cancer treatment


[London, 20 June, 2016] Genomic Health UK announced that the National Institute for Health and Care Excellence (NICE) has published its latest quality standard, recommending the use of the Oncotype DX test in eligible patients with early-stage breast cancer.

The new standard states that people with oestrogen receptor-positive (ER-positive), human epidermal growth factor receptor 2-negative (HER2-negative) and lymph node-negative early breast cancer who are at intermediate risk of distant recurrence should be offered gene expression profiling with Oncotype DX.

The test provides information about the genetic makeup of a tumour and predicts whether a patient is likely to benefit from chemotherapy. This can help avoid unnecessary chemotherapy and the associated harmful side-effects and costs.

“Oncotype DX is an important diagnostic tool that can help spare women from the side-effects of chemotherapy,” said Dr Jeremy Braybrooke, Consultant Medical Oncologist, University Hospitals Bristol NHS Foundation Trust. “It enables us to look at the fundamental drivers of a particular tumour and make more informed decisions about who will benefit most from treatment with chemotherapy.”

Breast cancer is the most common cancer in the UK, with more than 50,000 new cases diagnosed and nearly 12,000 deaths recorded in 2013.

The NICE quality standard has been updated to reflect changes in the national priorities for improvements in breast cancer care since the original standard’s publication in 2011. Genomic expression profiling is one of six statements that require attention of commissioners, health care professionals and service providers to help drive more widespread and consistent adoption in order to improve the quality of care.

“The data shows that patients feel more confident in their decision when using this test and it assists them at a time when they are potentially vulnerable,” said Dr Victoria Harmer, Lead Breast Nurse Specialist, Imperial College Healthcare NHS Trust. “We welcome the updated NICE quality standard which aims to improve the quality of care for breast cancer patients through more personalised treatment decisions.”

Oncotype DX is the only multi-gene test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Following assessment and recommendation by NICE in 2013, the test is now widely available to patients across the UK and has been used to personalise treatment decisions in 600,000 patients worldwide.

About Genomic Health
Genomic Health, Inc. is a world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The company is based in Redwood City, California with UK headquarters in London. For more information, please visit www.GenomicHealth.co.uk. To learn more about Oncotype DX, visit: www.OncotypeDX.com

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the ability of any potential tests Genomic Health, Inc. may develop to optimize cancer treatment and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's yearly report on Form 10-K for the quarter ended March 31, 2016. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.