Following NICE's Exclusive Recommendation, NHS England Agrees to Access Program for Oncotype DX® Breast Cancer Test

Agreement Marks Important Milestone in Delivering Personalized Medicine to More Breast Cancer Patients Worldwide

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Feb 05, 2015, 07:00 ET

REDWOOD CITY, Calif., Feb. 5, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) announced today 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 chemotherapy¹, 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.² 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."

About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company's flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With half a million patients tested in more than 70 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or www.mybreastcancertreatment.org.

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive 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 European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the company's test should be used for all eligible patients in the country; the belief that the agreement with NHS will facilitate quick adoption in England; the benefits and attributes of the company's tests to physicians and patients; the attributes and focus of the company's product pipeline; the company's belief that it is applying its infrastructure and expertise to lead the translation of genomic data into clinically-actionable results; and the applicability of clinical study results to actual outcomes. 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: adequate funding for the company's test by NHS England; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our 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 quarterly report on Form 10-Q for the quarter ended September 30, 2014. 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, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

NCCN® and NCCN Guidelines are registered trademarks of the National Comprehensive Cancer Network. ASCO® is a registered trademark of the American Society of Clinical Oncology. NCCN and ASCO do not endorse any therapy or product.