Genomic Health Inc.

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NICE Recommends Genomic Health's Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients

REDWOOD CITY, Calif., Sept. 25, 2013 /PRNewswire/ -- Genomic Health, Inc. today announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer.  Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO® and St. Gallen, NICE's recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.

(Logo: http://photos.prnewswire.com/prnh/20130425/SF01493LOGO)

"It is encouraging to see growing recognition of the value of genomic testing.   Its provision has enhanced the care of breast cancer patients around the world and it will now be available as an option in the UK," said David Miles, M.D., medical oncologist at Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom. "NICE's recommendation for the use of Oncotype DX in the UK is an important step forward, enabling physicians and patients to make better-informed treatment decisions based on the biology of an individual patient's breast cancer." 

To date, more than 1,500 women in the UK have utilized the Oncotype DX test to help guide their treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, with almost 50,000 people diagnosed each year in the UK.  Most of these patients are diagnosed with early-stage, invasive breast cancer and a significant number of them could benefit from this test under the NICE recommendation.

"The decision of whether or not to undergo chemotherapy is an extremely important and difficult one for patients, not only due to the many side effects associated with treatment, but also due to the hardship for the patient and her family and the loss of income due to days off work.  Allowing patients and their physicians to make more personalized treatment decisions can help improve outcomes for the rising number of early-stage breast cancer patients in Europe," said Kathi Apostolidis, vice president, European Cancer Patient Coalition, Brussels, Belgium, and a two-time breast cancer survivor, commenting on the NICE announcement.  "We hope NICE's decision will also inspire other European countries to provide broader access to novel diagnostics such as Oncotype DX, which allows informed decision making for sparing the burden of chemotherapy from those who do not need it." 

With data showing that only four out of 100 early-stage invasive breast cancer patients benefit from chemotherapy, the Oncotype DX test helps improve patient outcomes by personalizing treatment decisions through assessment of the risk of cancer recurrence and chemotherapy benefit.

"Given NICE's rigorous review process and its influence throughout the region, we believe this decision brings us an important step closer to achieving our mission to improve the quality of treatment decisions for cancer patients across Europe and around the world," said Steven Shak, M.D., executive vice president of research and development, Genomic Health.  "Our extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide.  Based on NICE's recommendation, we will work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX test for UK patients."

The robust body of evidence supporting Oncotype DX includes 15 clinical studies in more than 6,000 patients; 18 decision impact studies from 10 countries, which consistently demonstrate an approximate 30 percent change in treatment recommendations; and more than 20 studies from nine countries, showing that the use of the test is cost-effective in all health systems analyzed.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is is the world's leading provider of genomic-based diagnostic tests that address the overtreatment 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 throughout the cancer patient's journey, from screening and surveillance, to diagnosis, to treatment selection and monitoring.  Genomic Health's lead 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 and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of June 30, 2013, more than 19,000 physicians in over 70 countries had ordered more than 375,000 Oncotype DX tests.  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. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

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 Oncotype DX Breast Cancer test is unique in its ability to predict chemotherapy benefit in early stage breast cancer; the company's belief that the Oncotype DX Recurrence Score®  cannot be predicted by other factors such as age or individual biomarkers; the company's belief that the Oncotype DX Breast Cancer test  is cost effective and can reduce the cost of treatment in the United Kingdom and in various other health systems around the world; that the recommendation by NICE will lead to increased use of the  Oncotype DX  Breast Cancer test in the United Kingdom; the applicability of study results to actual outcomes; and the ability of the company's tests to impact clinical practice. 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 company's ability to increase usage of its tests; the company's ability to successfully commercialize its tests outside of the United States; the company's ability to compete against third parties; 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 and uncertainties associated with regulation of the company's tests by the FDA and other regulatory organizations;the company's ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts;  the results of clinical studies; the applicability of clinical study results to actual outcomes; 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 June 30, 2013. 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.

SOURCE Genomic Health, Inc.

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