|By PR Newswire||
|April 22, 2014 08:01 AM EDT||
REDWOOD CITY, Calif., April 22, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced two important international milestones including additional reimbursement in Canada and the inclusion of the Oncotype DX® breast cancer test in major German clinical guidelines. In Canada, the BC Cancer Agency in British Columbia agreed to fund the Oncotype DX breast cancer test for eligible patients, expanding reimbursement to more than 80 percent of the country's population. In Germany, updated guidelines from the AGO (Gynecologic Oncology Working Group) now recommend the Oncotype DX breast cancer test as the only gene expression test to predict chemotherapy benefit in early-stage hormone receptor-positive invasive breast cancer.
"The opportunity to reach breast cancer patients worldwide is a key area of focus and investment for 2014 that will drive future growth," said Brad Cole, chief operating officer, Genomic Health. "These two accomplishments, combined with the National Institute for Health and Care Excellence's (NICE's) recent recommendation of Oncotype DX, represent significant progress internationally."
With the BC Cancer Agency decision, British Columbia becomes the fifth province to reimburse the test, following Ontario, Quebec, Saskatchewan and Newfoundland.
"Understanding a patient's individual tumor biology gives us greater confidence in recommending a treatment plan better suited for that patient, and in early-stage invasive breast cancer, Oncotype DX enables just that," said Stephen Chia, M.D., oncologist and clinical investigator with the BC Cancer Agency. Dr. Chia conducted a study of the Oncotype DX test in British Columbia, which showed that the test's results changed chemotherapy treatment decisions for 30 percent of patients.
"This is a significant step forward for patients affected by breast cancer in British Columbia," said MJ DeCoteau, executive director of Rethink Breast Cancer, a national patient organization in Canada. "Being able to make individualized treatment decisions can have a huge impact on patients' lives. We are pleased that Oncotype DX is now going to be available to all eligible patients in British Columbia. Our hope is that all provinces will harness the medical advances in genomics, enabling physicians to personalize their patients' cancer treatment."
Separately, the latest version of the AGO guidelines for breast cancer patient care in Germany added the Oncotype DX test as a predictor of chemotherapy benefit in early-stage invasive breast cancer patients. AGO's decision is consistent with leading international guidelines from NICE in the United Kingdom, the European Society of Medical Oncology (ESMO®) in Europe, St. Gallen, and the American Society of Clinical Oncology® (ASCO®) and the National Comprehensive Cancer Network® (NCCN®) in the United States, which all underscore the unparalleled clinical evidence for Oncotype DX as the only genomic test validated to provide prediction information to guide chemotherapy decisions.
To date, Genomic Health has provided test results to patients in more than 70 countries and has secured reimbursement of the Oncotype DX test for approximately 115 million patients outside of the United States, demonstrating global leadership in delivering reliable genomic answers to breast, colon and prostate cancer patients worldwide, while enabling healthcare systems to avoid overtreatment.
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 screening and surveillance, through diagnosis, 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 December 31, 2013, more than 19,000 physicians in over 70 countries had ordered approximately 420,000 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 OncotypeDX 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 demand for our Oncotype DX Breast Cancer test in Europe; the advantages of the Oncotype DX Breast Cancer test over other tests in guiding the use of chemotherapy in early stage breast cancer treatment; the applicability of study results to actual outcomes; the ability of the company's tests to impact clinical practice; the ability of the company to develop and commercialize additional tests in the future; the attributes of the company's product pipeline; and the scope, success or results of clinical trials and the timing of such activities. 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 applicability of study results to clinical practice; the timing and results of future studies or clinical trials; the focus and attributes of the company's product pipeline; the ability of the company to develop additional tests in the future; and the ability of the company's currently offered tests, including its breast cancer test, and any potential tests the company may develop to optimize cancer treatment; the company's ability to increase usage of its tests; 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 compete against third parties; 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 Annual Report on Form 10-K for the period ended December 31, 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. Clinical guidelines do not endorse any product or therapy.
SOURCE Genomic Health, Inc.
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