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Updated St. Gallen International Breast Cancer Guidelines, for the Second Time, Recognize Oncotype DX® as the Only Validated Multi-Gene Test Able to Predict Chemotherapy Benefit

August 22, 2013

The 13th St. Gallen International Expert Consensus Panel Report Emphasizes Oncotype DX’s Unsurpassed Clinical Validation Supporting Greater Use and Reimbursement of the Test Worldwide

GENEVA and REDWOOD CITY, Calif., Aug. 22, 2013 /PRNewswire/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced that the 13(th) St. Gallen International Breast Cancer Conference Expert Panel, for the second time, recognized the Oncotype DX(®) breast cancer test for its ability to provide not only prognostic information, but also predictive information regarding the benefit from chemotherapy for patients with early-stage endocrine sensitive invasive breast cancer. Oncotype DX was the only multi-gene test accepted with a strong majority of panelists supporting it as both a prognostic and predictive tool, which led to “a recommendation that selection of patients who might forego chemotherapy could be based on the 21-gene Recurrence Score.” The new guidelines have been recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

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“We are pleased that this expert panel recognizes the unsurpassed clinical evidence of Oncotype DX as the only test validated to answer the important question of which estrogen receptor-positive breast cancer patients need chemotherapy in addition to hormonal therapy,” said Steven Shak, M.D., chief medical officer and executive vice president of research and development, Genomic Health. “Physicians in more than 70 countries have used Oncotype DX for treatment planning in more than 375,000 patients to date, enabling patients to make more informed decisions and healthcare systems to avoid overtreatment.”

The updated guidelines, which are reviewed bi-annually, reflect increasing support for the use of multi-gene tests to provide physicians and patients with information that goes beyond traditional clinic-pathologic measures to enable better informed treatment decisions. The guidelines also reference that the use of the Oncotype DX breast cancer test is either cost-effective or provides cost savings in all markets analyzed.

“The growing acceptance of utilizing genomics as an integral treatment decision tool is an important milestone to improve the treatment of breast cancer overall,” said Martine Piccart, M.D., chief of the Medicine Department at the Jules Bordet Institute in Brussels, Belgium, member of the St. Gallen International Breast Cancer Expert Panel, and president of the European Society of Molecular Oncology (ESMO). “The panel acknowledges the added value that genomic assays can provide and encourages broader availability for these assays so that more patients can benefit from them. As we mark the tenth anniversary of the first full sequencing of the human genome, we will continue our efforts to enhance breast cancer care around the world.”

The Oncotype DX breast cancer test has been evaluated in 15 clinical studies involving more than 6,000 patients, and is the only genomic assay to meet level 1B evidence (Simon RM, Paik S, and Hayes DF. JNCI 2009) for clinical use in early-stage, hormone receptor-positive, invasive, breast cancer patients both as a prognosticator and predictor of likelihood of benefit from chemotherapy. Separately, with more than 18 decision impact studies conducted in 10 countries, the test has consistently been demonstrated to change treatment recommendations in about 30 percent of early-stage invasive breast cancer patients, reinforcing its clinical validation, accuracy and precision. Additionally, more than 20 health economic analyses conducted in Europe, Asia, Israel, and North America demonstrate that the Oncotype DX test is cost effective and, in some countries, delivers significant healthcare savings, reinforcing the test’s economic value across multiple health care systems.

About Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. The company’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. Genomic Health has a robust pipeline focused on developing tests to further optimize the treatment of breast, colon and prostate cancers, as well as the treatment of renal cancer. 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 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 is cost effective and can reduce the cost of treatment in various health systems around the world; the company’s belief that it has the opportunity to advance the quality of cancer treatment decisions and that the inclusion of Oncotype DX in the St. Gallen guidelines will enable greater international utilization of Oncotype DX; the applicability of study results to actual outcomes; the ability of the company’s tests to impact clinical practice; and the focus and attributes of the company’s product pipeline. 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: risks related to the success of the company’s colon and prostate cancer tests; 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; the company’s ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts; ; the company’s ability to successfully commercialize its tests outside of the United States; 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.


Source: PR Newswire