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Updated St. Gallen International Breast Cancer Guidelines reconfirm Oncotype DX® as the only multi-gene test validated to predict chemotherapy benefit

GENEVA, May 11, 2015 /PRNewswire/ -- Genomic Health today announced that the 14th St. Gallen International Breast Cancer Conference Expert Panel, for the third time, recognised the Oncotype DX® breast cancer test for its ability to provide not only prognostic but also predictive information regarding the likelihood of chemotherapy benefit for patients with early-stage, endocrine sensitive, invasive breast cancer.

The Oncotype DX test was the only multi-gene test accepted with a strong majority of panelists supporting it as a predictive tool. 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.

"Many newly diagnosed breast cancer patients face the difficult decision of whether or not to undergo chemotherapy," said Dr Angelo Di Leo, member of the St. Gallen Expert Panel and Head of the Medical Oncology Unit at the Hospital of Prato, Istituto Toscano Tumori, Italy. "A tool like the Oncotype DX test can be helpful in identifying the group of patients with endocrine sensitive breast cancer who are likely to derive benefit from adjuvant chemotherapy."

Criteria currently used for making chemotherapy treatment decisions in clinical practice may result in substantial overtreatment and unnecessary costs for the healthcare system. Research shows that less than 10% of patients with early-stage breast cancer actually benefit from chemotherapy1,2 and about one-third of treatment recommendations for early-stage breast cancer patients change after the use of the Oncotype DX test.3

More than 20 studies conducted in both developed and emerging markets have shown that testing with the Oncotype DX test represents a cost-effective use of healthcare resources. Results presented recently from a real-life observational study conducted in Ireland4 showed that use of the Oncotype DX test in early-stage breast cancer led to a 58 percent net reduction in chemotherapy use, resulting in net cost savings of nearly €800,000. 

Healthcare systems across Europe are recognising the value of the test. Most recently, the National Health Service (NHS) in England agreed to an access program for the Oncotype DX breast cancer test. The test is also covered in Switzerland through the mandatory health insurance system and is reimbursed by the public insurance system in Ireland and in half of the regions of Spain. 

"We are pleased that this expert panel recognised once again the value of the Oncotype DX test. An extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer management by improving the quality of treatment decisions for patients while providing a positive impact on healthcare systems," said Calvin Chao, Senior Director of International Medical Affairs at Genomic Health.

The Oncotype DX breast cancer test is incorporated in all major international guidelines, including NICE, St. Gallen International Breast Cancer Expert Panel, ESMO, ASCO and NCCN. Since it became available in 2004, more than half a million tests have been requested by more than 19,000 physicians in over 70 countries.

About Genomic Health
Genomic Health, Inc. is a world-leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. 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 screening and surveillance, through diagnosis and treatment selection. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, http://www.genomichealth.com/. To learn more about the Oncotype DX test, visit: http://www.oncotypedx.com/

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the value, benefits and attributes of the company's tests to patients, physicians and payors. 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; 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 March 31, 2015. 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.

1 Paik S et al. J Clin Oncol 2006;24:3726-34.
2 Early Breast Cancer Trialists' Collaborative Group (EBCTCG), et al. Lancet. 2012:379;432-444.
3 Albanell, J. et al. ESMO 2012; poster 252PD.
4 Smyth L, Economic Impact of 21-gene Recurrence Score testing on Early Stage Breast Cancer in Ireland. St. Gallen 2015.

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