St. Gallen International Breast Cancer Guidelines for the Third Time Distinguish Oncotype DX® as the Only Multi-Gene Test Validated to Predict Chemotherapy Benefit

REDWOOD CITY, Calif., May 11, 2015 /PRNewswire/ -- Genomic Health (Nasdaq: GHDX) today announced that the 14th St. Gallen International Breast Cancer Conference Expert Panel, for the third time, recognized 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, estrogen receptor-positive, invasive breast cancer. Oncotype DX was the only multi-gene test accepted with a strong majority of panellists supporting it as a predictive tool to guide chemotherapy treatment decision making. The new guidelines were 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."

Standard clinical criteria commonly used for making chemotherapy treatment decisions prior to the availability of Oncotype DX often resulted in substantial overtreatment and unnecessary costs to the healthcare system. Research shows that less than 10 percent 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 It has been shown through more than 20 studies that testing with Oncotype DX saves costs across healthcare systems. Recently-presented results from Ireland⁴ showed that use of the Oncotype DX test in early-stage breast cancer reduced chemotherapy use by half, resulting in net cost savings of nearly €800,000, or approximately $900,000 U.S. dollars. 

The clinical validation studies of Oncotype DX in early-stage breast cancer have shown that the Recurrence Score is prognostic and predicts the benefit of adding chemotherapy at diagnosis with long-term follow-up of 10 years. Additionally, the Panel this year expressed substantial (43.8 percent) support for the prognostic value of Oncotype DX beyond five years, as it relates to considering whether to extend hormonal treatment for an additional five years in some patients.

"We are pleased that the St. Gallen expert panel recognized once again the unmatched value of Oncotype DX in guiding important chemotherapy treatment decisions as well as the test's benefit in better defining who is at greatest risk for late recurrences and may be considered for extended tamoxifen or aromatase inhibitor treatment," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Since our test became available in 2004, we have served more than half a million patients in over 80 countries, and our test continues to be recognized in international treatment guidelines, including NICE, St. Gallen ESMO®, and AGO in Germany."

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 80 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, YouTube 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 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.

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

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.

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