Genomic Health Announces Presentation of First Prospective Outcomes Study of Oncotype DX® Breast Cancer Test

SAN ANTONIO, Dec. 10, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced early results from Europe's largest contemporary adjuvant breast cancer trial, which used the Oncotype DX^® breast cancer test to identify higher-risk patients who would benefit from the treatment. The early results of the study, conducted by the Women's Healthcare Study Group (WSG), represent the first prospective outcomes data on prognosis supporting the use of Oncotype DX to guide whether to add chemotherapy to standard hormonal therapy in estrogen receptor positive breast cancer.

"Our study results show that a low Recurrence Score identifies patients who can be safely spared chemotherapy without compromising outcomes.  These results confirm prospectively conducted earlier trials," said professor Ulrike Nitz, lead investigator of the study, head of breast cancer unit at the Bethesda Hospital, Moenchengladbach, Germany.   

The WSG trial was designed to evaluate the efficacy of an anthracyline-free adjuvant chemotherapy regimen and utilized the Oncotype DX breast cancer test to identify higher-risk patients who would be more likely to benefit from chemotherapy treatment. In the study of 3,198 patients, mostly qualified as candidates for chemotherapy by traditional parameters, patients with Recurrence Score^® results of 12 or higher were randomized to one of two different chemotherapy regimens, and patients with Recurrence Score results of 11 or less were offered hormonal therapy alone. After nearly three years of follow-up, patients with Recurrence Score results of 11 or less had very high survival rates without evidence of recurrence (98.3 percent), despite having node-positive disease or high-risk node-negative disease by traditional parameters. Researchers will continue to follow patients and report results on drug treatment and longer-term outcomes.

"Over the last decade, we have consistently demonstrated that genomic information from Oncotype DX can transform cancer treatment," said Phil Febbo, M.D., chief medical officer, Genomic Health.  "While the prospective data continue to mature, these early encouraging results highlight our test's proven ability to stratify patient risk to continue to personalize treatment for cancer patients and transform cancer treatment worldwide."

The WSG study results will be presented at the 2014 San Antonio Breast Cancer Symposium (SABCS) on Friday, December 12 from 7:30 - 9 a.m. Central Time at the Henry B. Gonzalez Convention Center. Additionally, the following studies will be presented:

• Abstract S1-06: "Stromal tumor-infiltrating lymphocytes(S-TILs): In the alliance N9831 trial S-TILs are associated with chemotherapy benefit but not associated with trastuzumab benefit." Perez EA, Ballman KV, Anderson SK, Thompson EA, Badve SS, Bailey H, Baehner FL.
• Abstract P3-06-35: "Association of estrogen receptor (ER) levels and prediction of antiproliferative effect of hormone therapy (HT) in lower ER-expressing tumors."
  Dixon JM, Turnbull A, Renshaw L, Rothney MP, Loman CA, Arthur L, Thomas JS, Young O, Murray J, Williams L, Sing AP, Cameron D.
• Abstract P4-02-08: "Global quantitative measures using next-generation sequencing for breast cancer presence outperform individual tumor markets in plasma." Beasley EM, Abramson RD, Alexander GE, Chan D, Bradley K, Collin F, Crager M, Dei Rossi A, Dorado J, Friedman A, Gibb WJ, Jeong J, Jones C, Ku CJ, Ma Y, Morlan J, Qu K, Rao A, Scott A, Tezcan H. 
• Abstract P6-08-06: "The Multidisciplinary Application of Genomics in Clinical Practice (MAGIC) survey: Identification of early-stage hormone receptor-positive (HR +), HER2-breast cancer (BC) patients for whom multigene assays may be valuable." Aapro M, Bargallo Rocha JE, De Laurentiis M, Elizalde R, Landherr L, Linderholm B, Mamounas T, Markopoulos C, Martin M, Neven P, Petrovsky A, Rea D, Rouzier R, Smit V, Svedman C, Thomssen C.

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 70 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 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 attributes and benefits of the company's tests to physicians and patients; the attributes and focus of the company's product pipeline; the company's belief that it is applying its infrastructure and expertise to lead the translation of genomic data into clinically actionable results; the ability of any potential tests the company may develop to optimize cancer treatment; and the applicability of early clinical study results to long term study results and actual outcomes. 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 September 30, 2014. 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.

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SOURCE Genomic Health, Inc.

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