Genomic Health, Inc.
Mar 24, 2017
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Published Outcomes Results from SEER Registries Indicates That Many Node-positive Breast Cancer Patients Can Avoid Chemotherapy Based on Oncotype DX® Results

A Large Study Demonstrates Excellent Survival in Patients with Limited Nodal Involvement and Low Oncotype DX Breast Recurrence Score® Results

REDWOOD CITY, Calif., March 24, 2017 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the publication of results from the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Registry in the peer-reviewed journal Breast Cancer Research and Treatment, reconfirming the value of the Oncotype DX Breast Recurrence Score® in guiding chemotherapy treatment decisions in certain node-positive patients.

Consistent with previously published findings in Nature Partner Journals Breast Cancer, the new SEER Registries analysis demonstrates that breast cancer patients with limited node-positive disease who have low Breast Recurrence Score™ (RS) results have an excellent chance of breast cancer-specific survival (BCSS). These data, along with results from 14 additional Oncotype DX® studies in breast cancer patients, were also presented at the 15th St. Gallen International Breast Cancer Conference in Vienna.

"This population-based study is valuable proof that the RS 'works' not just in clinical studies but in the real world, and in patients with node-negative and node-positive breast cancers," said Harold J. Burstein, M.D., Ph.D., Dana-Farber Cancer Institute and Harvard Medical School. "It will help clinicians and patients feel yet-more-confident in using the Breast Recurrence Score to make decisions about chemotherapy treatment in early-stage breast cancer."

Representing the largest report of clinical outcomes in node-positive patients treated based on Oncotype DX, the study of 6,768 patients with lymph node-positive breast cancer showed that RS results were strongly predictive of BCSS (p < 0.001). Most importantly, five-year BCSS rate was excellent ( > 97 percent) for those with limited nodal involvement and a score of less than 18. These findings provide reassurance that these patients can be effectively treated with hormonal therapy alone without chemotherapy.

"We now have prospective outcomes data across multiple studies, including the SEER Registries, demonstrating that not all patients with positive nodes have aggressive disease and that patients with up to three positive nodes and Breast Recurrence Score results of less than 18 can be effectively treated with hormonal therapy alone and spared the toxicity of chemotherapy," said Steven Shak, M.D., chief scientific officer, Genomic Health. "These data support wider adoption of Oncotype DX in many node-positive patients to eliminate overtreatment and unnecessary toxicities in the low biologic-risk group."

Separately, in node-negative breast cancer, the American Joint Committee on Cancer (AJCC) recently incorporated the Oncotype DX test in its updated published Eighth Edition AJCC Cancer Staging Manual, identifying Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on prospective outcomes in more than 63,000 patients.

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 Recurrence Score®, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score™ predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With more than 700,000 patients tested in more than 90 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 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 help optimize cancer care by addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 700,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealthFacebookYouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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: our business model; the applicability of clinical study results to actual outcomes; the impact of results from clinical studies on market adoption and utilization of Oncotype DX® tests, our ability to develop and commercialize new tests and expand into new markets domestically and internationally; unanticipated costs or delays in research and development efforts; 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-K for the year ended December 31, 2016. 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, Genomic Health, Oncotype, Oncotype DX, Breast Recurrence Score, Recurrence Score, DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score, Oncotype AR-V7 Nucleus Detect and Oncotype IQ 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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