Genomic Health Announces Multiple Oncotype DX® Presentations at ASCO 2016 Showcasing Industry-leading Commitment to Bringing Precision Medicine to Cancer Patients

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June 5, 2016 at 8:00 AM EDT

Genomic Health Announces Multiple Oncotype DX® Presentations at ASCO 2016 Showcasing Industry-leading Commitment to Bringing Precision Medicine to Cancer Patients

REDWOOD CITY, Calif., June 5, 2016 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from seven Oncotype DX® studies being presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. Results include four new analyses from the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Registry with more than 44,600 breast cancer patients. The SEER analyses reconfirmed through prospective outcomes data that the Oncotype DX® Breast Recurrence Score™ is an accurate predictor of five-year survival in patients with node-positive and node-negative disease in contemporary "real-world" clinical practice and revealed disparities in Oncotype DX testing use and patient outcomes.

"The results of the new analyses of SEER Registry data reinforce the specific value of Oncotype DX in node-positive disease and in older women," said Steven Shak, M.D., chief scientific officer, Genomic Health. "These new data add to unprecedented evidence that Oncotype DX provides critical information to ensure improved patient outcomes and less harm, and should be recommended and used as standard of care in node-negative disease and certain patients with node-positive disease."

  • In node-positive disease, the Breast Recurrence Score added considerable additional independent prognostic value for five-year breast cancer survival when reported separately for patients with micrometastases, one, two or three positive nodes (Abstract 6575).
  • In node-negative disease, worse breast cancer survival was observed in older patients (over age 70) who were tested and had an intermediate or high Breast Recurrence Score result, contrary to the general perception that older women tend to have favorable outcomes. Patients age 70 or older also had lower reported chemotherapy use, supporting continued examination of the often reported issue of under-treatment of the elderly (Abstract 574).
  • The utilization of Oncotype DX in clinical practice significantly varied based on age, race, socioeconomic status, marital status, insurance, tumor grade, tumor size (p &#60 0.01 for each) and geographic location. Patient age and geographic location were particularly strong factors that influenced test use. Overall, about 40 to 50 percent of women who met the guideline criteria for Oncotype DX had the test, underscoring the opportunity to bring precision medicine to more patients (Abstract 6552, Abstract 6553).

"The results of this study demonstrate the potential of future data linkages to enhance the quality, completeness, and usefulness of the SEER data in supporting cancer research and our broadening understanding of the disease," said Lynne Penberthy, M.D., M.P.H., associate director of the Surveillance Research Program, NCI's Division of Cancer Control and Population Sciences.

Oral Presentation Highlights the Positive Impact of Oncotype DX on Quality of Care

Investigators at the University of Michigan assessed the clinical use of Oncotype DX and its impact on patient experiences in 1,527 invasive breast cancer patients. The study demonstrated that physician recommendations for chemotherapy and patient receipt of chemotherapy were consistent with Breast Recurrence Score results, including in patients with node-positive disease. The study results indicated that the use of Oncotype DX is a compelling model for how precision medicine can markedly improve decision making for treatment of cancer (Abstract 6501).

Other presentations reinforcing the value of Oncotype DX in personalizing cancer treatment included:

  • The five-year clinical outcomes results from the prospective Phase III PlanB trial, one of the largest contemporary adjuvant breast cancer trials in Europe, conducted by the West German Study Group (WSG). Results showed that patients with low Breast Recurrence Score results had 99 percent overall survival, consistent with conclusions from TAILORx (published in The New England Journal of Medicine) and results from the recently published NCI-SEER Registry study (Abstract 556).
  • Results of a study of Oncotype DX in prostate cancer showed that the Genomic Prostate Score was a strong predictor of biochemical and clinical recurrence in intermediate- and high-risk patients and thus appears to provide improved risk stratification in this patient population (Abstract 5049).

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. With more than 600,000 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, www.mybreastcancertreatment.org and  www.myprostatecancertreatment.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 cancer, 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 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. 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 regulation of our tests; 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 we may not obtain or maintain sufficient levels of reimbursement, domestically or abroad; competition; unanticipated costs or delays in research and development efforts; our ability to obtain capital when needed; and the other risks and uncertainties set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended March 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, Oncotype, Oncotype DX, Recurrence Score, DCIS Score, Oncotype SEQ, 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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