Genomic Health Announces Data Reinforcing Robustness of Oncotype DX® Prostate Cancer Test at 2014 American Urological Association (AUA) Annual Meeting

New Analysis Suggests Oncotype DX Predicts Recurrence Risk After Prostatectomy Regardless of Post-Surgery Treatment

PR Newswire

REDWOOD CITY, Calif., May 20, 2014 /PRNewswire/ -- Genomic Health, Inc. (GHDX) today presented positive results reinforcing the robustness of the Oncotype DX® prostate cancer test's development as a predictor of prostate cancer aggressiveness. A sub-analysis of a large Oncotype DX Genomic Prostate Score (GPS) development study, presented at the American Urological Association (AUA) Annual Meeting on May 20 in Orlando, suggests that GPS predicts time to clinical progression regardless of the treatment received following surgery.

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"These new data highlight the robustness of the assay, which was specifically developed and validated to address the critical treatment question for the hundreds of thousands of men who are diagnosed with low-risk prostate cancer and are likely candidates for active surveillance," said Eric A. Klein, M.D., chairman, Glickman Urological and Kidney Institute, Cleveland Clinic, and principal investigator for the Cleveland Clinic's original development studies. Dr. Klein is a paid consultant for Genomic Health.  "Furthermore, the ability of various genes within the GPS and across biological pathways to predict outcomes showcases the sensitivity of the assay." 

This exploratory analysis from one of the original development studies looked at a subset of 185 prostate cancer patients who experienced biochemical recurrence after surgery. These patients were analyzed in three subgroups based on treatment received at time of biochemical recurrence: men who did not receive additional treatment, men who received hormonal therapy and men who received radiation therapy.  Results showed that the Oncotype DX Genomic Prostate Score was predictive of clinical recurrence for all patients, regardless of the type of treatment patients received. For each therapy subgroup, different biological pathways within the GPS were most highly associated with patient outcome.

"Building on the portfolio of development and validation studies establishing GPS as an important test to help men with very-low, low- or intermediate-risk prostate cancer, this additional analysis highlights the importance of including multiple biological pathways to measure the aggressiveness of the disease," said Phil Febbo, M.D., chief medical officer, Genomic Health. "By incorporating genes from four critical pathways that drive prostate cancer behavior, Oncotype DX is a truly personalized test that predicts disease aggressiveness and addresses the challenges of biopsy under-sampling."  

As Genomic Health expands its focus on furthering understanding of prostate cancer biology, the company will continue to explore potential future applications of Oncotype DX to predict specific therapy benefit.

About Genomic Health

Genomic Health, Inc. (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 screening and surveillance, through diagnosis, treatment selection and monitoring.  Genomic Health's lead 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 and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS).  In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of March 31, 2014, more than 19,000 physicians in over 70 countries had ordered more than 440,000 Oncotype DX tests.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit:, and

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's intent to continue its investment to capture significant opportunities in the international and prostate markets; the company's expectations regarding reporting study results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests or indications in the future. 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 or indications 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 annual report on Form 10-Q for the period ended March 31, 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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