Genomic Health Announces Positive Results from Latest Clinical Validation Study of Oncotype DX® as Predictor of Near- and Long-term Outcomes in Racially Diverse Group of Prostate Cancer Patients

REDWOOD CITY, Calif., Sept. 29, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced strongly positive results from an additional independent clinical validation study of the Oncotype DX® prostate cancer test, conducted in collaboration with the Uniformed Services University of the Health Sciences' (USU) Center for Prostate Disease Research (CPDR) supported by a multi-disciplinary team of investigators under a cooperative research and development agreement with USU. This new large study reconfirmed the biopsy-based test's Genomic Prostate Score (GPS) as a predictor of adverse pathology at surgery and, for the first time, validated GPS as a strong independent predictor of a rise in prostate-specific antigen (PSA) following surgery (biochemical recurrence). In meeting these two endpoints, the Oncotype DX prostate cancer test provides both clinically actionable and long-term outcomes information for men with newly diagnosed low- and intermediate-risk prostate cancer. Furthermore, the study demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men.

The key results of this large prospectively-designed study in 402 patients are based on the CPDR multi-center national database, which has tracked men treated for prostate cancer within the Department of Defense healthcare system since 1990, and showed:

• The biopsy-based Oncotype DX GPS was a robust and independent measure of multiple clinically relevant endpoints, including adverse surgical pathology (p<0.001) and long-term risk of biochemical recurrence after surgery (p<0.001);
• The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian and African-American men regardless of their race. African-American men represented 20 percent of this study's patient population;
• The established multiple prostate cancer-specific pathways contributed to the robust predictive value of the Oncotype DX GPS.

The Oncotype DX GPS was also significantly predictive of metastatic prostate cancer recurrence (p = 0.032), a notable finding given the likelihood of metastases in patients with low- and intermediate-risk prostate cancer is so small.

"There is a clear need for more accurate risk stratification and treatment optimization of men with newly diagnosed prostate cancer," said senior author David McLeod, M.D., director of CPDR and a professor of Surgery at USU. "Our rigorously conducted study provides further validation of the earlier studies at Cleveland Clinic and University of California, San Francisco, which showed the Oncotype DX prostate cancer test is an independent predictor of clinical outcomes to inform decisions regarding active surveillance versus immediate treatment in patients with low- and intermediate-risk disease."

In this study, GPS results were obtained using archival biopsy tumor tissue from 402 men, including 82 African-American patients, treated with radical prostatectomy for NCCN very low-, low- or intermediate-risk prostate cancer at two U.S. military medical centers between 1990 and 2012. The analysis showed that GPS distribution was very similar between African-American and Caucasian patients. Additionally, specific gene groups incorporated in GPS – androgen signaling and stromal response – were more strongly associated with biochemical recurrence, while all four biologic pathways measured by GPS were significant predictors of adverse pathology.

The CPDR is a multi-disciplinary prostate cancer research program of the Department of Surgery at USU, the U.S. Department of Defense's federal health sciences university. The center is a collaboration with The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., a private,    not-for-profit organization authorized by Congress to support medical research and education at USU.

Developed and validated in collaboration with the University of California, San Francisco and Cleveland Clinic, the Oncotype DX prostate cancer test addresses the unique challenges in making treatment decisions for men with low-risk, clinically localized prostate cancer by identifying patients who can consider active surveillance with greater confidence and thus avoid unnecessary treatment, as well as those men who have more aggressive disease and should consider immediate treatment. This genomic test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. It provides a GPS result on a scale that ranges from 0 to 100, and is combined with other clinical factors to further clarify a man's risk prior to treatment intervention.  

"This new landmark study reconfirms the clinical validity of the Oncotype DX prostate cancer test and adds to the recently published UCSF and Cleveland Clinic studies," said Phil Febbo, M.D., chief medical officer, Genomic Health. "These new results provide the first validation of our test's ability to predict biochemical recurrence and a second, independent validation of its ability to predict adverse pathology. By measuring biology associated with both near- and long-term outcomes, the test provides important and practice-changing information to patients and physicians."

Additional Oncotype DX data presented at the ESMO 2014 Congress included previously presented studies in breast and renal cancers, highlighting further evidence of the impact of the Oncotype DX test in breast cancer treatment across multiple health care systems and the importance of assessing multiple, disease relevant, biological pathways to predict tumor behavior and the best course of treatment.

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 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 June 30, 2014, more than 19,000 physicians in over 70 countries had ordered more than 465,000 Oncotype DX tests.  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. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of the test to physicians and patients; the need for more accurate stratification and treatment optimization in the patient population; 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 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 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 June 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.