Oncotype DX® Predicts Outcomes in Prostate Cancer Patients, Significantly Changes Treatment Recommendations

Studies Presented at the 2014 Society of Urologic Oncology Annual Meeting Demonstrate Test's Value to Physicians and Patients, Support Increased Adoption and Reimbursement

Clinical Validation Study Now Published in European Urology

Dec 03, 2014, 08:00 ET from Genomic Health, Inc.

REDWOOD CITY, Calif., Dec. 3, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from two studies of the Oncotype DX® prostate cancer test demonstrating its value in low- and intermediate-risk prostate cancer to enable physicians and patients to avoid over- and under-treatment of the disease.  Both studies will be presented today, December 3, at the Society of Urologic Oncology (SUO) Annual Meeting, in Bethesda, Md. 

Results from the latest clinical validation study, published in European Urology this month online, show that the Oncotype DX test predicts near- and longer-term outcomes in a racially diverse group of men with clinically localized prostate cancer.  The analyses, conducted in collaboration with the Uniformed Services University of the Health Sciences' Center for Prostate Disease Research (CPDR), reconfirmed the biopsy-based Oncotype DX prostate cancer test as a predictor of whether adverse pathology would be found if the prostate were removed by surgery.  Additionally, for the first time, the Oncotype DX prostate cancer test was validated as a strong independent predictor of biochemical recurrence, which is a rise in PSA following surgery.  Furthermore, the study, in which 20 percent of patients were African-American men, demonstrated that Oncotype DX is similarly predictive of outcomes in both Caucasian and African-American men.

"Our recently conducted survey of African-American men showed that more than 70 percent think prostate cancer is best treated immediately and that their loved ones would want them to do so," said Thomas A. Farrington, founder and president of the Prostate Health Education Network (PHEN).  "These statistics highlight a significant potential for prostate cancer over-treatment and underscore the need for more knowledge about genomic tests like Oncotype DX, which provides a scientifically precise assessment of each patient's prostate cancer aggressiveness, and can help relieve the anxiety experienced by men and their families in making the proper treatment decision."

"Each year, 240,000 men are diagnosed with prostate cancer in the Unites States alone.  Importantly, more than half of these men have low-risk disease and can be candidates for active surveillance," said Phil Febbo, M.D., chief medical officer, Genomic Health. "With eleven prostate cancer studies in more than 1,500 patients, Genomic Health has developed and validated the only genomic test that has met the most actionable endpoint of adverse pathology, giving physicians the confidence to put many low- to intermediate-risk patients on active surveillance, while identifying those patients who might be missed by conventional measures and could benefit from more aggressive treatment."

Separately, the results of the first Oncotype DX prostate cancer test decision impact study showed that the use of the test significantly changed treatment recommendations.  Conducted in collaboration with academic and community practices at Columbia University, Delaware Valley Urology and Orange County Urology, this prospective study in a contemporary population of men with low- or intermediate-risk disease showed that the use of the test substantially increased the number of men who would be eligible for active surveillance.  Additionally, use of the test increased physician confidence in their treatment recommendations.

"Prostate cancer comes in many different forms and having confidence in your treatment recommendation and decision is crucial," said Ketan K. Badani, M.D., lead investigator of the study and vice chairman of Urology and Robotic Operations at Mount Sinai Health System, New York.  "Nearly half of prostate cancer is not aggressive and now we have more advanced tools like genomic profiling with the Oncotype DX test to determine a man's individual risk."

The complete results of this first Oncotype DX clinical utility study in prostate cancer have been accepted for publication in Urology Practice, an official journal of the American Urological Association. 

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 Oncotype DX prostate cancer test identifies low- to intermediate-risk patients eligible for active surveillance, as well as those who may benefit from immediate invasive treatment by predicting disease aggressiveness.

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 prostate cancer test, visit: www.OncotypeDX.com or 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 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 ability of the company's prostate cancer test to significantly change treatment decisions; 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; and the applicability of clinical study results to 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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