European Urology Published Groundbreaking Results from Three Studies Demonstrating Genomic Health's Oncotype DX® Test Predicts Prostate Cancer Aggressiveness at Diagnosis

REDWOOD CITY, Calif., May 16, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) announced today that groundbreaking results from three studies of the Oncotype DX^® prostate cancer test were published in European Urology. The peer-reviewed publication highlights studies that focus on addressing the need of the large proportion of prostate cancer patients who are candidates for active surveillance. Results showed that the 17-gene Oncotype DX Genomic Prostate Score (GPS) is a significant predictor of disease aggressiveness at the time of diagnosis—before intervention with radiation or surgery—and provides more precise and individualized risk assessment beyond currently available risk factors to help physicians and their prostate cancer patients confidently choose the most appropriate treatment.

Developed and validated in collaboration with Cleveland Clinic and University of California, San Francisco (UCSF), the Oncotype DX prostate cancer test addresses the unique challenges of local prostate cancer diagnosis and treatment by revealing the underlying biology of the tumor and using genes from multiple biologic pathways to predict the aggressiveness of prostate cancer when diagnosed.

"Our extensive development studies addressed the key challenges inherent to prostate cancer and helped overcome tumor heterogeneity and biopsy under-sampling and under-staging to develop a prostate cancer test that improves risk assessment at the time of diagnosis," 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.

The two development studies performed at the Cleveland Clinic analyzed gene expression in prostate cancer tissue from both radical prostatectomy samples (441) and very small needle biopsy specimens (167). Out of more than 700 candidate genes, the final analysis yielded 17 genes from four biologic pathways that had strong analytic performance and predicted outcomes associated with aggressive prostate cancer, including clinical recurrence, biochemical recurrence, prostate cancer death and adverse pathology.

"Experience to date suggests that refining a man's risk for having adverse pathology using the Genomic Prostate Score, despite information such as biopsy grade and tumor volume that suggest less aggressive disease, helps them make the most appropriate choice between active surveillance and immediate definitive treatment," said Peter Carroll, M.D., M.P.H., professor and chair, Department of Urology, UCSF, and principal investigator of the validation study of the Oncotype DX GPS. "In our validation study, Oncotype DX significantly increased the number of patients who can more confidently consider active surveillance. Importantly, the GPS also identified a subset of patients who, despite seemingly low-risk clinical factors, had more aggressive disease, suggesting that they may want to consider immediate treatment and/or additional evaluation."

In the UCSF-led clinical validation study of diagnostic biopsies from 395 men who were candidates for active surveillance, the GPS predicted the presence of adverse pathology (defined as high-grade and/or high-stage disease) within the entire prostate prior to intervention (p=0.002). Importantly, GPS predicted adverse pathology (p<0.005) after controlling for established clinical factors such as PSA, biopsy Gleason Score and age in multivariable analysis. Finally, the use of GPS in conjunction with NCCN^® categories or CAPRA score was shown to significantly improve risk assessment and potentially increase the number of men who should consider Active Surveillance.

Each year, more than 210,000 U.S. men are diagnosed with prostate cancer based on their needle biopsies. However, the existing methods of examining the very small amounts of tissue obtained by needle biopsy under the microscope do not adequately predict whether more aggressive disease might remain in the prostate. This limitation has led most men to decide to treat prostate cancer immediately, despite a less than three percent chance of prostate cancer causing significant medical problems during their life.

"Each cancer has unique tumor biology that drives clinical behavior, and we have developed tests—each with distinct genes across multiple pathways—in order to address the most relevant questions for breast, colon and prostate cancer patients," said Phil Febbo, M.D., chief medical officer, Genomic Health. "We believe, that based on these findings, the use of GPS can potentially increase the number of men who could confidently choose active surveillance by 20 to 30 percent. For men with prostate cancer, the ability to more precisely define their individual risk of aggressive disease is a significant leap forward in precision cancer care."

The publication, titled "A 17-gene Assay to Predict Prostate Cancer Aggressiveness in the Context of Gleason Grade Heterogeneity, Tumor Multifocality, and Biopsy Undersampling," (Klein, Cooperberg, et al) was published online on May 16 in European Urology, an international journal with the highest impact factor in urology.

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 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, 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 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 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 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.

Logo - http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

SOURCE Genomic Health, Inc.