Genomic Health Demonstrates the Importance of Utilizing Multiple Biological Pathways to Predict Tumor Behavior in Prostate and Renal Cancers

REDWOOD CITY, Calif., June 3, 2014 /PRNewswire/ -- Genomic Health, Inc. GHDX today announced results of two studies demonstrating the ability of its Oncotype DX^® test and a new 16-gene panel to predict disease aggressiveness and clinical outcomes in prostate and renal cancers, respectively. These results, presented at the American Society of Clinical Oncology^® (ASCO^®) Annual Meeting in Chicago, underscore the company's successful approach to understanding tumor biology, resulting in tests that incorporate distinct genes across multiple pathways to provide more precise risk assessment than currently available risk factors and help improve treatment decision making.

"Based upon our extensive experience across cancers, we have observed that each cancer has a unique set of genes with expression that is most strongly associated with outcome," said Phil Febbo, M.D., chief medical officer, Genomic Health. "Our approach in breast, colon, prostate cancers – and now, in renal cancer – reflects our ability to select those genes and pathways that can inform critical treatment decisions and individualize patient care."

In the prostate cancer study, researchers at the University of California, San Francisco (UCSF) conducted an analysis of 395 patient samples to evaluate the ability of the Oncotype DX Genomic Prostate Score (GPS) to predict cancer aggressiveness despite variability in pathology assessment. The analysis revealed that original pathology readings of tumor grade and stage, rendered by more than 15 pathologists, frequently differed from the central review that was performed by a single expert urologic pathologist as part of the clinical validation study. For both biopsy and radical prostatectomy specimen evaluation, the pathology results for Gleason Score were different in one out of every four patients (24 percent and 26 percent, respectively). Despite these discordances, GPS remained a robust predictor of adverse pathology at surgery.

"These results demonstrate that the Oncotype DX GPS remains prognostic of disease aggressiveness in the face of differing pathology assessments," said Matthew Cooperberg, M.D., assistant professor of urology, epidemiology and biostatistics, UCSF.  "This test measures the heterogeneous biology of prostate cancer and represents a personalized approach to predict disease aggressiveness."  

Separately, an independent, prospectively conducted study provided clinical validation of a 16-gene signature developed by Genomic Health to predict disease recurrence after surgery in patients with clear cell renal cell carcinoma (ccRCC). A consortium of French researchers conducted an analysis of 626 patients who were treated with surgery and then followed for a median of five and a half years. They demonstrated that the 16-gene panel was able to predict clinical outcomes in patients with stage I, II and III ccRCC and provide significant information beyond conventional clinical and pathologic characteristics. This panel includes genes from four pathways: vascular, immune response, cell growth and division, and inflammation. It was developed as part of a collaboration agreement with Pfizer, Inc. and could potentially be useful in guiding treatment as effective adjuvant therapies emerge.

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, 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, renal 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 quarterly 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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SOURCE Genomic Health, Inc.