Genomic Health Announces Publication of Oncotype DX® Prostate Cancer Test Analytical Validation Study

BMC Genomics Publishes Analytical Validation Showing Oncotype DX Overcomes the Challenges of Testing from Very Small Prostate Cancer Needle Biopsy Sample

PR Newswire

REDWOOD CITY, Calif., Nov. 22, 2013 /PRNewswire/ -- Genomic Health, Inc. (GHDX) today announced that BMC Genomics published positive results from its analytical validation study demonstrating that the Oncotype DX® prostate cancer test is a reliable assay, even with very limited RNA inputs, which enables successful performance using small amounts of cancer tissue typically available from prostate needle biopsies.  Conducted in collaboration with Cleveland Clinic, the aim of this study was to validate the accuracy of the Oncotype DX prostate cancer test by analyzing the test's precision and accuracy in measuring gene expression over a wide range of conditions commonly encountered with diagnostic prostate biopsies.

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"Our development studies successfully addressed the key challenges inherent in prostate cancer risk assessment, including tumor heterogeneity as well as biopsy under-sampling and under-staging," said Eric A. Klein, M.D., chairman, Glickman Urological and Kidney Institute at Cleveland Clinic and principal investigator for the Cleveland Clinic's original development studies. "To achieve this, we used an optimized RT-PCR platform to measure, analyze and compare gene expression in prostate cancer tissue samples taken from both radical prostatectomy and needle biopsy specimens." Dr. Klein has received research funding from Genomic Health and is a paid advisor and speaker for the company.

The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness.  The test results are reported as a Genomic Prostate Score (GPS) that ranges from 0 to 100 and is combined with other clinical factors, such as PSA and biopsy Gleason Score, to further clarify a man's risk prior to deciding on a treatment plan.  The positive results from a large validation study of this test led by the University of California, San Francisco were presented at the 2013 American Urological Association Annual Meeting. 

"With ten studies, including more than 1,100 patients, we continue to broaden our understanding of information provided by the recently launched Oncotype DX prostate cancer test, which was designed to improve treatment decisions to help address one of the largest issues in men's health today – overtreatment of low risk prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health and former professor of medicine and urology at the University of California, San Francisco.

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 September 30, 2013, more than 19,000 physicians in over 70 countries had ordered nearly 400,000 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 our ability to generate similar results in further studies; the ability of the Oncotype DX Prostate Cancer test to identify aggressive disease in small needle biopsy samples;  the applicability of clinical study results to actual outcomes; the ability of the company's tests to impact clinical practice ; the ability of the company to develop and commercialize additional tests in the future; and  the scope, success or results of clinical trials and the timing of such activities. 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 our tests; the risks associated with competition; the applicability of clinical study results to actual outcomes; the risks associated with the commercialization of current and future products; the risks and potential delays associated with such studies; 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, 2013. 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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