Genomic Health Announces Positive Results From Large Prostate Cancer Gene Identification Study; Company to Proceed With Full Clinical Development

REDWOOD CITY, Calif., Dec. 9, 2010 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced the first results of a large prostate cancer study that identified 295 genes strongly associated with clinical recurrence following radical prostatectomy.  Top-line findings from this study, which applied the same RT-PCR technology used in Genomic Health's Oncotype DX® breast and colon cancer tests, will be presented today at the Society for Urologic Oncology (SUO) annual meeting.  The Company and its research partners from Cleveland Clinic plan to present complete data at the ASCO Genitourinary Cancer Symposium in February 2011.

"We have reached an important milestone in our clinical development of a test for prostate cancer by narrowing down specific genes and pathways that predict prostate cancer aggressiveness," said Steven Shak, chief medical officer at Genomic Health.  "Developing a test that can address a critical dilemma in today's standard of care will require well-designed clinical studies with reproducible evidence and the ability to work with very small amounts of biopsy tissue.  These study results give us confidence to move forward with full clinical development, and we are evaluating the opportunity to accelerate these efforts with our scientific advisors."

Researchers analyzed RNA from 431 prostate cancers among patients previously treated with radical prostatectomy (RP) at Cleveland Clinic between 1987 and 2004. Of the 732 cancer-related and reference genes assessed, 295 were significantly predictive (unadjusted p<0.05) of clinical recurrence-free interval (cRFI) using Cox PH regression.  The number of genes predicting clinical recurrence was well in excess of that expected by chance alone.  In addition, the majority of these 295 genes were strongly associated with additional endpoints including prostate-specific antigen (PSA) recurrence (75% of the genes); prostate cancer-specific survival (84% of genes) and upgrading/upstaging from biopsy to RP (68% of the genes).  Increased expression of cytoskeleton genes (i.e. FLNA) and epithelia genes (i.e. KRT5) were associated with lower risk of recurrence; whereas increased expression of extracellular matrix genes (i.e. COL3A1) were associated with higher risk of recurrence.

"Using a standardized quantitative technique combined with rigorous central review of pathology and clinical data, this study clearly demonstrates a strong association between tumor gene expression and clinical recurrence," said Eric Klein, M.D., Chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic.  "A genomic test that distinguishes between clinically indolent and aggressive disease could help men with localized prostate cancer and their doctors decide between active surveillance and immediate prostatectomy or radiation therapy, or decide on the need for adjuvant therapy after initial treatment.  We are very encouraged by these first results and look forward to presenting the complete data early next year."

Prostate cancer is the most common type of non-skin cancer found in American men and is the second leading cause of cancer death in men. The American Cancer Society estimates that there will be about 217,730 new cases of prostate cancer in the United States this year.

About Genomic Health Genomic Health

Genomic Health, Inc. (NASDAQ: GHDX) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. As of September 30, 2010, more than 10,000 physicians in over 55 countries had ordered more than 175,000 Oncotype DX tests. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the study data could lead to the development of a multi-gene diagnostic test to predict aggressiveness of disease in prostate cancer patients and possibly aid in the identification of patients whose prostate cancer could be managed with active surveillance versus those who  could most benefit prostatectomy and/or radiation therapy, or adjuvant therapy after initial treatment, the belief that our prior development and commercialization strategy can be applied to prostate cancer, the reproducibility of study results, our intent and ability to accelerate our clinical development efforts, 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; 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, 2010. 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 and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

SOURCE Genomic Health, Inc.