Genomic Health to Address One of the Most Significant Needs in Men’s Health with the Oncotype DX® Prostate Cancer Test
Complete Results from Positive Clinical Validation Study to be Presented at 2013 American Urological Association (AUA) Annual Meeting
Company to Make Oncotype DX Prostate Cancer Test Available to Physicians and Prostate Cancer Patients by End of Second Quarter
REDWOOD CITY, Calif., April 3, 2013 – /PRNewswire/ – Genomic Health, Inc. (Nasdaq: GHDX) today announced that the clinical trial results validating its biopsy-based Oncotype DX® prostate cancer test will be presented by investigators from the University of California, San Francisco (UCSF) in an oral session at the American Urological Association (AUA) Annual Meeting on May 8, 2013 in San Diego. The presentation will also include the results of previously conducted development studies lead by Cleveland Clinic where researchers evaluated more than 700 patients and 700 candidate genes to select the genes for this test.
The Oncotype DX prostate cancer test is designed to address one of the most significant needs in men’s health by providing physicians and patients with a new way to assess the aggressiveness of a man’s prostate cancer to enable a better informed course of care.
- AUA Oral Presentation Details:
- Date: Wednesday, May 8, 2013, 8:00-10:00 a.m. Pacific Time
- Oral Presentation: “Development and validation of the biopsy-based genomic prostate score (GPS) as a predictor of high grade or extracapsular prostate cancer to improve patient selection for active surveillance” (Abstract #2131)
- Presenter: Matthew R. Cooperberg, M.D., Assistant Professor of Urology; Epidemiology & Biostatistics, UCSF
- Session Title: Prostate Cancer: Markers (I)
- Location: San Diego Convention Center, 111 W. Harbor Drive, Room 1
Dr. Cooperberg and his colleagues at UCSF will present the important results of this independent, prospectively-designed clinical validation study that evaluated the Oncotype DX test in prostate needle biopsy specimens.
Based on these new findings, Genomic Health is completing the necessary work to make the Oncotype DX Genomic Prostate Score (GPS) available to physicians and patients by the end of the second quarter of 2013.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global healthcare company that provides actionable genomic information to personalize cancer treatment decisions. The company’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. As of December 31, 2012, more than 19,000 physicians in over 70 countries had ordered more than 335,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional treatment decisions in breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com and www.mybreastcancertreatment.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 plans to present the complete data from this study at the 2013 ASCO Genitourinary Cancers Symposium, the expected date on which our prostate cancer test will be available; the ability of any such test to individualize cancer treatment decisions for prostate cancer patients at the time of diagnosis; the potential of the test to change medical practice for some prostate cancer patients; the ability of the company to develop additional tests in the future; the scope, success or results of clinical trials and the timing of such activities; the applicability of clinical study results to actual outcomes; the ability of the test to impact clinical practice; the ability of the company to obtain and maintain adequate reimbursement for the test; our beliefs regarding the attributes of our product pipeline; and our ability to develop 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 results of clinical studies; the applicability of clinical study results to actual outcomes; the risks and potential delays associated with such studies; the risks, costs and potential delays associated with the commercialization of current and future products; unanticipated costs or delays in research and development efforts; risks and uncertainties associated with the regulation of and reimbursement for our tests, both domestically and abroad; our ability to compete against third parties; 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 Annual Report on Form 10-K for the year ended December 31, 2012. 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.