New Data Support Prostate Cancer Test Development Program
REDWOOD CITY, Calif., Feb. 3, 2012 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a large clinical study in prostate cancer evaluating the relationship of microRNAs, a novel class of biomarkers, to clinical outcomes for patients with early-stage prostate cancer. The data, presented at the 2012 Genitourinary (GU) Cancers Symposium, contribute to a greater understanding of prostate cancer biology by assessing the ability of specific microRNAs and genes to predict aggressive disease as part of the company's prostate cancer research and development program.
"In addition to supporting our development of a genomic prostate cancer assay to improve discrimination of clinically significant from insignificant prostate cancer, this study also demonstrates our innovative approach to provide a more comprehensive evaluation of biomarkers in the context of the known tumor heterogeneity of prostate cancer, one of the critical challenges faced by a biopsy-based clinical test for prostate cancer," said Steven Shak, M.D., chief medical officer of Genomic Health. "We remain committed to conducting multiple, well-designed prostate cancer studies in order to expand scientific knowledge about the disease and help physicians deliver better outcomes for their patients."
In the research presented at the 2012 GU Cancers Symposium, investigators analyzed 416 prostate cancers from patients treated with radical prostatectomy (RP) at Cleveland Clinic between 1987 and 2004. Modified RT-PCR methodology was used to assess 76 microRNAs, a distinct class of biological regulators that are very small, averaging about 22 nucleotides in length.
Dr. Klein and the Cleveland Clinic have also recently completed a study evaluating whether the expression of key genes and gene groups previously identified in radical prostatectomy specimens can be similarly predictive of aggressive prostate cancer when assessed in the small tissue volumes found in prostate needle biopsies. These results are planned for presentation at the 2012 American Association of Genitourinary Surgeons meeting in April.
"Treatment decisions for men with localized prostate cancer could be improved with more accurate knowledge at the time of diagnosis for the individual patient, including likelihood of favorable features such as low grade, organ-confined disease or low probability of tumor recurrence," said Eric Klein, M.D., chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. "These results advance our knowledge about prostate cancer and contribute to a broader effort aimed at the development of an actionable and validated genomic test that could arm physicians with additional information to help inform the patient care plan and allow us to avoid overtreatment of clinically insignificant cancers."
Separately, Genomic Health has initiated a clinical validation study for its prostate cancer test and plans to announce topline results later this year. The ongoing clinical validation study, being performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), is designed to determine if a multi-gene test can help patients with early stage prostate cancer by distinguishing aggressive disease requiring immediate treatment, such as surgery, from indolent disease which may be appropriately managed with active surveillance. The study will utilize Genomic Health's proprietary RT-PCR process for analyzing very small amounts of formalin-fixed paraffin-embedded (FFPE) prostate tissue obtained by diagnostic prostate needle biopsy. If positive, the clinical validation study results are expected to support the launch of the Oncotype DX® prostate cancer test in 2013.
"Identification of Prostate Cancer-Expressed MicroRNAs Associated with Clinical Recurrence (cR) and Prostate Cancer Specific Survival (PCSS) Following Radical Prostatectomy (RP)" (Abstract #21) was presented during the general poster session on Feb. 2.
Three leading medical specialty societies co-sponsor the three-day, multidisciplinary symposium, including the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global cancer company focused on the development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its 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 the 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 multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. As of December 31, 2011, more than 10,000 physicians in over 65 countries had ordered more than 265,000 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 the clinical utility of microRNA's as biomarkers for early stage prostate cancer; our ability to generate similar results in further studies; our ability to develop and launch a test for prostate cancer in 2013; the ability of any tests the company may develop to optimize cancer treatment; 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 company's tests to impact clinical practice and; the ability of the company to successfully 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 risk that study results may not be replicated in future studies; the applicability of clinical study results to actual outcomes; the risks associated with market expansion and the commercialization of current and future products; the risks and uncertainties associated with possible additional regulation of our tests both in the United States and abroad; the risks associated with competition; the risks that our products may infringe the intellectual property of third parties; 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, 2011. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
SOURCE Genomic Health, Inc.