Updates Progress on Oncotype DX Colon Cancer Test
REDWOOD CITY, Calif., Jan. 10, 2011 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced it will accelerate its prostate cancer clinical development program with the goal of launching a test globally in 2013, previously planned for launch in 2014, in light of positive top-line results of a large gene identification study which were presented in December at the Society for Urologic Oncology (SUO) annual meeting. Genomic Health and its research partners from Cleveland Clinic plan to present complete data at the ASCO Genitourinary Cancer Symposium and the United States & Canadian Academy of Pathology (USCAP) annual meeting in February 2011.
Developing a test that can address a critical dilemma in today's standard of care in prostate cancer will require well-designed clinical studies with reproducible evidence and the ability to work with very small amounts of biopsy tissue. As with Genomic Health's development of the Oncotype DX® breast and colon cancer tests, the company expects to conduct multiple clinical studies to establish the clinical utility of its prostate cancer test.
The company also announced that it secured reimbursement for its Oncotype DX colon cancer test from Clalit, the largest insurer in Israel covering 65 percent of the population, and expects to report results from a second recurrence study in stage II colon cancer in 2011.
Kim Popovits, Genomic Health's Chief Executive Officer, will provide a business update today at 3:30 p.m. at the 29th Annual JP Morgan Healthcare Conference highlighting the company's priorities for 2011. Ms. Popovits will be joined at the conference by the management team of Genomic Health, which includes Dean Schorno, who has been named as the company's Chief Financial Officer. Mr. Schorno was previously the Senior Vice President of Finance and has served with the company for nine years in various capacities, including managing the launch and operations of Genomic Health's clinical laboratory as Vice President, Operations. This appointment enables Brad Cole, Chief Operating Officer, who previously held both the COO and CFO roles, to expand his focus on the company's growing global business.
To access the live and subsequently archived webcast of the presentation, visit the Investor Relations section of Genomic Health's website at http://investor.genomichealth.com. Please connect to the website at least 15 minutes prior to the beginning of the presentation to allow for any necessary software downloads. An archived replay will be available for three months beginning 24 hours after the live presentation.
About 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 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 early-stage breast cancer. 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 September 30, 2010, more than 10,000 physicians in over 55 countries had ordered more than 175,000 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 stages of 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.
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 expectations regarding the timing of any launch of a prostate cancer test, the belief that previously presented study data could lead to the development of a multi-gene diagnostic test to predict aggressiveness of disease in prostate cancer patients, the company's expectations as to the clinical utility of its prostate cancer test in development, the belief that our prior development and commercialization strategy can be applied to a test for prostate cancer, the reproducibility of initial study results, our intent and ability to accelerate our clinical development efforts, the timing of presentation of results from our second colon cancer recurrence study, the applicability of clinical study results to actual outcomes, our beliefs regarding the prerequisites necessary to develop a test for prostate cancer, and our expectations regarding future growth of the company's business. 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.