REDWOOD CITY, Calif., Jan. 8 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today announced that it will move one of its research projects, a test to predict the likelihood of colon cancer recurrence, into full-scale clinical development. This is the second major cancer program initiated by the company, and the company intends to follow a similar clinical development path as it did for its Oncotype DX breast cancer assay.
The colon cancer program is expected to build upon genes associated with prognosis in patients with stage II and III colon cancer treated with surgery, which were identified earlier last year in collaboration with the National Surgical Breast and Bowel Project (NSABP). Results from a gene identification study presented by Genomic Health at last year's annual meeting of the American Society of Clinical Oncology (ASCO) demonstrated a strong correlation between gene expression and colon cancer recurrence.
"As with Oncotype DX, we intend to follow a rigorous clinical development path, conducting multiple studies to refine the relevant gene panel with the goal of validating a reliable colon cancer test service that quantifies recurrence risk and helps individualize and improve treatment decisions," said Steve Shak, M.D., chief medical officer of Genomic Health.
Genomic Health initiated colon cancer studies with the National Surgical Breast and Bowel Project (NSABP) in 2006 and is coordinating additional studies with multiple clinical partners who have access to clinical samples. The company plans to evaluate its new test in more than 3,000 patient samples through these collective studies, with the goal of making the colon cancer test service available in 2009, depending on certain variables. In addition, Genomic Health plans to conduct multiple clinical studies to support expanding the utility of its current Oncotype DX test service for breast cancer, including usage in node-positive patients.
As previously announced, Genomic Health's Chairman and Chief Executive Officer, Randy Scott, will present at the 25th Annual JP Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 10 at 1:30 p.m. Pacific Time. 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 Oncotype DX
Oncotype DX represents the first diagnostic multi-gene expression test service commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 2,600 breast cancer patients, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. is a life science company focused on the 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 its first test service, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the intended clinical development path of a potential colon cancer test, the attributes of any such test, the outcome of clinical studies designed to validate test results, the ability of Genomic Health to successfully commercialize any future test or to expand the utility of any current or future test, our expectations with respect to the availability of any future test, and our ability to conduct additional clinical studies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: the high degree of risk associated with the clinical development of new genomic tests and with clinical trials, the results of further research and development, our ability to obtain access to adequate numbers of tissue samples, uncertainties associated with the regulation of our test or any future tests by FDA, our ability to complete against third parties, unanticipated delays or cash requirements and the other risks set forth in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006. 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.
Genomic Health, Inc.CONTACT: Media: Emily Faucette, +1-415-595-9407, media@genomichealth.com,Investors: Brad Cole, +1-650-569-2281, investors@genomichealth.com
