REDWOOD CITY, Calif., Oct. 22 /PRNewswire-FirstCall/ -- Genomic Health, Inc. today reported that the company’s Oncotype DX(TM) breast cancer assay, used to predict the likelihood of disease recurrence and likelihood of chemotherapy benefit for node-negative, estrogen receptor-positive breast cancer patients, has been included in updated guidelines on the use of breast cancer tumor markers by the American Society of Clinical Oncology (ASCO). The inclusion of Oncotype DX in ASCO’s updated clinical practice guidelines represents a significant step forward for the role of molecular diagnostics in breast cancer treatment planning. These guidelines were published online today in the Journal of Clinical Oncology and will appear in the journal’s November 20th print edition.
“We are delighted that ASCO, the leading professional organization representing physicians who treat people with cancer, has recommended the use of Oncotype DX and differentiated it as an optimal tool for breast cancer treatment selection,” said Steve Shak, M.D., chief medical officer at Genomic Health. “Physicians have used Oncotype DX for treatment planning in more than 33,000 patients. We believe this, in addition to the new ASCO Guidelines and extensive reimbursement, indicates that the use of Oncotype DX is becoming standard practice for physicians and women making individual breast cancer treatment decisions.”
The inclusion of Oncotype DX in ASCO’s updated clinical practice guidelines is based on multiple independent clinical 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. ASCO Guidelines serve as a guide for doctors and outline appropriate methods of treatment and care.
“It’s important to note that ASCO’s new guidelines only include markers with a proven clinical decision-making impact that are based on a high level of clinical validation,” said Gabriel N. Hortobagyi MD, FACP, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center. “While exciting research and multiple prognostic tools are available today, Oncotype DX is the only genomic test that has sufficient clinical evidence to support its use in clinical practice.”
About Oncotype DX
Oncotype DX is the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of breast cancer survival 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. To date, over 6,000 physicians have ordered a cumulative total of more than 33,000 tests and approximately 125 million lives are now covered by reimbursement contracts and agreements. For more information about Oncotype DX, please visit http://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 a large portion of early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit http://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 beliefs about the advancement of the role of molecular diagnostics in breast cancer treatment, the belief that the use of Oncotype DX is becoming standard practice in the treatment of women with certain types of breast cancer, and the factors driving the use of Oncotype DX in treatment decisions. 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 applicability of clinical results to actual outcomes; the ability of our test to continue to impact treatment decisions; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risks and uncertainties associated with the regulation of our test by FDA; our ability to obtain capital when needed; our history of operating losses; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the six months ended June 30, 2007. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements. NOTE: Genomic Health, 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.
CONTACT: Investors, Brad Cole, +1-650-569-2281,
investors@genomichealth.com; or Media, Emily Faucette, +1-415-595-9407,
media@genomichealth.com, both of Genomic Health, Inc.
Web site: http://www.genomichealth.com/
http://www.oncotypedx.com/
