REDWOOD CITY, Calif., May 28, 2009 – Genomic Health, Inc. (Nasdaq: GHDX) today announced an important milestone in reaching a total of more than 100,000 patients with its Oncotype DX® breast cancer test since the test became available in 2004. Oncotype DX is the first and only gene expression test clinically validated to predict the likelihood of a patient’s benefit from chemotherapy, as well as risk of disease recurrence.
“At Genomic Health, we are dedicated to changing the way cancer is diagnosed and treated by providing patients and their physicians with individualized genomic information that can empower them to better manage their disease,” said Kim Popovits, president and CEO, Genomic Health. “With more than 100,000 patients having now benefited from information provided by our Oncotype DX test, it is encouraging to see personalized treatment decisions becoming standard practice for early-stage breast cancer patients. We look forward to continuing our work in bringing this approach to clinical practice for other cancers.”
Oncotype DX examines a breast cancer patient’s tumor tissue at a molecular level. The test determines the level of activity of 21 specific genes within a tumor and provides an individualized result known as a Recurrence Score® for women with early-stage breast cancer. The Recurrence Score result correlates with the likelihood that a patient’s breast cancer will return and also indicates whether they are likely to benefit from chemotherapy.
“I was diagnosed with breast cancer in 2003 and after a double-mastectomy, I was at a loss at how to move forward with treatment. I wanted to understand what treatment would be most beneficial to my individual disease,” said Katherine Young, podiatrist, certified ski instructor and the first woman to benefit from Oncotype DX. “The Oncotype DX test informed me that I had a low Recurrence Score, which gave me reassurance that I could avoid chemotherapy without increasing my risk of recurrence, ultimately allowing me to maintain my energetic, active lifestyle.”
In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health is preparing to launch the Oncotype DX colon cancer test in early 2010. The company recently announced positive results from the landmark QUASAR validation study, which demonstrated that the Oncotype DX colon cancer test, which is based on a different set of genes than the breast cancer test, can independently predict individual recurrence risk in stage II colon cancer patients following surgery.
About Oncotype DX®
The Oncotype DX breast cancer assay is the first and only multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Additionally, the test report provides quantitative scores for certain individual genes. The Oncotype DX breast cancer assay has been extensively evaluated in thirteen clinical studies involving more than 4,000 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. As of April 30, 2009, 7,500 physicians have ordered more than 100,000 tests, and both Medicare and private health plans covering more than 90 percent of U.S. insured lives provided reimbursement for Oncotype DX through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. For more information about Oncotype DX, please visit http://www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (Nasdaq: GHDX) 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, Oncotype DX®, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit http://www.genomichealth.com. The Web site features a new Perspectives section, which provides insight on important issues affecting the field of personalized medicine.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the applicability of clinical study results to actual outcomes and the company's plans to commercialize a test for colon cancer and the proposed timing of such commercialization. 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 potential delays associated with commercialization of a new test; the risks and uncertainties associated with the regulation of the company's tests; 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 March 31, 2009. 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.