REDWOOD CITY, Calif. and BARCELONA, March 25 Genomic Health, Inc. (Nasdaq: GHDX) today announced that the company has entered into an exclusive agreement with Palex Medical S.A., one of Europe's leading distributors of medical device and diagnostic services to hospitals, to distribute its Oncotype DX® breast cancer test in Spain and Portugal. The distribution agreement, announced in conjunction with positive data presented today at the 7th European Breast Cancer Conference (EBCC), further expands the global presence of Oncotype DX, providing for increased physician and patient access to this advanced diagnostic test in the European market.
"As the Oncotype DX breast cancer test gains recognition as standard of care in the U.S., our commitment to deliver its benefits to patients around the world continues to grow," said Jim Vaughn, Vice President International Sales and Marketing, Genomic Health. "We believe this relationship with Palex will make Oncotype DX more widely available to physicians and patients in Spain and Portugal."
The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate a Recurrence Score® result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients. In addition, in January 2010, Genomic Health launched its Oncotype DX colon cancer test, the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer.
"The Oncotype DX breast cancer test is supported by robust clinical evidence confirming its beneficial role in providing valuable insight beyond traditional measures to help guide treatment decisions for individual breast cancer patients," said, Dr. Xavier Carbonell, CEO of Palex Medical S.A. "This agreement complements Palex's commitment to bring personalized medicine to our customers in Spain and Portugal."
New Data Presented at EBCC Reinforce Clinical Benefits of Oncotype DX Breast Cancer Test
Additionally, Genomic Health presented findings from two studies, which further highlight the clinical utility of Oncotype DX in determining recurrence risk and chemotherapy benefit in early-stage, estrogen receptor-positive breast cancer patient populations. Highlights from the two studies, which were featured as poster presentations today at EBCC in Barcelona, include:
As of December 2009, more than 8,000 physicians had ordered more than 135,000 Oncotype DX breast cancer tests in more than 55 countries. The test was launched in the United States in 2004 where it has since been widely adopted, and it is currently offered for sale worldwide through various exclusive distribution agreements.
About Oncotype DX®
The Oncotype DX breast cancer test is the only multigene 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 test has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, 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 December 2009, more than 8,000 physicians in over 55 countries had ordered more than 135,000 tests, and both Medicare and private health plans covering over 90 percent of U.S. insured lives provided reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive 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 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 the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health launched its Oncotype DX colon cancer test in January 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
About Palex Medical
Palex Medical S.A. is one of the leading companies in the distribution of medical devices in the Spanish and Portuguese markets. With a history spanning more than 55 years, Palex is structured in two Business Areas, which contain a total of 10 divisions, and provides the widest range of products and services, covering from exploration gloves to robotic surgery. At present, Palex is making significant contributions to the fields of telemedicine, remote presence and robotization of surgery and oncology, especially in the field of diagnosis and treatment of tumors, also in robotic systems for the preparation of intravenous admixtures and cytostatics in pharmacy and others. For more information, please visit www.palexmedical.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 belief that the distribution agreement with Palex will make the test more widely available in Spain and Portugal; the company's belief that its commitment to deliver the benefits of the Oncotype DX test to patients outside of the U.S. will continue to grow; the belief that the study data further highlight the clinical utility of the test, and illustrate that the Oncotype DX Recurrence Score result incorporates additional important pathways beyond ER that provide clinically meaningful information; and the applicability of clinical study results to actual outcomes. 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 company's ability to increase usage of its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its existing tests and any future tests it may develop; the company's success retaining current contracts or levels of reimbursement coverage for its tests; our ability to compete against third parties; the company's ability to develop and commercialize new tests; unanticipated costs or delays in research and development efforts; the ability to obtain capital when needed; the company's history of operating losses; 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 Annual Report on Form 10-K for the year ended December 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.
-- An analysis (abstract 387) which examined the frequency of low estrogen receptor (ER) positive breast tumors in patients with low Oncotype DX Recurrence Score® results in Europe and the Middle East. The study demonstrated that numerous low ER-positive tumors have low Recurrence Scores. Patients with tumors that fall into this category exhibit a good prognosis and minimal, if any, chemotherapy benefit. These results build upon previous results and illustrate that the Recurrence Score incorporates other important biological pathways beyond ER that provide clinically meaningful information. -- A study (abstract 386) which showed that the less common histologic subtypes of invasive, ER-positive breast cancer are characterized by different gene expression profiles as measured by the Oncotype DX test. The study provided additional evidence that Oncotype DX for breast cancer is a useful tool for characterizing the biology of a tumor.
SOURCE Genomic Health, Inc.