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- Guidelines Specify that Validated Molecular Assays Should be Considered as an Adjunct to Standard Measures in Helping Determine Chemotherapy Benefit -
Genomic Health, Inc. (Nasdaq: GHDX) today reported that the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer recommended for the first time that validated multigene assays, such as Oncotype DX(R), should be considered as an adjunct to standard measures in helping determine chemotherapy benefit for early-stage breast cancer patients. These new treatment guidelines, published online in the cancer journal, Annals of Oncology, represent a significant advancement for the role of validated molecular diagnostics in breast cancer treatment planning and selection in Europe.
According to the guidelines, the threshold for recommending chemotherapy in treating estrogen receptor (ER) positive, HER2-negative breast cancer is difficult to define. Clinical research in the United States and other countries shows that information obtained from multigene assays, including Oncotype DX, leads to a change in treatment decisions in approximately 30 percent of cases. Physicians from more than 40 countries currently use Oncotype DX to predict the likelihood of chemotherapy benefit as well as the likelihood of recurrence for patients with early stage breast cancer, in order to make individualized treatment decisions about the addition of chemotherapy to hormonal therapy.
Oncotype DX was launched in the United States in 2004 where is has since been widely adopted as standard of care for treating early-stage breast cancer. Oncotype DX is the only validated multigene expression assay recommended in both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) guidelines, and extensively reimbursed in the United States. To date, physicians have used Oncotype DX for breast cancer treatment planning in more than 100,000 patients in over 40 countries worldwide.
"We are pleased that the prestigious St. Gallen International Consensus recognizes the benefit that validated genomic tests, such as Oncotype DX, can offer to patients diagnosed with early stage breast cancer," said Gary Palmer, Vice President of Medical Affairs, Genomic Health. "We believe these guidelines support the expansion of Oncotype DX in the European market and should help establish favorable reimbursement policies, making our test readily available for physicians and patients in this important region."
Aiming to provide evidence-based, scientifically valid recommendations for the treatment of early breast cancer in clinical practice, the St. Gallen consensus guidelines are determined bi-annually by a panel of more than 30 breast cancer experts from around the world. This is the first time that a European body of experts has supported the use of a validated multigene-profiling assay as an adjunct to high-quality phenotyping of breast cancer in cases where the indication for adjuvant chemotherapy is uncertain.
"These new guidelines provide further evidence that the international clinical community sees the value of advanced molecular diagnostics in helping make more informed, individualized breast cancer treatment decisions," said Dr. Joseph Gligorov, Tenon Hospital, Paris. "More patients for whom the prognostic evaluation is still uncertain with the classical and optimal pathological tools, should now be offered the opportunity to benefit from these new tests, as it provides both physicians and patients with valuable, accurate information about their individual cancer and greater confidence in treatment selection."
About Oncotype DX(R)
The Oncotype DX breast cancer assay 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 assay 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. To date, more than 8,000 physicians have ordered more than 100,000 tests in over 40 countries. United States government health plans, such as Medicare, and private insurance covering more than 90 percent of U.S. insured lives provide 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 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 is preparing to launch its Oncotype DX colon cancer test in early 2010. The company was founded in 2000 and is located in Redwood City, California. 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 belief that inclusion of the use of validated multigene assays such Oncotype DX in the St. Gallen guidelines supports the expansion of Oncotype DX in Europe, that inclusion of these types of tests in such guidelines may also help establish favorable reimbursement policies in Europe, 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 risk that Oncotype DX may not receive adequate reimbursement coverage in Europe, risks associated with international operations, 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.
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