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Genomic Health: Oncology Surgeons Expedite Breast Cancer Treatment With Use of Oncotype DX(R) at Surgery or Biopsy


Published on 2009-09-03 13:49:30 - Market Wire
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REDWOOD CITY, CA--(Marketwire - September 3, 2009) - In an effort to provide breast cancer [ patients ] with prompt, critical information about treatment options for use at their first visit with the medical oncologist, a number of leading U.S. surgeons request [ Genomic Health's Oncotype DX ] molecular test at the time of surgery or biopsy.

[ Oncotype DX ] is a multigene expression test that analyzes the activity of 21 genes within a breast cancer patient's tumor to calculate an individualized result known as a [ Recurrence Score® ]. Additionally, the test report provides quantitative scores for certain individual genes. As of May 2009, physicians have used Oncotype DX for breast cancer treatment planning in more than [ 100,000 ] patients in over 40 countries worldwide. It is the only validated multigene expression test recommended in the treatment guidelines issued by both the American Society of Clinical Oncology [ (ASCO) ] and the National Comprehensive Cancer Network [ (NCCN) ].

"Obtaining these findings early on helps reduce a patient's anxiety about treatment and helps us ensure adherence to established quality-of-care indicators," says Harry D. Bear, MD, PhD, chairman, Division of Surgical Oncology and professor of Surgery and Microbiology & Immunology at the Virginia Commonwealth University School of Medicine & VCU Massey Cancer Center in Richmond.

Dr. Bear served as chair and moderator for the monograph entitled, "Oncotype DX Assay for [ Breast Cancer ]" in the August 2009 issue of [ Contemporary Surgery ]. The recommendations are based on his experience as a surgical oncologist and that of three other physicians from leading U.S. cancer centers.

The surgeon is often the first provider to discuss a breast cancer diagnosis and treatment plan with a patient. Ordering [ Oncotype DX early ] means results can be available for the patient's first consultation with the medical oncologist. To simplify the process further, some surgeons incorporate the test into standing orders established with the hospital's multi-disciplinary team.

"Although we may not determine adjuvant therapy, knowing a patient's Recurrence Score significantly focuses and simplifies my response to questions about needing chemotherapy. Now, I can tell a [ patient ] straightforwardly that we'll conduct a genomic analysis of her tumor to show how much she is likely to benefit from chemotherapy," said Pat Whitworth, MD, Director of the Nashville Breast Center and faculty member for the monograph.

Genomic Health provided financial support for the monograph as well as the roundtable discussions that served as the basis for the monograph.

About Oncotype DX®

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 [ 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 May 2009, more than 8,000 physicians have ordered more than 100,000 tests in over 40 countries, and both Medicare and private health plans covering over 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 applicability of clinical study results to actual outcomes, the ability of Oncotype DX to reduce anxiety about treatment and to ensure adherence to quality-of-care indicators, 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 June 30, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

Links to third-party websites or pages are provided for convenience only. Each website is subject to its own terms of use, and we encourage you to consult these policy statements. Genomic Health has no control over third party sites and does not endorse or recommend these sites, and expressly disclaims any responsibility for the accuracy of content or opinions set forth in any third party website or your use of that information. In addition, Genomic Health disclaims all liability arising out of allegations that third party content infringes the intellectual property rights of any person. Information in this release should not be considered medical advice. Patients should consult their doctor to determine the appropriate treatment decision for their individual disease.

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.

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