SOURCE: Genomic Health, Inc.

Genomic Health, Inc.

October 11, 2010 08:00 ET

Genomic Health Announces Analysis From First European Clinical Decision Making Study of Oncotype DX® Breast Cancer Test Among Spanish Physicians

Results, Presented at European Society for Medical Oncology (ESMO) Congress, Demonstrate More Than 30% Change in Treatment Recommendations in Spain Consistent With United States

REDWOOD CITY, CA--(Marketwire - October 11, 2010) - Genomic Health, Inc. (NASDAQ: GHDX) today announced positive results from a prospective, multi-center, study that showed the Oncotype DX® Recurrence Score® (RS) result had a significant impact on treatment decisions for early-stage breast cancer patients in Spain. The study found that knowledge of a patient's RS changed oncologists' treatment recommendations in 31.8 percent of cases, which is similar to what has been shown in U.S. studies evaluating the impact of the RS on treatment decisions. These findings were presented Saturday, October 9th during a poster discussion session at the 2010 European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

The Oncotype DX breast cancer test measures the expression of 21 genes of an individual breast cancer tumor to generate a RS that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage patients. As of June 30, 2010, more than 10,000 physicians in more than 55 countries had ordered more than 160,000 Oncotype DX tests. The test was launched in the United States in 2004 where it has been widely adopted for guiding treatment decisions in early-stage breast cancer. Genomic Health has an exclusive agreement with Palex Medical S.A., one of Europe's leading distributors of medical device and diagnostic services to hospitals, to distribute the test in Spain and Portugal. 

"In this study involving physicians from Spain's leading breast cancer research organization, we've found that the Oncotype DX Recurrence Score does influence treatment recommendations and increases confidence in those decisions similar to what has been experienced in the United States," said Joan Albanell, MD, Director of the Medical Oncology Service at the Hospital del Mar, Barcelona. "These results support the clinical utility for Oncotype DX in Spanish patients with early-stage breast cancer."

This study evaluated 107 cases from seven GEICAM (Spanish Group of Breast Cancer Research) sites to prospectively examine whether RS affects medical oncologists adjuvant treatment selection. Treatment recommendations changed for 32 percent of patients: 21 percent switching from an initial pre-RS plan of chemotherapy plus hormonal therapy to a treatment plan of hormone therapy alone and 11 percent switching from an initial pre-RS plan of hormone therapy to a treatment plan of chemotherapy plus hormone therapy. Researchers also assessed physicians' experience in using the Oncotype DX breast cancer test and the impact it had on their confidence levels about breast cancer treatment decisions. The study found that in 61 percent of the cases, oncologists reported increased confidence in their treatment decision, and decreased confidence in only 7% of cases.

"We are proud to partner with Genomic Health in delivering the Oncotype DX breast cancer test to patients in Spain and Portugal and believe these new data support additional adoption in this region of the world," said Dr. Xavier Carbonell, CEO of Palex Medical S.A. 

"As international use of the Oncotype DX breast cancer test increases, it is essential to evaluate how the determination of high Recurrence Score disease and low Recurrence Score disease impacts physician recommendations and patient experiences throughout the world," said Steven Shak, M.D., chief medical officer of Genomic Health. "This study marks the first among a European population and the seventh in total to have been presented or published, demonstrating the Recurrence Score's ability to identify many patients who can be spared chemotherapy as well as those who are likely to experience large benefit from chemotherapy that outweigh the risks."

In a separate presentation on Sunday, October 10th, researchers presented collective findings from five studies of more than 3,000 patients that were used to develop and validate the Oncotype DX® 12 gene colon cancer Recurrence Score® as an independent predictor of recurrence in stage II colon cancer that provides value beyond other available measures.

"These findings, previously presented at various American Society of Clinical Oncology meetings and recently published in the Journal of Clinical Oncology, served as the basis for the landmark QUASAR validation study, which demonstrated that the Oncotype DX colon cancer test can independently predict individual recurrence risk in stage II colon cancer patients following surgery," said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford. "This test is now being used by physicians worldwide, and represents an important advancement in bringing personalized medicine to the tens of thousands of people who suffer from stage II colon cancer, as the availability of precise markers to determine likelihood of recurrence risk is limited in today's clinical setting."

About Oncotype DX® Breast Cancer Test
The Oncotype DX breast cancer test is the first and only multigene expression test to be included in the published guidelines of both the American Society of Clinical Oncology and the National Comprehensive Cancer Network, to predict the likelihood of chemotherapy benefit as well as recurrence, for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. Additionally, physicians use Oncotype DX to make treatment recommendations for certain node-positive breast cancer patients, and the test report also provides quantitative scores for select individual genes. Oncotype DX 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. 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. For more information about Oncotype DX for breast cancer, please visit www.oncotypedx.com.

About Oncotype DX® Colon Cancer Test
The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk of recurrence in patients with stage II colon cancer. For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company's Oncotype DX breast cancer test. National Surgical Adjuvant Breast and Bowel Project (NSABP) conducted three development studies and Cleveland Clinic conducted one development study, all of which were funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. The final set of seven recurrence and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study. For more information about Oncotype DX for colon cancer, please visit www.oncotypedx.com

About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a life science company focused on the global 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. As of June 30, 2010, more than 10,000 physicians in over 55 countries had ordered more than 160,000 Oncotype DX tests. 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 belief the Oncotype DX breast cancer test provides a significant clinical benefit in treatment planning for early-stage breast cancer patients in Spain or other countries and the belief that the study supports the company's efforts to expand use of Oncotype DX into breast cancer treatment planning in Spain. 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 we may not be able to expand use of Oncotype DX Spain or internationally; our ability to obtain or maintain sufficient levels of reimbursement for our tests; the risks and uncertainties associated with the regulation of our 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 September 30, 2010. 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 and Oncotype DX are trademarks or registered trademarks of Genomic Health, Inc.

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