Genomic Health Announces Study Confirming Prognostic Value Of Oncotype DX(R) Recurrence Score(R) Result In Japanese Breast Cancer Patients

Main Category: Breast Cancer
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 21 Apr 2009 - 1:00 PDT

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Genomic Health, Inc. (Nasdaq: GHDX) announced results of a multi-center Japanese study demonstrating that the Oncotype DX breast cancer assay had significant prognostic value in Japanese women with estrogen receptor-positive early-stage breast cancer. Oncotype DX identified a large portion of patients in Japan who had estrogen receptor-positive early-stage breast cancer as having a low likelihood of distant recurrence. Researchers from the Japan Breast Cancer Research Group presented results in an oral presentation at the 2009 Kyoto Breast Cancer Consensus Conference International Convention in Kyoto, Japan on April 17.

Oncotype DX has been available in Japan since 2007 via SRL, Inc., the exclusive distributor of Oncotype DX in Japan.

"These results highlight the clinical utility of this assay for treatment planning for early-stage breast cancer across populations, including patients in Japan with breast cancer," said Masakazu Toi, M.D., Ph.D., Professor of the Department of Surgery at Kyoto University School of Medicine and a director of the Japan Breast Cancer Research Group. "Based on these results, we believe that Oncotype DX should be integrated into standard breast cancer treatment planning for patients in Japan."

Researchers evaluated tumor samples from 200 patients with early-stage, estrogen receptor-positive, lymph node negative breast cancer, who were treated with tamoxifen, and who had surgery between 1992 and 1998. The Oncotype DX breast cancer assay was performed on all individual tumor specimens and the continuous Recurrence Score(R) was strongly associated with the risk of distant recurrence (p<0.001). In addition, these patients were categorized into Recurrence Score groups based on the standard cutoff points of 18 and 31; 48 percent had a Recurrence Score less than 18, 20 percent had a Recurrence Score between 18 and 30, and 33 percent had a Recurrence Score greater than or equal to 31. The distribution of Recurrence Scores in the Japanese population was similar to that found in previous multicenter studies performed in the United States. Finally, as shown consistently across multiple Oncotype DX studies, the risk of distant recurrence in the group with a Recurrence Score less than 18 (3% at 10 years) was shown to be significantly lower than the group with a Recurrence Score greater than or equal to 31 (25% at 10 years) (p<0.001). A large proportion of breast cancer patients in Japan were identified by the Recurrence Score to have a low likelihood of distant recurrence when treated with tamoxifen alone without chemotherapy.

About Oncotype DX(R)

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 eleven 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 December 31, 2008, 7,500 physicians have ordered more than 85,000 tests, and both Medicare and private health plans covering approximately 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 (ASCO) 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.

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(R), which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in a large portion of early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California.

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 belief that Oncotype DX should be integrated into standard breast cancer treatment planning for patients in Japan. 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 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 Annual Report on Form 10-K for the year ended December 31, 2008. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

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.

Source: Genomic Health

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