Genomic Health Announces Preliminary Results From A Study Of Oncotype DX(TM) In Node-Positive Breast Cancer Patients

Main Category: Breast Cancer
Also Included In: Endocrinology;  Women's Health / Gynecology;  Clinical Trials / Drug Trials
Article Date: 12 Oct 2007 - 0:00 PDT

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Genomic Health, Inc. (Nasdaq: GHDX) announced encouraging results from a study of Oncotype DX in postmenopausal women with node-positive, hormone receptor positive breast cancer conducted by the Southwest Oncology Group (SWOG), a National Cancer Institute clinical trials cooperative group. Oncotype DX is a multi-gene expression test that physicians currently use to predict the likelihood of recurrence and the likelihood of chemotherapy benefit for women with estrogen receptor positive, node-negative breast cancer. This study focused on a different population of patients and results suggest the Oncotype DX test may be useful in predicting survival without recurrence and the benefit of chemotherapy for node-positive breast cancer patients.

For this study, researchers analyzed tumor samples from patients in the SWOG/ Breast Cancer Intergroup of North America trial that evaluated postmenopausal patients with node-positive, hormone receptor positive breast cancer who were treated with chemohormonal therapy (cyclophosphamide, doxorubicin, 5-fluorouracil, followed by tamoxifen) versus tamoxifen alone. Benefit of the addition of chemotherapy was observed in patients with high Oncotype DX Recurrence Scores. However, chemotherapy did not appear to benefit patients with low Oncotype DX Recurrence Scores, despite the presence of positive nodes. These results may be clinically useful in some patients with hormone receptor positive, node-positive breast cancer.

SWOG and Genomic Health plan to submit these data for presentation at the 30th Annual San Antonio Breast Cancer Symposium, December 12 - 16.

About Oncotype DX(TM)

Oncotype DX is the first multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of breast cancer survival and the likelihood of chemotherapy benefit in women with estrogen receptor-positive, node-negative, tamoxifen-treated breast cancer. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 2,600 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 June 30, 2007, over 6,000 physicians have ordered a cumulative total of more than 33,000 tests and the test is now covered by reimbursement contracts and agreements with health plans covering approximately 145 million lives. For more information about Oncotype DX, please visit http://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 its first test, Oncotype DX(TM), 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. For more information, please visit http://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 findings suggesting that Oncotype DX predicts disease-free survival and the benefit of chemotherapy in some node-positive patients, the potential clinical utility of our test in some node-positive patients, and our plans to submit the data from this study at the 2007 San Antonio Breast Cancer Symposium. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: the applicability of clinical results to actual outcomes; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risks and uncertainties associated with the regulation of our test by FDA; our ability to obtain capital when needed; our history of operating losses; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

Genomic Health, 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.

Genomic Health, Inc.
http://www.genomichealth.com

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