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Genomic Health Announces Results of Initial Studies to Develop Predictive Tests for Targeted Therapies

- Results from Gene Identification Studies Presented at ASCO Support Further Exploration of Possible Tests to Predict Response to Targeted

Therapies for Colon and Breast Cancers -

REDWOOD CITY, Calif., May 31 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX), provider of the Oncotype DX(R) breast cancer assay, today announced results of two separate studies presented at the annual meeting of the American Society of Clinical Oncology (ASCO), that could lead to the development of new tests for predicting benefit from certain targeted therapies in cancer, specifically cetuximab (ERBITUX(R)) for colon cancer and docetaxel (Taxotere(R)) for breast cancer. Oncotype DX is the first and only genomic test that predicts the likelihood of chemotherapy benefit as well as likelihood of disease recurrence for early-stage breast cancer patients.

"These new data represent encouraging results of our work with leading cancer cooperative groups and drug manufacturers to discover and develop genomic tests to determine which patients are likely to benefit from treatment with targeted therapies," said Steven Shak, M.D., chief medical officer of Genomic Health. "We believe this is an important step forward in demonstrating the potential of a diagnostic and therapeutic partnership in advancing the field of personalized medicine."

The first study, "Evaluation of tumor gene expression and K-Ras mutations in formalin-fixed, paraffin-embedded tumor tissue as predictors of response to cetuximab in metastatic colorectal cancer," (abstract 3512) represents the first publicly presented results of Genomic Health's collaboration with Bristol-Myers Squibb and ImClone Systems Incorporated for ERBITUX (cetuximab), a targeted therapy for colon cancer.

Researchers analyzed formalin-fixed, paraffin-embedded tumor samples from 226 colon cancer patients from three studies of ERBITUX. The samples were examined for K-Ras gene mutations, which are commonly observed in colon cancer, and for the expression of 102 previously identified candidate genes that may be associated with disease control and progression-free survival in patients treated with ERBITUX.

Of the 226 analyzed samples, 36 percent (82 patients) had K-Ras mutations and a significantly lower disease control rate (23 percent) compared to those who did not exhibit the gene mutation (60 percent). Among all 226 samples, quantitative expression of 40 genes was significantly associated with disease control. Together, the results suggest that quantitative expression of a number of the candidate genes used in conjunction with K-Ras mutation status increases the ability to predict which patients might benefit from treatment with ERBITUX over K-Ras status alone.

"Based on these results, we believe there is a potential to develop a multi-gene test comprising K-Ras mutation status in combination with the expression levels of a small number of genes to select patients for cetuximab," said Joffre Baker, Ph.D., chief scientific officer of Genomic Health and lead author of the study.

The research for the second study, "Predictive utility of progesterone receptor and multigene expression in identifying benefit from adjuvant doxorubicin plus cyclophosphamide or docetaxel in intergroup trial E2197," (abstract 557) was led by the Eastern Cooperative Oncology Group (ECOG). Researchers evaluated the predictive utility of progesterone receptor (PR) protein expression by IHC in a central lab and quantitative RNA expression by RT-PCR for 371 genes, including the current Oncotype DX 21-gene panel, for treatment either with doxorubicin plus cyclophosphamide (AC), or with doxorubicin plus docetaxel (AT). The study used samples from 734 patients who received at least three to four treatment cycles.

Results showed that in patients with hormone receptor positive disease who had an Oncotype DX Recurrence Score(TM) result greater than 18 (i.e., who were classified as intermediate risk of recurrence or above), a number of candidate genes strongly predicted benefit from treatment with docetaxel (Taxotere), a type of taxane commonly used for breast cancer therapy. A genomic classifier predicting differential benefit was identified and, if validated through additional studies, might be useful in defining differential benefit of docetaxel.

"We continue to gain meaningful insight into the biology of breast cancer and now, possibly, treatment benefit for a common taxane regimen with our ongoing study of the utility of Oncotype DX and additional breast cancer genes," said Lori J. Goldstein, M.D., Director of the Breast Evaluation Center at Fox Chase Cancer Center in Philadelphia, Pennsylvania, and lead author of the study. "Further research to narrow down which genes are most predictive and validate their use could potentially yield a new panel of genes that may predict the benefit of treatment with docetaxel."

About Oncotype DX(R)

Oncotype DX 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. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 3,600 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. To date, 7,500 physicians have ordered more than 55,000 tests, and health plans covering over 80 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and 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. For more information about Oncotype DX, please visit

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 chemotherapy benefit as well as recurrence in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit

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 the results of these studies could lead to the development of new tests for predicting the benefit of certain targeted therapies used in the treatment of cancer. These risks and uncertainties include, but are not limited to: the results of additional clinical studies; the risk that we may not obtain sufficient levels of reimbursement for any future tests we may develop; our ability to develop and commercialize new products; the risks and uncertainties associated with the regulation of our tests by FDA; our ability to obtain capital when needed; our history of operating losses 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 three-month period ended March 31, 2008. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: 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.

SOURCE Genomic Health, Inc.
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