Multiple Studies Presented at the American Society of Clinical Oncology Meeting Show Consistent Positive Results for the Oncotype DX™ Breast Cancer Assay

-- Data Presentations Reinforce Recurrence Score's Ability to Predict Chemotherapy Benefit; Capture Prognosis and Response to Tamoxifen

-- ASCO selects National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health chemotherapy response study for "Best of Oncology" special session

ORLANDO - May 17, 2005 - Genomic Health, Inc. announced that results from three independent studies evaluating the Oncotype DX breast cancer assay were presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO). These studies examined the assay's ability to quantify likelihood of recurrence, predict response to chemotherapy, and capture both prognosis and response to tamoxifen in a large portion of early stage breast cancer patients. Initial findings from these studies were presented at the 27th Annual San Antonio Breast Cancer Symposium (SABCS) in December 2004.

"The fact that these studies continue to gain attention among the oncology community is a significant indication of the impact Oncotype DX is having in clinical practice," said Steven Shak, M.D., chief medical officer, Genomic Health. "Genomic Health and its collaborators, including NSABP and Kaiser Permanente, are leading the field of individualized medicine by bringing Oncotype DX into oncology practice today."

ASCO's "Best of Oncology" Features NSABP's B-20 Chemotherapy Response Study

The NSABP/Genomic Health study "Expression of the 21 genes in the Recurrence Score assay and prediction of clinical benefit from tamoxifen in NSABP study B-14 and chemotherapy in NSABP study B-20" was selected from numerous studies by the ASCO Cancer Education Committee to be featured in a special session called "Best of Oncology." The study -- which demonstrated the same Oncotype DX 21-gene panel that quantifies the likelihood of breast cancer recurrence also predicts chemotherapy benefit -- will be presented by Soonmyung Paik, M.D., director of the NSABP Division of Pathology, on Tuesday, May 17, 2005, 12:00-12:10pm (EDT) during a session where ASCO highlights critical scientific advances in oncology that have been presented at other oncology-related meetings in the last year. The NSABP/Genomic Health Study is the only study from the 2004 San Antonio Breast Cancer Symposium to be selected as "Best of Oncology."

The NSABP B-20 chemotherapy benefit study of 651 patients demonstrated that breast cancer patients with high Recurrence Scores (and high risk of recurrence), as identified by the Oncotype DX assay, also have a large absolute benefit from chemotherapy. This group represents about 25 percent of patients with node-negative, estrogen receptor-positive breast cancer. Patients with low Recurrence Scores (and low risk of recurrence) only derive minimal, if any, benefit from chemotherapy and represent about 50 percent of patients with node-negative, estrogen receptor-positive breast cancer.

"These findings are changing the way breast cancer treatment decisions are made today," said Norman Wolmark, M.D., chair of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania. "We now have a tool that allows physicians and patients to feel confident about their choice of therapy based on a Recurrence Score that reflects their individual disease."

NSABP B-14 Tamoxifen Benefit Study

On Sunday, May 15, Genomic Health and NSABP presented results from a study (Abstract #510) that evaluated tumor tissues from 645 patients in the NSABP B-14 trial, who were treated either with placebo or with tamoxifen, to determine whether the Oncotype DX Recurrence Score assay reflects pure prognosis, responsiveness to hormonal therapy, or both. Results of the study presented in an oral discussion showed that the assay predicts the likelihood of recurrence in node-negative, estrogen receptor-positive breast cancer because it captures both prognosis and the response to hormonal treatment.

"In combining both prognostic and predictive factors for patients with node-negative estrogen receptor-positive breast cancer, Oncotype DX can help us determine which patients will benefit from hormonal treatment," said Soonmyung Paik, M.D., director of the NSABP Division of Pathology. "These findings reinforce the important insight we gain from the Recurrence Score and its significant contribution to the individualized treatment of patients diagnosed with breast cancer."

Northern California Kaiser Permanente Study

Northern California Kaiser Permanente presented findings on Monday, May 16, from a community-based study from 14 Northern California hospitals (Abstract #603, Poster # C12). These results of the study of 790 cases and controls showed a strong and graded association between the Oncotype DX Recurrence Score and 10-year breast cancer-specific mortality (p<0.001). The assay provided information that goes beyond that provided by tumor size and tumor grade. The Oncotype DX assay identifies a large proportion of these women who have a low risk (less than 3 percent) of breast cancer death at 10 years. These results in a community-based patient population representing approximately one percent of the U.S. population were similar to those from the large trials conducted previously by the NSABP, including the one published in The New England Journal of Medicine in December 2004.

This study also looked at node negative patients with ER positive or ER negative tumors who were not treated with tamoxifen and found that the Oncotype DX assay and the Quantitative Proliferation Index - a subset of genes from the assay - predicted risk of recurrence in this patient population. The results from this part of the study closely paralleled those from the B-14 Tamoxifen Benefit study noted above.

American Journal of Managed Care Publishes Economic Analysis

On Friday, May 13, the American Journal of Managed Care published a comprehensive economic analysis that demonstrated Oncotype DX, when used appropriately, can reduce treatment costs and simultaneously improve net medical outcomes, including survival, when adjusted for the negative impact on quality of life associated with chemotherapy treatment.

About Oncotype DX

Introduced in 2004, the Oncotype DX breast cancer assay represents the first diagnostic gene expression test on the market that provides consistent results across multiple independent trials. The assay has been extensively evaluated in numerous independent studies involving more than 2,600 breast cancer patients, including a large validation study published in the December 30, 2004 edition of The New England Journal of Medicine. For more information about Oncotype DX, please visit www.oncotypedx.com.

About Genomic Health

Genomic Health, Inc. is an oncology-based biotechnology company that provides clinically validated genomic tests to improve the quality of treatment decisions for patients with cancer. The company employs a sophisticated, quantitative approach to molecular pathology (the Oncotype DX platform) to provide to cancer patients and their physicians individualized genomic information on the likelihood of disease recurrence and response to therapy. The company was founded in August 2000 and provides commercial Oncotype DX services through its CLIA and CAP certified clinical reference laboratory located at its headquarters in Redwood City, California.

Contacts:
Emily Faucette: 415/595-9407
Lori Garvey/NSABP: 412/330-4621

Contact Information

For Investors:
650.569.2281
investors@genomichealth.com

For Media:
650.569.2215
media@genomichealth.com

  

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