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The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health Announce Study Results Demonstrating Precision of Oncotype DX(TM) in Measuring Estrogen Receptor Status

Posted on: Friday, 15 December 2006, 18:00 CST

SAN ANTONIO, Dec. 15 /PRNewswire-FirstCall/ -- The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. today announced positive results of a new study that compared measurement of estrogen receptor (ER) expression by three methods, including quantitative ER expression as measured by the Oncotype DX breast cancer assay. This study, presented at the 29th Annual San Antonio Breast Cancer Symposium, demonstrates that Oncotype DX's quantitative measurement of ER expression has the strongest correlation to distant recurrence, or length of time following treatment before a cancer returns, of the three tested methods.

"The assessment of ER expression is a crucial factor that influences treatment for women with breast cancer, yet the power of different testing methods varies considerably," stated Norman Wolmark, M.D., chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), and the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania. "Results from this study suggest Oncotype DX may be the most precise way to measure this widely used biomarker, and could possibly expand how we use the Oncotype DX assay in the future."

Researchers measured ER expression using three different methods in 297 patients with node-negative, ER-positive breast cancer who were treated with tamoxifen in a previously conducted NSABP B-14 study. Ligand binding (LB) for ER was performed by the study sites at the time patients were enrolled. The NSABP Foundation Laboratory used DakoCytomation ER/PR pharmDx to measure ER with immunohistochemistry. Finally, ER was measured as one of the 21 genes in the Oncotype DX breast cancer assay, which uses quantitative RT-PCR.

For all three methods, as expected, higher ER expression in this group of estrogen receptor-positive patients treated with tamoxifen was associated with longer time to distant recurrence. The quantitative RT-PCR measure of ER expression determined by Oncotype DX had the strongest association with time to recurrence. In addition, tests to measure the relationship between these ER measurements and time to recurrence yield p-values: p<0.0001 (RT-PCR), p=0.003 (IHC), and p=0.045 (ligand binding), respectively.

"We are encouraged by these initial results and are performing additional studies of single gene reporting with Oncotype DX in the hopes of further expanding the clinical utility of the test to help physicians and individual patients estimate the magnitude of benefit they may expect from other treatments, such as tamoxifen," said Steven Shak, M.D., chief medical officer of Genomic Health.

This study is the first of five to be presented at the San Antonio Breast Cancer Symposium providing additional insight on Oncotype DX, the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. Additional research is scheduled to be presented as follows:

-- Subtypes of breast cancer defined by standardized quantitative RT-PCR analysis of 10,618 tumors (Abstract 6118) Sunday, December 17 - 7:00 a.m. -- Relationship between proliferation genes and expression of hormone and growth factor receptors: quantitative RT-PCR in 10,618 breast cancers (Abstract 6111) Sunday, December 17 - 7:00 a.m. -- The impact on the Recurrence Score due to patient variation in the quantitative expression of individual genes or gene groups (Abstract 6039) Sunday, December 17 - 7:00 a.m. -- Quantitative RT-PCR analysis of ER and PR by Oncotype DX indicates distinct and different associations with prognosis and prediction of tamoxifen benefit (Abstract 45, oral presentation) Sunday, December 17 - 10:30 a.m. About NSABP

The NSABP, headquartered in Pittsburgh, PA, is a not-for-profit, clinical trials cooperative group, which includes a network of 10,000 professionals located in the U.S., Canada, Puerto Rico, Ireland and Australia. Research conducted by the NSABP is supported primarily by grants from the National Cancer Institute. For almost 50 years, the NSABP has successfully conducted large-scale, randomized clinical trials in colorectal and breast cancer that have altered and improved the standard of care for men and women with these diseases. To learn more about the NSABP, please visit http://foundation.nsabp.org/ .

About Oncotype DX

Oncotype DX represents the first diagnostic multi-gene expression test service commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. 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. For more information about Oncotype DX, please visit http://www.oncotypedx.com/ .

About Genomic Health

Genomic Health, Inc. 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 service, Oncotype DX(TM), which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in 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/ .

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the preciseness of Oncotype DX and possible future uses for the test, Genomic Health's expectations regarding additional studies and expansion of the clinical utility of Oncotype DX, its potential effect on clinical practice and treatment decisions for patients and the applicability of clinical study results to actual outcomes. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include the risks set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, which is on file with the Securities and Exchange Commission and is available on the SEC's website at http://www.sec.gov/ . These forward-looking statements speak only as of the date hereof. We disclaim any obligation to update these forward- looking statements.

Genomic Health, Inc.

CONTACT: Media, Emily Faucette, +1-415-946-1066, ormedia@genomichealth.com, or Investors, Brad Cole, +1-650-569-2281, orinvestors@genomichealth.com; or Holly McCalmon of NSABP, +1-412-330-4616, orholly.mccalmon@nsabp.org

Web site: http://www.genomichealth.com/http://www.oncotypedx.com/http://foundation.nsabp.org/

Source: PRNewswire-FirstCall

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