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Genomic Health Announces Data Confirming Manual Microdissection of Biopsy Cavities Is Essential for Accurate Recurrence Risk Assessment in Early-Stage Breast Cancer Patients
Date:10/9/2009

SAN FRANCISCO, Oct. 9 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a study demonstrating the critical role of manual microdissection to remove all biopsy cavities from breast cancer specimens. Genomic Health's Oncotype DX is the only commercially available breast cancer test that employs manual microdissection following review by a board certified surgical pathologist with breast expertise to predict a patient's benefit from chemotherapy and risk of disease recurrence. This study was discussed in a poster presentation at the ASCO 2009 Breast Cancer Symposium in San Francisco.

Oncotype DX measures the expression of 21 genes of an individual tumor removed during surgery to generate a Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients. The Oncotype DX assay is performed on tumor tissue removed either by core biopsy, a commonly used diagnostic procedure for the initial diagnosis of breast cancer, or by surgery, lumpectomy or mastectomy. Since many tumor specimens removed by lumpectomy or mastectomy contain biopsy cavities researchers conducted this study to determine whether the presence of these cavities impacts gene expression and recurrence risk assessment.

"This analysis confirms that the inclusion of biopsy cavities in breast cancer specimens is associated with significant changes in the expression of individual genes, and can ultimately drive the Recurrence Score result higher," said Theodore Miller, MD, professor of pathology at the University of California San Francisco Medical Center. "The removal of biopsy cavities by manual microdissection is warranted by the study's findings and should be practiced as part of any molecular breast cancer diagnostic platform that assesses risk of recurrence by examination of tumor tissue."

The study assessed 53 invasive breast carcinomas (19 well-, 19 moderately-, and 15 poorly-differentiated) to determine differences in gene expression between whole sections that contained biopsy cavities, enriched tumors where biopsy cavities were excluded and the dissected biopsy cavities. Standardized quantitative reverse transcription polymerase chain reaction (RT-PCR) analysis for the 21 genes was performed.

The results indicated that there was a statistically significant average increase in the Recurrence Score result for whole sections versus enriched tumors (5.35 Recurrence Score Units; p < .0001). There were also statistically significant differences in reference normalized gene expression between enriched tumor and whole sections in 12 of the 16 cancer-related genes. Additionally, biopsy cavities tended to have high-risk Recurrence Scores.

"Careful histologic review of each patient case by a board-certified surgical pathologist and manual microdissection to remove all biopsy cavities when necessary has been standard practice in our lab since the Oncotype DX test became available in 2004," said Rick Baehner, MD, director of pathology at Genomic Health and assistant professor of clinical pathology at the University of California San Francisco Medical Center. "This study underscores the critical role that expert pathologists play in working with the clinical laboratory to provide the most accurate molecular assessment of individual tumors so that physicians and patients can make well-informed individual treatment decisions."

Also presented at this week's Breast Cancer Symposium were results of a multi-center Japanese study demonstrating that the Oncotype DX breast cancer test had significant prognostic value in Japanese women with estrogen receptor-positive early-stage breast cancer. In this study that was originally presented at the 2009 Kyoto Breast Cancer Consensus Conference International Convention, 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.

About Oncotype DX®

The Oncotype DX breast cancer test is the only multigene 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 test has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer breast cancer patients worldwide, 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 May 2009, more than 8,000 physicians have ordered more than 100,000 tests in over 40 countries, and both Medicare and private health plans covering over 90 percent of U.S. insured lives, provide reimbursement for Oncotype DX through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology 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 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 the Oncotype DX breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health is preparing to launch its Oncotype DX colon cancer test in early 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit 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 applicability of clinical study results to actual outcomes, the belief that manual microdissection should be practiced as a part of any molecular breast cancer diagnostic platform that assesses risk of recurrence by examination of tumor tissue, the belief that expert pathologists play a critical role in working with the clinical reference laboratory to provide the most accurate molecular assessment of individual tumors so that physicians and patients can make well-informed individual treatment decisions, and the company's plans to commercialize a test for colon cancer and the proposed timing of such commercialization. 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; the risks and potential delays associated with commercialization of a new test; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: 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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SOURCE Genomic Health, Inc.
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