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Genomic Health's Oncotype DX(R) Colon Cancer Test Predicts Individualized Recurrence Risk for Stage II Colon Cancer Patients
Date:5/14/2009

-Positive Results from Landmark Validation Trial Highlighted Today at American Society of Clinical Oncology (ASCO) Presscast-

-Genomic Health Plans to Launch Oncotype DX Colon Cancer Test in Early 2010-

REDWOOD CITY, Calif., May 14 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from the landmark QUASAR validation study, which demonstrated that the Oncotype DX(R) colon cancer test can independently predict individual recurrence risk in stage II colon cancer patients following surgery. Importantly, the Oncotype DX colon cancer Recurrence Score(R) provided additional independent clinical value beyond standard measures. The study showed that the colon cancer Recurrence Score maintained significance (p=0.008), independent of mismatch repair (MMR), also known as MSI (Microsatellite Instability), T-stage, nodes examined, grade and lymphovascular invasion.

These findings, which were selected from more than 4,000 accepted abstracts to be featured in the American Society of Clinical Oncology's (ASCO) advance presscast earlier today, address a large unmet need in the treatment of colon cancer by validating a clinical tool that can significantly improve risk assessment in the treatment planning for stage II colon cancer patients. Genomic Health announced these data in conjunction with ASCO's advance presscast presentation and subsequent embargo lift of all accepted abstracts today, and looks forward to the full data presentation at ASCO's annual meeting in Orlando, Florida on Saturday, May 30 at 3 p.m. ET.

"These clinical results represent an important advancement in bringing personalized medicine to the tens of thousands of people who suffer from stage II colon cancer, as the availability of precise markers to determine likelihood of recurrence risk are limited in today's clinical setting," said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford. "With these results we have a validated multi-gene test to predict colon cancer recurrence that, when available, will enable physicians to better select patients for aggressive treatment beyond surgery."

David Kerr, Richard Gray, Ph.D., professor of medical statistics at the University of Birmingham, and Philip Quirke, B.M., M.D. FRCPath, professor of pathology and tumor biology at the University of Leeds, are the principal investigators of the QUASAR validation study.

A second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater proportional benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery was not met (p=0.19).

"The positive findings from the QUASAR validation study strongly support a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of three measures, Recurrence Score, MMR/MSI and T-stage," said Steve Shak, M.D., chief medical officer of Genomic Health. "We believe the Oncotype DX colon cancer Recurrence Score will provide the greatest clinical utility for treatment selection in the more than 70 percent of patients for whom MMR/MSI and T-stage are uninformative."

The Oncotype DX colon cancer Recurrence Score maintained its independent significance in predicting the likelihood of recurrence risk (p=0.008), when analyzed in the presence of all the other factors. T4 stage (p=0.005) and MMR deficiency (p<0.001) were also independently beneficial in predicting recurrence, and together comprise approximately 25 percent of patients. T4 stage indicates growth of the tumor through the wall of the bowel and is associated with higher risk of recurrence. MMR/MSI is an alteration observed in approximately 15 percent of colon cancers. Patients with tumors identified as MSI high, or MMR deficient, are considered to be at low risk of recurrence.

With this result, QUASAR represents the largest study to confirm the importance of MMR/MSI in stage II colon cancer. MMR/MSI testing, although not routinely performed, is currently provided by many pathology laboratories. Genomic Health is evaluating its role in advancing the incorporation of MMR/MSI testing in colon cancer treatment planning.

The Oncotype DX colon cancer Recurrence Score is calculated from the quantitated expression of 7 recurrence genes and 5 reference genes in the tumor tissue and is expressed as an individual score ranging from 0 to 100. In the QUASAR validation study, the recurrence risk increased with increasing Recurrence Scores, with an average recurrence risk at three years of 12 percent, 18 percent and 22 percent in the pre-defined low, intermediate and high recurrence risk groups, respectively. The study further defined a continuous individualized recurrence risk at three years ranging from a low risk of 9 percent-11 percent to a high risk of 25 percent-27 percent.

Based on the positive QUASAR results, Genomic Health is proceeding with commercialization plans and expects to make the 12-gene Oncotype DX colon cancer test available to physicians and patients in early 2010. The company currently markets the widely-adopted Oncotype DX breast cancer test, clinically validated to predict the likelihood of recurrence and chemotherapy benefit in early-stage breast cancer.

More than 150,000 people worldwide are diagnosed with stage II colon cancer (also known as Dukes' Stage B) each year, including 30,000 to 40,000 in the United States alone, and the current treatment paradigm is unclear. The decision to treat patients with chemotherapy following surgery is based on an assessment of how likely their disease is to recur. However, accurately identifying those patients with high recurrence risk is a critical issue for physicians because the available markers to determine likelihood of disease recurrence are limited, resulting in both over-treatment and under-treatment of patients following surgery.

"Patients with stage II colon cancer are often faced with tough decisions about treatment," said Carlea Bauman, President of C3: Colorectal Cancer Coalition. "These findings will help patients and their physicians make decisions based on each patient's potential risk. This is critically important to patients facing treatment options that can be life-altering. Patients want the assurance that they are receiving the most appropriate course of treatment for their individual disease."

Developmental Work Conducted by National Surgical Adjuvant Breast and Bowel Project (NSABP) and Cleveland Clinic

For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company's Oncotype DX breast cancer test. The NSABP conducted three development studies and Cleveland Clinic conducted one development study, which was funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. Detailed analysis of gene expression and colon cancer recurrence was performed to identify specific genes with the potential to predict the likelihood of cancer recurrence and response to chemotherapy. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI.

The final set of seven recurrence, six treatment and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study. This international, multi-center randomized trial examined the benefit associated with adjuvant 5FU/LV. The majority of samples for this analysis of the Oncotype DX colon cancer test are from the United Kingdom. Gene expression was quantified by RT-PCR from manually microdissected fixed paraffin-embedded primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed using Cox regression.

The Quasar study abstract and data presented during ASCO's presscast are available at www.asco.org.

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, the Oncotype DX breast cancer test, 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 applicability of clinical study results to actual outcomes; the company's plans to commercialize a test for colon cancer and the proposed timing of such commercialization; the company's beliefs regarding the benefits of a test for colon cancer and the belief that Oncotype DX should be integrated into standard breast cancer treatment planning for patients in Japan. 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 risks associated with commercialization of a new test; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the risks and uncertainties associated with the regulation of its tests; the applicability of clinical study results to actual outcomes; 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 March 31, 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.


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