Healthcare Industry News:  Oncotype DX 

Oncology Diagnostics

 News Release - June 4, 2006

The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. Announce Positive Early Results in Development of Genomic Test for Colon Cancer Prognosis

Results from gene identification study presented at ASCO demonstrate correlation between gene expression and colon cancer recurrence

Findings strongly support additional studies and development of Oncotype test service for colon cancer


ATLANTA, June 4 (HSMN NewsFeed) -- The Pittsburgh-based National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. (Nasdaq: GHDX ) today announced positive results of a new study that identified genes associated with prognosis in patients with stage II and III colon cancer treated with surgery. Results from this study (Abstract #3518), which used the same RT-PCR technology Genomic Health applies in its Oncotype DX breast cancer test service, were presented today at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).

Researchers analyzed RNA from 270 colon cancers among patients enrolled in studies previously conducted by the NSABP between 1977 and 1984, including 128 patients with stage II disease and 142 patients with stage III disease. Of the 757 cancer-related and reference genes assessed, 142 genes exhibited an association with recurrence-free interval, or a period of time when the disease has not returned (nominal p-value <0.05). After controlling for routinely assessed clinical variables, 78 of these genes retained independent significance (p<0.05).

"We have shown, using a standardized quantitative technique, that tumor gene expression at the time of diagnosis is clearly associated with the likelihood of subsequent recurrence in colon cancer patients," said Michael O'Connell, M.D., associate chairman of the NSABP, and director of the Allegheny General Hospital Cancer Center in Pittsburgh, PA. "Additional studies are under way to determine whether gene expression analysis can also predict response to adjuvant chemotherapy which, in combination with prognostic information, would enable us to make more individualized treatment decisions for colon cancer patients."

Current diagnostic methods may limit clinicians' ability to assess prognosis for patients with colon cancer who undergo surgery, making it difficult to determine who would benefit most from adjuvant chemotherapy. This lack of clarity may lead to the over-treatment of some patients and the under-treatment of others. Researchers conducting this study believe a validated assay that could quantify the risk in such patients could help better individualize therapy.

"This early data is very encouraging. We have also completed a second study of stage II and III colon cancer patients which confirmed the prognostic significance of many of the genes identified here," said Steven Shak, M.D., chief medical officer of Genomic Health. "Moving forward, we expect to follow a rigorous clinical development path, as we did with our Oncotype DX test service in breast cancer, conducting multiple studies to develop a reliable test service for predicting recurrence and response to chemotherapy in colon cancer."

About NSABP

The NSABP, headquartered in Pittsburgh, PA, is a not-for-profit, clinical trials cooperative group, which includes a network of 3,000 professionals located in the U.S., Canada, Europe and Puerto Rico. 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 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 service, Oncotype DX, which has been shown to predict the likelihood of breast cancer recurrence and 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 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 outcome or success of clinical trials or studies; the applicability of clinical study results to actual outcomes; the impact of our research on treatment decisions, our beliefs regarding the limitations of current prognostic methods and their effect on treatment of patients; our clinical development strategy; and our ability to develop and commercialize a colon cancer test service and the specific attributes of any such test service. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, including the risks set forth in Genomic Health's Quarterly Report on Form 10-Q for the quarter ended March 31, 2006. 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

Issuer of this News Release is solely responsible for its content.
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