Healthcare Industry News:  colon cancer test 

Diagnostics Personalized Medicine Oncology

 News Release - July 25, 2011

St. Gallen International Breast Cancer Expert Panel Guidelines Include Oncotype DX(R) as Predictor of Chemotherapy Benefit

New International Guidelines Highlight the Importance of Treatment Recommendations Based on Individual Patient's Underlying Tumor Biology

GENEVA, SWITZERLAND and REDWOOD CITY, CA--(Healthcare Sales & Marketing Network) - Genomic Health, Inc. (NASDAQ:GHDX ) today announced that the 12th St. Gallen International Breast Cancer Conference (2011) Expert Panel distinguishes Oncotype DX® as the multi-gene expression test that predicts chemotherapy benefit in patients with estrogen receptor-positive, HER2-negative breast cancer.

Highlighting the importance of intrinsic biological subtypes within the breast cancer spectrum, the updated guidelines, which are determined bi-annually, have been recently published online in the advance access section of Annals of Oncology and will appear in the August 2011 print issue.

"We're witnessing a transformation in the treatment approach to breast cancer with the identification and better understanding of the fundamental tumor subtypes," says St. Gallen Expert Panel member, professor, Manfred Kaufmann, M.D., Goethe University, Frankfurt, Germany. "We are now at a point where we can truly apply a more personalized approach to our clinical practice improving treatment decisions for our patients and believe results from ongoing prospective trials will continue to support this approach."

Focused on the development of treatment recommendations to improve patient outcomes in the immediate future, the 51-member international St. Gallen Expert Panel concluded that Oncotype DX results "may indicate a prognosis so good that the doctor and patient decide that chemotherapy is not required" in some patients.

According to the new guidelines, although there are several tests that provide prognostic information, where uncertainty remains, only Oncotype DX is included as the multi-gene test that "may also be used where available to predict chemotherapy responsiveness" in estrogen receptor-positive breast cancer. In addition to existing studies that have already been conducted to validate Oncotype DX®, a major ongoing prospective trial called TAILORx will provide further insight on the predictive and prognostic value of the test.

"Inclusion in the St. Gallen's guidelines represents an important recognition of the value of Oncotype DX in enabling more individualized treatment decisions by the international medical community," says Christer Svedman, director, medical affairs in Europe, Genomic Health.

To date, Oncotype DX® has been evaluated in 13 independent clinical studies involving more than 4,000 patients to predict the likelihood of chemotherapy benefit as well as risk for disease recurrence in early-stage breast cancer. Furthermore, 11 studies in five countries including Spain, Germany and the United Kingdom, demonstrate that physicians change decisions to recommend chemotherapy more than 30 percent of the time when Oncotype DX® is used, lowering both adverse effects and costs associated with over-treatment and identifying patients with high Recurrence Score® disease who may not have been offered chemotherapy based on traditional clinical and pathological measures alone.

As of March 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 Oncotype DX® tests.

About Genomic Health and the Oncotype DX® Tests

Genomic Health, Inc. (NASDAQ:GHDX ) is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions.

Its lead product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as risk for disease recurrence in early-stage breast cancer. The test is also validated for use in certain node-positive breast cancer patients. Oncotype DX has been extensively evaluated in thirteen clinical studies involving more than 4,000 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. Oncotype DX is the only test incorporated in published ASCO® and NCCN® breast cancer treatment guidelines for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive.

The Oncotype DX colon cancer test is the first multigene expression test commercially available that has been clinically validated to predict risk for disease recurrence in patients with stage II colon cancer. Five studies involving more than 3,200 patients have been conducted to validate the Oncotype DX colon cancer test.

As of March 31, 2011, more than 10,000 physicians in over 60 countries had ordered more than 200,000 Oncotype DX tests. Genomic Health has a robust pipeline focused on developing tests to optimize the treatment of prostate and renal cell cancers, as well as additional stages of breast and colon cancers. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit To learn more about Oncotype DX tests, visit: and

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the Oncotype DX is significant in changing treatment decisions in early stage breast cancer; the company's belief that the Oncotype DX Recurrence Score cannot be predicted by other factors such as age or individual biomarkers; the company's belief that the Oncotype DX is cost effective and can reduce the cost of treatment; the company's belief that it has the opportunity to advance the quality of cancer treatment decisions and that the inclusion of Oncotype DX in the St. Gallen guidelines will enable greater international utilization of Oncotype DX. 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 and uncertainties associated with the regulation of the company's tests; the impact of competition; the results of clinical studies; the results of cost effectiveness studies; 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 period ended March 31, 2011 . 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

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