Healthcare Industry News:  Oncotype DX 

Biopharmaceuticals Oncology

 News Release - December 17, 2007

Multiple Studies Presented at San Antonio Breast Cancer Symposium Reinforce Clinical Utility of Oncotype DX(R)

Presentations Provide New Insights into Treatment Impact, Node-Positive Breast Cancer, Measuring ER/PR Scores

REDWOOD CITY, Calif., Dec. 17 (HSMN NewsFeed) -- Genomic Health, Inc. (Nasdaq: GHDX ) today announced results from multiple studies reinforcing the clinical utility of the company's Oncotype DX, a multi-gene expression test to predict the likelihood of recurrence and the likelihood of chemotherapy benefit for a large portion of early-stage breast cancer patients. This research was presented at the 30th Annual San Antonio Breast Cancer Symposium, December 13-15.

"The extensive body of research on Oncotype DX, including data presented in San Antonio this week, along with its recent inclusion in ASCO treatment guidelines, supports the use of Oncotype DX in treatment planning for women with early-stage estrogen receptor-positive breast cancer," said Lori J. Goldstein, M.D., Director of the Breast Evaluation Center at Fox Chase Cancer Center in Philadelphia, Pennsylvania, and author of two Oncotype DX studies.

Eight studies presented at the San Antonio Breast Cancer Symposium evaluated Oncotype DX, including its use in estrogen receptor-positive, node- positive breast cancer; the test's impact on treatment selection and patient satisfaction; reporting of quantitative ER and PR scores within the Oncotype DX report; and a comparison between the Oncotype DX Recurrence Score(TM) and Adjuvant Online, among other presentations.

Positive Results in Node-Positive Disease

* An oral presentation by the Southwest Oncology Group (SWOG) on Thursday, December 13 reported positive results for the Oncotype DX Recurrence Score result in early-stage estrogen receptor-positive breast cancer patients with positive nodes. Researchers analyzed tumor samples from patients in the SWOG/Breast Cancer Intergroup of North America trial that evaluated postmenopausal patients with node positive, hormone receptor-positive breast cancer who were treated with chemohormonal therapy (cyclophosphamide, doxorubicin, 5-fluorouracil, followed by tamoxifen) vs. tamoxifen alone. Chemotherapy did not appear to benefit those with low Oncotype DX Recurrence Score results, despite the presence of positive nodes. Conversely, a large benefit was observed with the addition of chemotherapy in patients with high Oncotype DX Recurrence Score results. These results join a suite of studies that consistently demonstrate the value of the Oncotype DX Recurrence Score result for individualized treatment planning, and show that Oncotype DX may be clinically useful in some patients with hormone receptor positive, node-positive breast cancer.

Oncotype DX Changes Treatment Decisions

Three studies assessing the impact of Oncotype DX on treatment decisions concluded that use of the test resulted in less recommendation for and use of chemotherapy. Collectively, these studies demonstrate the actionable nature of Oncotype DX in its ability to help reduce unnecessary use of chemotherapy, lowering both adverse effects and cost for these patients, while increasing patient confidence in their treatment selection.

* A prospective, multi-institutional study presented Thursday, December 13 by Loyola University Chicago Stritch School of Medicine evaluated 89 patients to determine the psychological impact of Oncotype DX Recurrence Score results on patients' treatment decision-making and anxiety. Use of Oncotype DX changed both physician and patient decisions on adjuvant therapy selection, resulting in less chemotherapy use, decreased patient anxiety and increased patient confidence regarding their treatment decision.

* On Friday, December 14 researchers from the University of Pittsburgh Cancer Institute reported that use of the Oncotype DX assay in patients with estrogen receptor-positive, node-negative early breast cancer over three years significantly decreased the recommendation for adjuvant chemotherapy for patients with low Recurrence Score results, indicating that the assay is being used as intended among oncologists in an academic breast cancer program.

* In a separate study also presented on Friday, December 14, researchers at the University of Pennsylvania evaluated changing practice patterns and frequency of chemotherapy use among node-negative, hormone receptor-positive patients treated in 2003 before the availability of Oncotype DX compared to those treated in 2005 and 2006 after the test was used. The recommendation and use of adjuvant chemotherapy declined significantly from 2003, when it was recommended to 55 percent of patients, to 25 percent in 2005 after physicians started using Oncotype DX.

"Over the past four years, Oncotype DX has continued to demonstrate consistent results across multiple clinical trials, from validation to clinical practice impact," said Steven Shak, M.D., chief medical officer of Genomic Health. "With this latest research, in addition to updated ASCO Guidelines recommending Oncotype DX, it is clear the test is becoming standard practice for physicians and women making important breast cancer treatment decisions."

Reporting of Quantitative Estrogen Receptor and Progesterone Expression with Oncotype DX

* A study presented by Kaiser Permanente researchers on Saturday, December 15 found estrogen receptor (ER) expression, as determined by both immunohistochemistry (IHC) and RT-PCR (as measured by Oncotype DX), was prognostic in a group of ER-positive and ER-negative patients. RT-PCR results were more continuously distributed with a large dynamic range than estrogen receptor expression measured by IHC, which was generally either very high or very low. Among estrogen receptor- positive, tamoxifen-treated patients, only quantitative RT-PCR using Oncotype DX allowed for a risk comparison across levels of estrogen receptor expression, and identified a 2.5-fold increase in survival for those with the highest quantitative estrogen receptor expression. Based on these and other results, Genomic Health plans to provide individual estrogen and progesterone receptor scores as an enhancement to Oncotype DX Recurrence Score reports beginning in early 2008.

Other Oncotype DX Studies

* An oral presentation on Saturday, December 15 showed Recurrence Score results were significantly predictive of recurrence in both node negative disease and node-positive disease, and demonstrated that Oncotype DX provides additional prognostic information beyond that developed by Adjuvant Online.

* A separate study presented on Thursday, December 13 by Istituto Nazionale dei Tumori in Italy demonstrated that Recurrence Score results from a primary diagnosis of breast cancer are also associated with survival in the first two years after recurrence. Specifically, those with low Recurrence Score results experienced longer survival after recurrence.

* Finally, a study presented by Genomic Health on Friday, December 14 reported gene expression profiles as measured by Oncotype DX in histologically characterized breast cancers including ductal, lobular, or mixed, as well as in a number of special histologic subtypes. The study found considerable variation in gene expression both within and between these rarer special subtypes of estrogen receptor-positive invasive breast cancer.

About Oncotype DX

Oncotype DX is 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 breast cancer survival and the likelihood of chemotherapy benefit. Oncotype DX has been extensively evaluated in multiple independent studies involving more than 3,300 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. To date, nearly 7,000 physicians have ordered more than 40,000 tests, and health plans covering over 50 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements and policy decisions. The American Society of Clinical Oncologists (ASCO) recommends 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 http://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 its first test service, Oncotype DX, 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 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 belief that the use of Oncotype DX is indicated in treatment planning for early-stage estrogen receptor positive breast cancer patients, the value provided by using Oncotype DX, the belief that Oncotype DX may be clinically useful in some patients with hormone receptor positive, node positive breast cancer, the ability of Oncotype DX to change treatment decisions, the ability of Oncotype DX to reduce unnecessary chemotherapy and to increase patient confidence in their treatment decisions, the belief that Oncotype DX is becoming standard practice for doctors and patients making treatment decisions, and Genomic Health's plans to provide single gene reporting and the timing of any such product enhancement. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: the applicability of clinical results to actual outcomes; the ability of our test to continue to impact treatment decisions; our ability to increase usage of our tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests and any future tests we may develop; the risk of delay in developing new products or product enhancements; the risks and uncertainties associated with the regulation of our test by FDA; our ability to obtain capital when needed; our history of operating losses; the results of clinical studies and the other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our Quarterly Report on Form 10-Q for the three-month period ended September 30, 2007. These forward- looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: Genomic Health, 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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