Healthcare Industry News:  Oncotype DX 

Diagnostics Biopharmaceuticals Oncology

 News Release - June 3, 2007

Genomic Health, Inc. Announces Positive Results from First Study Using Oncotype DX(TM) in Node-Positive Breast Cancer Patients

Second Study Underway to Determine If Oncotype DX Predictsthe Magnitude of Chemotherapy Benefit in Node-Positive Breast Cancer Patients

Recommendation to Use Oncotype DX in Node-Positive Breast CancerWill Be Based on Results of Second Ongoing Study


CHICAGO, June 3 (HSMN NewsFeed) -- Genomic Health, Inc. (Nasdaq: GHDX ) today announced positive results of a first study analyzing patient samples from a large trial conducted by the Eastern Cooperative Oncology Group (ECOG), a National Cancer Institute clinical trials cooperative group, in patients with node negative or node-positive breast cancer, all of whom were treated with standard chemotherapy regimens. These findings suggest that the Oncotype DX Recurrence Score (RS) provides accurate information regarding the likelihood of breast cancer recurrence for patients with hormone receptor-positive breast cancer, regardless of whether the patients were node-negative or node-positive. The data were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology (Abstract #526).

Currently, Oncotype DX is used to predict the likelihood of breast cancer recurrence and chemotherapy benefit for patients with estrogen receptor- positive, node-negative early-stage breast cancer, who make up approximately half of newly diagnosed breast cancer cases. Third-party payors covering approximately 125 million lives have reimbursement contracts or policy decisions in place for payment for Oncotype DX in this patient population.

"These results suggest that the individual tumor biology captured by Recurrence Score result is also relevant to patients who are diagnosed with node-positive breast cancer. This is the first of two studies to establish the value of Oncotype DX in the node-positive patients. A second study, currently underway with the Southwest Oncology Group (SWOG), is designed to determine whether the Recurrence Score result predicts the magnitude of benefit of chemotherapy in node-positive breast cancer," said Steven Shak, M.D., chief medical officer of Genomic Health. "This approach mirrors the path we took to validate Oncotype DX in node-negative patients, as well as our mission to generate consistent results across multiple trials."

Study Design & Results

ECOG's original study evaluated 776 patients with early breast cancer who were treated with standard chemotherapy. For this analysis, researchers focused on 465 patients with hormone receptor-positive breast cancer. Of these 465 patients, 262 had no involved lymph nodes and 203 patients' cancer had spread to one to three lymph nodes. Similar to what has been observed in previous studies, there was a wide distribution of Recurrence Score results among these patients; 198 patients had low Recurrence Scores (RS less than 18), 142 patients had intermediate Recurrence Scores (RS of 18 - 30), and 125 patients had high Recurrence Scores (RS greater than or equal to 31).

The Oncotype DX Recurrence Score result was a highly significant predictor of recurrence in chemotherapy-treated patients in this study, regardless of whether they were node-negative (p = 0.0007) or node-positive (p=0.0004). Patients with low Recurrence Score results (RS less than 18) had a very low risk of recurrence (less than or equal to 5% at 5 yrs), while patients with intermediate or high Recurrence Score results had a risk of recurrence that was two to three times greater than those with low recurrence scores.

"These results could impact how we select node-positive patients for adjuvant breast cancer clinical trials," said Joseph Sparano, M.D., director of the Breast Evaluation Center at the Montefiore-Einstein Cancer Center in New York and one of the Eastern Cooperative Oncology Group (ECOG) investigators who coordinated the study. "Patients with low Recurrence Score results seem to have excellent outcomes with standard chemohormonal therapy at 5 years, even when there are positive lymph nodes."

"We're already using Recurrence Score results as an eligibility criterion for selecting high-risk, estrogen receptor-positive, node-negative disease," said George Sledge, M.D., Chair of the ECOG Breast Committee. "Patients with low Recurrence Score results are excluded from our next large adjuvant trial, E5103, because they do so well with endocrine therapy alone."

The study, titled "Prognostic Utility of the 21-Gene Assay in Hormone Receptor (HR) Positive Operable Breast Cancer and 0-3 Positive Axillary Nodes Treated with Adjuvant Chemohormonal Therapy (CHT): An Analysis of Intergroup Trial E2197" (ASCO Abstract #526), was presented Sunday, June 3, 2007 at 2:00 p.m. by first author Lori J. Goldstein, M.D., Director of the Breast Evaluation Center at Fox Chase Cancer Center in Philadelphia, Pennsylvania.

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. To date, over 5,500 physicians have ordered a cumulative total of more than 27,000 tests and approximately 125 million lives are now covered by reimbursement contracts and agreements. 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 its first test service, Oncotype DX(TM), 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 www.genomichealth.com.

About ECOG

The Eastern Cooperative Oncology Group (ECOG) was established in 1955 as one of the first cooperative groups launched to perform multi-center cancer clinical trials. Funded primarily by the National Cancer Institute (NCI), ECOG has evolved from a five member consortium of institutions on the East Coast to one of the largest clinical cancer research organizations in the U.S. with almost 6000 physicians, nurses, pharmacists, statisticians, and clinical research associates (CRAs) from the U.S., Canada, South America, Israel, Ireland and South Africa. Primary member institutions of ECOG are academic medical centers and Community Clinical Oncology Programs (CCOPs). In addition, The Cooperative Group Outreach Program (CGOP) provides the opportunity for community physicians at local area hospitals to participate in ECOG-sponsored trials through affiliation with one of the Group's primary member institutions. These institutions work toward the common goal of controlling, effectively treating, and ultimately curing cancer. Research results are provided to the world-wide medical community through scientific publications and professional meetings.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the findings suggesting that a Recurrence Score result provides accurate information regarding the likelihood of recurrence in hormone receptor positive patients, regardless of node status and the impact clinical study results could have on patient selection in adjuvant breast cancer clinical trials. 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; 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 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 March 31, 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

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