Genomic Health, Inc. Announces Publication of Comprehensive Economic Analysis Confirming Cost-Effectiveness of Oncotype DX™ in the American Journal of Managed Care

Findings Reinforce Value of Recurrence Score Testing and Provide Support for Favorable Reimbursement Coverage Policies

REDWOOD CITY, CA - May 13, 2005 - Genomic Health, Inc. today announced that The American Journal of Managed Care published the results of a comprehensive economic analysis demonstrating that the breast cancer assay, Oncotype DX, which measures gene expression for a 21-gene panel from individual tumor specimens, may improve survival for some patients and can reduce treatment costs when used appropriately with women who have node-negative, estrogen receptor-positive breast cancer. The analysis, "Economic Analysis of Targeting Chemotherapy Using a 21-Gene RT-PCR Assay in Lymph-Node-Negative, Estrogen-Receptor-Positive, Early-Stage Breast Cancer," is based on earlier clinical research findings that show the "Recurrence Score" generated by Oncotype DX more accurately quantifies the likelihood of breast cancer recurrence compared to classification by existing guidelines, and helps predict chemotherapy benefit for these women.

"Even with conservative assumptions in place, the Oncotype DX breast cancer assay can provide economic returns that substantially offset the cost of the test and in some settings may generate net cost savings to health plans while improving overall medical outcomes for patients," said John Hornberger, M.D., M.S., senior research associate, The SPHERE Institute / Acumen, LLC, staff physician of the Department of Veterans Affairs, adjunct clinical professor of medicine, Stanford University, and lead author of the study. "It is rare for a newly introduced technology to demonstrate the ability to improve outcomes for a defined segment of patients and simultaneously increase the economic efficiency of health care delivery in a rigorous analytic model."

The analysis published in AJMC projects the benefits, costs, and cost effectiveness of the Oncotype DX assay based on empirical evidence of its clinical effectiveness. The goal was to evaluate whether adoption of the Oncotype DX test could provide net economic benefits to the health care system. The researchers found that the estimated cost effectiveness of the Oncotype DX assay, when appropriately used to quantify the individual risk for patients with node-negative, estrogen receptor-positive early stage breast cancer, is well within the established range of other generally accepted healthcare technologies funded in the United States.

The analysis evaluated 10-year distant recurrence-free survival and overall survival in patients with lymph node negative, estrogen receptor positive early stage breast cancer, as well as relevant costs associated with the use of the Recurrence Score to reclassify risk of recurrence as compared with risk classification using current National Comprehensive Cancer Network guidelines. Outcomes were evaluated using a common framework for health economic appraisals, the Markov model, which provides a well accepted method of modeling prognosis.

In the absence of reliable methods for assessing recurrence risk on an individual basis, the majority of women with breast cancer have been treated with chemotherapy even though only a small subset may benefit. Oncotype DX provides important information for predicting the likelihood of benefit from chemotherapy in estrogen receptor-positive, lymph node-negative patients. This information is valuable in determining if a patient can safely avoid the cytotoxic effects and high costs of chemotherapy.

Introduced in 2004, the Oncotype DX breast cancer assay represents the first diagnostic gene expression test on the market that provides consistent results across multiple independent trials. The assay has been extensively evaluated in numerous independent studies involving more than 2,600 breast cancer patients, including a large validation study published in the December 30, 2004 edition of The New England Journal of Medicine.

The American Journal of Managed Care is an independent, peer-reviewed publication dedicated to publishing original research in healthcare outcomes and creating a forum for scientific communication in the ever-evolving field of healthcare delivery. The journal is indexed in MEDLINE/PUBMED.

About Genomic Health

Genomic Health, Inc. is an oncology-based biotechnology company that provides clinically validated genomic tests to improve the quality of treatment decisions for patients with cancer. The company employs a sophisticated, quantitative approach to molecular pathology (the Oncotype DX platform) to provide to cancer patients and their physicians individualized genomic information on the likelihood of disease recurrence and response to therapy. The company was founded in August 2000 and provides commercial Oncotype DX services through its CLIA and CAP certified clinical reference laboratory located at its headquarters in Redwood City, California.

The study was sponsored, in part, by Genomic Health, Inc. Drs. Hornberger and Lyman receive funding from Genomic Health, Inc.

Contacts:
Emily Faucette/GHI: 415.946.1066
Lyn Beamesderfer/AJMC: 732.656.1006 (extension 313)

Contact Information

For Investors:
650.569.2281
investors@genomichealth.com

For Media:
650.569.2215
media@genomichealth.com

  

Email Alerts

To sign-up to receive email alerts for press releases, stock information, new calendar events and/or SEC filings click here.

 

Shareholder Tools

  

DISCLAIMER

The information in the press releases should be considered accurate only as of the date of the document or presentation. We disclaim any obligation to supplement or update the information in these documents or presentations.


Forward-Looking Statements

This website contains forward-looking statements. Any statements contained in this website that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks and uncertainties associated with the reimbursement for and adoption of Oncotype DX; commercialization of any future tests; the nature and sources of our revenues; our dependence on collaborative relationships; the regulation of Oncotype DX or any future tests we may develop by the FDA; the attributes of our products; the benefits of personalized medicine and its ability to impact treatment decisions; the outcome and success of clinical trials; the applicability of clinical results to actual outcomes; the company's beliefs regarding the potential benefits that may be obtained from additional tests; and other factors detailed from time to time in Genomic Health's periodic filings with the Securities and Exchange Commission. Genomic Health, Inc. specifically disclaims any obligation to update any forward-looking statements.