SOURCE: Genomic Health

Genomic Health

September 22, 2009 03:00 ET

Genomic Health Confirms Consistent Distribution of Oncotype DX® Recurrence Score® Across European, Middle Eastern and U.S. Patient Populations

Study Indicates Less Than 50 Percent of Early-Stage Breast Cancer Patients in Europe and the Middle East Likely to Benefit From Chemotherapy

BERLIN--(Marketwire - September 22, 2009) - Genomic Health, Inc. (NASDAQ: GHDX) today, announced results from the first study to compare the distribution of Oncotype DX® Recurrence Score® results between European, Middle Eastern and United States patient populations. The findings (Abstract 194), confirming that the distribution of Recurrence Scores in EME (Europe and the Middle East) breast cancer patients is consistent with those observed in the U.S., were presented today in a poster at the joint ECCO 15 - 34th ESMO Multidisciplinary Congress in Berlin, Germany.

Oncotype DX measures the expression of 21 genes of an individual tumor to generate a Recurrence Score (RS) result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients. More than 8,000 physicians have used Oncotype DX for more than 100,000 patients in over 40 countries, including Germany, the United Kingdom, France, Spain, Italy, Israel and Greece. Oncotype DX was launched in the U.S. in 2004 where it has since been widely adopted for treating early-stage breast cancer.

"Oncotype DX represents an important step forward in personalized medicine by providing individual information about the benefit of adjuvant chemotherapy for early-stage breast cancer patients," said Professor Nadia Harbeck, MD, Head of Breast Center, University Cologne, Cologne, Germany. "With this test, we can save some patients from unnecessary treatments, while offering chemotherapy to others who will benefit from it."

For this study, researchers at Genomic Health's CLIA certified, CAP accredited laboratory analyzed samples from over 2,676 EME patients, submitted by physicians between January 2004 and April 2009. The distribution of EME scores, when compared to U.S. scores, showed that the recurrence levels were consistent across the low (51 percent EME, versus 52 percent U.S.), intermediate (37 percent EME, versus 35 percent U.S.) and high (12 percent EME, versus 13 percent U.S.) ranges of recurrence. The fact that greater than fifty percent of the patients in the EME samples had low scores is significant as this group of patients has been shown to have little or no benefit from chemotherapy(1).

The table below illustrates the distribution of low, intermediate and high risk between these two regions:

                                EME (n=2731)    U.S. (=99,229)
RS 0-17                              51%             52%
RS 18-30                             37%             35%
RS greater than or equal to 31       12%             13%

"Using Oncotype DX allows me to provide my patients with important additional information related to their individual risk of recurrence and whether they are likely to benefit from chemotherapy," said Paul Dyson, MBBS, BSc, PhD, FRCR, Consultant Clinical Oncologist, Carlisle, U.K. "This data supports the use of Oncotype DX in Europe and I believe we will start to see additional physicians incorporating the test into clinical practice."

"As more physicians outside of the U.S. begin to use Oncotype DX, they can feel confident that the Recurrence Score provides consistent results across varied patient populations," said Gary Palmer, M.D., Vice President, Medical Affairs, Genomic Health. "This study, in combination with the recently published St. Gallen guidelines, which recommend for the first time that validated multigene assays be considered as an adjunct to standard measures in helping determine chemotherapy benefit, further establishes Oncotype DX as an essential component to personalized breast cancer treatment planning."

About Oncotype DX®

The Oncotype DX breast cancer assay 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. To date, more than 8,000 physicians have ordered more than 100,000 tests in over 40 countries. United States government health plans, such as Medicare, and private insurance covering more than 90 percent of U.S. insured lives provide reimbursement for Oncotype DX through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. Recently, the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer recommended that validated multigene assays should be considered as an adjunct to standard measures in helping determine chemotherapy benefit for early-stage breast cancer patients. 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 the Oncotype DX breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health is preparing to launch its Oncotype DX colon cancer test in early 2010. 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 applicability of clinical study results to actual outcomes, the belief the Oncotype DX can save some patients from unnecessary treatments while offering chemotherapy to others who are likely to benefit from it and the belief that the study supports the company's efforts to incorporate Oncotype DX into breast cancer treatment planning in Europe. 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 risk that we may not obtain or maintain sufficient levels of reimbursement for our tests; the risks and uncertainties associated with the regulation of our tests; 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 quarter ended June 30, 2009. 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.

(1) Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen-receptor-positive breast cancer. J Clin Oncol. 2006;24 (23):3726-34.

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