Genomic Health Announces Study Confirming Prognostic Value of Oncotype DX(R) Recurrence...

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Mon Apr 20, 2009 8:01am EDT

Genomic Health Announces Study Confirming Prognostic Value of Oncotype DX(R)
Recurrence Score(R) Result in Japanese Breast Cancer Patients

- Results of International Multi-Center Study Consistent with Suite of U.S.
and European Clinical Studies Evaluating Oncotype DX -

REDWOOD CITY, Calif. and KYOTO, Japan, April 20 /PRNewswire-FirstCall/ --
Genomic Health, Inc. (Nasdaq: GHDX) today announced results of a multi-center
Japanese study demonstrating that the Oncotype DX breast cancer assay had
significant prognostic value in Japanese women with estrogen receptor-positive
early-stage breast cancer.  Oncotype DX identified a large portion of patients
in Japan who had estrogen receptor-positive early-stage breast cancer as
having a low likelihood of distant recurrence.  Researchers from the Japan
Breast Cancer Research Group presented results in an oral presentation at the
2009 Kyoto Breast Cancer Consensus Conference International Convention in
Kyoto, Japan on April 17. 

Oncotype DX has been available in Japan since 2007 via SRL, Inc., the
exclusive distributor of Oncotype DX in Japan. 

"These results highlight the clinical utility of this assay for treatment
planning for early-stage breast cancer across populations, including patients
in Japan with breast cancer," said Masakazu Toi, M.D., Ph.D., Professor of the
Department of Surgery at Kyoto University School of Medicine and a director of
the Japan Breast Cancer Research Group.  "Based on these results, we believe
that Oncotype DX should be integrated into standard breast cancer treatment
planning for patients in Japan."  

Researchers evaluated tumor samples from 200 patients with early-stage,
estrogen receptor-positive, lymph node negative breast cancer, who were
treated with tamoxifen, and who had surgery between 1992 and 1998.  The
Oncotype DX breast cancer assay was performed on all individual tumor
specimens and the continuous Recurrence Score(R) was strongly associated with
the risk of distant recurrence (p<0.001).  In addition, these patients were
categorized into Recurrence Score groups based on the standard cutoff points
of 18 and 31; 48 percent had a Recurrence Score less than 18, 20 percent had a
Recurrence Score between 18 and 30, and 33 percent had a Recurrence Score
greater than or equal to 31.  The distribution of Recurrence Scores in the
Japanese population was similar to that found in previous multicenter studies
performed in the United States.  Finally, as shown consistently across
multiple Oncotype DX studies, the risk of distant recurrence in the group with
a Recurrence Score less than 18 (3% at 10 years) was shown to be significantly
lower than the group with a Recurrence Score greater than or equal to 31 (25%
at 10 years) (p<0.001).  A large proportion of breast cancer patients in Japan
were identified by the Recurrence Score to have a low likelihood of distant
recurrence when treated with tamoxifen alone without chemotherapy.

About Oncotype DX(R) 
The Oncotype DX breast cancer assay is the first and only multi-gene
expression test commercially available that has clinical evidence validating
its ability to predict the likelihood of chemotherapy benefit as well as
recurrence in early-stage breast cancer.  Additionally, the test report
provides quantitative scores for certain individual genes.  The Oncotype DX
breast cancer assay has been extensively evaluated in eleven clinical studies
involving more than 4,000 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.  As of December
31, 2008, 7,500 physicians have ordered more than 85,000 tests, and both
Medicare and private health plans covering approximately 90 percent of U.S.
insured lives provided reimbursement for Oncotype DX through contracts,
agreements or policy decisions.  Both the American Society of Clinical
Oncology (ASCO) 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.  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,
Oncotype DX(R), 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 http://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 and
the belief that Oncotype DX should be integrated into standard breast cancer
treatment planning for patients in Japan. 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 Annual Report on Form 10-K for the year ended December 31, 2008.
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

Investors: Brad Cole, +1-650-569-2281, investors@genomichealth.com, or Media:
Emily Faucette, +1-650-569-2824, media@genomichealth.com, both of Genomic
Health
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