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Genomic Health, Inc.

Genomic Health Reports Favorable Commentary on Value of Multigene Assays From the St. Gallen Expert Consensus Meeting on the Primary Treatment of Early Breast Cancer

Geneva, and Redwood City, California (ots/PRNewswire)

- Guidelines Specify that Validated Molecular Assays Should be
Considered as an Adjunct to Standard Measures in Helping Determine
Chemotherapy Benefit -
Genomic Health, Inc. (Nasdaq: GHDX) today reported that the St.
Gallen International Consensus Panel on the Primary Therapy of Early
Breast Cancer recommended for the first time that validated multigene
assays, such as Oncotype DX(R), should be considered as an adjunct to
standard measures in helping determine chemotherapy benefit for
early-stage breast cancer patients. These new treatment guidelines,
published online in the cancer journal, Annals of Oncology, represent
a significant advancement for the role of validated molecular
diagnostics in breast cancer treatment planning and selection in
Europe.
According to the guidelines, the threshold for recommending
chemotherapy in treating estrogen receptor (ER) positive,
HER2-negative breast cancer is difficult to define. Clinical research
in the United States and other countries shows that information
obtained from multigene assays, including Oncotype DX, leads to a
change in treatment decisions in approximately 30 percent of cases.
Physicians from more than 40 countries currently use Oncotype DX to
predict the likelihood of chemotherapy benefit as well as the
likelihood of recurrence for patients with early stage breast cancer,
in order to make individualized treatment decisions about the
addition of chemotherapy to hormonal therapy.
Oncotype DX was launched in the United States in 2004 where is
has since been widely adopted as standard of care for treating
early-stage breast cancer. Oncotype DX is the only validated
multigene expression assay recommended in both the American Society
of Clinical Oncology (ASCO) and the National Comprehensive Cancer
Network (NCCN) guidelines, and extensively reimbursed in the United
States. To date, physicians have used Oncotype DX for breast cancer
treatment planning in more than 100,000 patients in over 40 countries
worldwide.
"We are pleased that the prestigious St. Gallen International
Consensus recognizes the benefit that validated genomic tests, such
as Oncotype DX, can offer to patients diagnosed with early stage
breast cancer," said Gary Palmer, Vice President of Medical Affairs,
Genomic Health. "We believe these guidelines support the expansion of
Oncotype DX in the European market and should help establish
favorable reimbursement policies, making our test readily available
for physicians and patients in this important region."
Aiming to provide evidence-based, scientifically valid
recommendations for the treatment of early breast cancer in clinical
practice, the St. Gallen consensus guidelines are determined
bi-annually by a panel of more than 30 breast cancer experts from
around the world. This is the first time that a European body of
experts has supported the use of a validated multigene-profiling
assay as an adjunct to high-quality phenotyping of breast cancer in
cases where the indication for adjuvant chemotherapy is uncertain.
"These new guidelines provide further evidence that the
international clinical community sees the value of advanced molecular
diagnostics in helping make more informed, individualized breast
cancer treatment decisions," said Dr. Joseph Gligorov, Tenon
Hospital, Paris. "More patients for whom the prognostic evaluation is
still uncertain with the classical and optimal pathological tools,
should now be offered the opportunity to benefit from these new
tests, as it provides both physicians and patients with valuable,
accurate information about their individual cancer and greater
confidence in treatment selection."
About Oncotype DX(R)
The Oncotype DX breast cancer assay is the only multigene
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 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. 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 company's belief that inclusion
of the use of validated multigene assays such Oncotype DX in the St.
Gallen guidelines supports the expansion of Oncotype DX in Europe,
that inclusion of these types of tests in such guidelines may also
help establish favorable reimbursement policies in Europe, and the
company's plans to commercialize a test for colon cancer and the
proposed timing of such commercialization. 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 Oncotype
DX may not receive adequate reimbursement coverage in Europe, risks
associated with international operations, the risks and potential
delays associated with commercialization of a new test; the risks and
uncertainties associated with the regulation of the company's 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
March 31, 2009. These forward-looking statements speak only as of the
date hereof. Genomic Health disclaims any obligation to update these
forward-looking statements.

Contact:

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