Genomic Health Announces Commencement of QUASAR Clinical Validation Study for Oncotype...

Genomic Health Announces Commencement of QUASAR Clinical Validation Study for
Oncotype DX(R) Colon Cancer Assay

- Company to Provide Update on Pipeline Efforts at 27th Annual J.P. Morgan
Healthcare Conference -

REDWOOD CITY, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Genomic Health, Inc.
(Nasdaq: GHDX) announced today that it has initiated an independent clinical
validation study for its 18-gene Oncotype DX(R) colon cancer assay. Utilizing
more than 1,200 patient samples from the landmark QUASAR trial, the validation
study will use prospectively defined endpoints to assess the clinical utility
of the Oncotype DX colon cancer assay to predict likelihood of recurrence for
stage II colon cancer patients treated with surgery alone and the magnitude of
treatment benefit with chemotherapy following surgery. Results from the study
are expected to be reported in the second half of 2009.

Stage II colon cancer (also known as Dukes' Stage B) affects an approximately
30-40,000 people each year in the United States and the current treatment
paradigm is unclear. About a third of patients receive adjuvant chemotherapy,
usually 5-fluorouracil/leucovorin (5FU/LV) or combinations that include
5FU/LV; however, research indicates that only 2-4 percent benefit from this
treatment, which has significant associated toxicity. While there are
existing clinical markers traditionally associated with higher-risk in colon
cancer patients, there is no clinically validated genomic test available that
predicts the likelihood of recurrence or magnitude of chemotherapy benefit for
individual patients.

"There is a critical need for more targeted approaches in treating the tens of
thousands of patients with stage II colon cancer and the initiation of this
study brings us one step closer to delivering a tool that may do that," said
Steven Shak, M.D., chief medical officer, Genomic Health. "Over the past two
years we have partnered with the National Surgical Adjuvant Breast and Bowel
Project (NSABP) and the Cleveland Clinic Foundation to evaluate more than
1,800 patients and 760 candidate genes to select the final 18-gene set for the
Oncotype DX colon cancer assay. In developing this assay we have applied the
same rigor and technology used to validate the Oncotype DX breast cancer
assay, a test that has helped guide treatment decisions for more than 75,000
women with early-stage disease."

To date, Genomic Health has completed four development studies to identify and
select the 18 genes for the Oncotype DX colon cancer assay. The validation
study is utilizing samples from QUASAR, the largest study of its kind. An
international, multi-center trial, QUASAR examined the benefit associated with
adjuvant 5FU/LV for patients with stage II colon cancer. The majority of
samples for this analysis of the Oncotype DX colon cancer assay are from the
United Kingdom.

Unlike the Oncotype DX breast cancer assay that captures both recurrence and
treatment benefit in one Recurrence Score, the prognostic and predictive genes
in the colon cancer assay do not overlap. As such, this colon cancer assay
was designed to generate both a prognostic Recurrence Score and predictive
Treatment Score. Researchers will evaluate the association of the Recurrence
Score with recurrence in stage II colon cancer patients treated with surgery
alone. They will also evaluate the association of the Treatment Score with
the magnitude of chemotherapy benefit in patients treated with adjuvant 5FU/LV
chemotherapy.

"In the absence of reliable prognostic and predictive tools to select stage II
colon cancer patients for adjuvant chemotherapy, over- and under-treatment
present significant challenges," said Alan Venook, M.D., Professor of Clinical
Medicine, Gastrointestinal Oncology Research Program at UCSF Medical Center.
"With increasing numbers of people being diagnosed with early-stage disease, a
well-validated predictive or prognostic test could be very useful in helping
us optimize treatment plans for these patients, potentially sparing them from
chemotherapy they do not need."

As previously announced, Genomic Health will present at the 27th Annual
JPMorgan Healthcare Conference in San Francisco on Wednesday, January 14 at
10:30 a.m. Pacific Time. To access the live and subsequently archived webcast
of the presentation, visit the Investor Relations section of Genomic Health's
Web site at http://investor.genomichealth.com. Please connect to the Web site
at least 15 minutes prior to the beginning of the presentation to allow for
any necessary software downloads. An archived replay will be available for
three months beginning 24 hours after the live presentation.

About Oncotype DX(R) breast cancer assay
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. To date, 7,500
physicians have ordered more than 75,000 tests, and both Medicare and private
health plans covering approximately 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 (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 company's expectation regarding the timing of reporting
results of the validation study, the company's belief that the initiation of
the clinical validation study brings it closer to delivering a tool that may
lead to more targeted approaches to treating stage II colon cancer, and the
potential utility, attributes or impact of a predictive or prognostic test for
stage II colon cancer. These risks and uncertainties include, but are not
limited to: the results of the clinical validation study; delays or
difficulties in completion of the clinical validation study; the applicability
of clinical study results to actual outcomes; the risk that the company may
not obtain sufficient levels of reimbursement for any future tests it may
develop; the company's ability to develop and commercialize new products; the
risks and uncertainties associated with the regulation of the company's tests
by FDA; the company's ability to obtain capital when needed; the company's
history of operating losses and the other risks set forth in its filings with
the Securities and Exchange Commission, including the risks set forth in the
company's Quarterly Report on Form 10-Q for the three-month period ended
September 30, 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, Inc.

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, Inc.