Genomic Health Announces Oncotype DX(R) Provides Additional Prognostic Benefit
in Patients Assessed With Adjuvant Online
- Comparison Study Confirms Oncotype DX Recurrence Score Result Has Strongest
Association with Breast Cancer Recurrence -
SAN ANTONIO, Dec. 15 /PRNewswire-FirstCall/ -- Genomic Health, Inc.
(Nasdaq: GHDX) today announced positive results from a study showing that the
Oncotype DX Recurrence Score(TM) provides additional prognostic information in
patients with early-stage breast cancer beyond that derived from Adjuvant
Online, an online tool that evaluates clinical variables to help physicians
and patients assess the risks and benefits of getting additional therapy after
surgery. Oncotype DX(R) measures the expression of 21 genes of an individual
tumor to generate a Recurrence Score result that quantifies the likelihood of
recurrence and the magnitude of chemotherapy benefit for a large portion of
early-stage breast cancer patients. The results of the research were
presented orally today at the 30th Annual San Antonio Breast Cancer Symposium.
"This study shows the significant added benefit of genomic analysis with
Oncotype DX, when used in conjunction with the traditional clinical variables
as measured by Adjuvant Online," said Steven Shak, M.D., chief medical officer
of Genomic Health. "These results, combined with updated ASCO treatment
guidelines now recommending Oncotype DX, clearly demonstrate that Oncotype DX
provides critical information for breast cancer treatment planning that is not
apparent by examination of clinical variables alone."
The comparison study assessed 465 patients with hormone receptor-positive
breast cancer from a previous Eastern Cooperative Oncology Group (ECOG) study,
computing both the Adjuvant Online risk estimate and Oncotype DX Recurrence
Score result for each patient. The study found that the Recurrence Score
result was a highly significant predictor of recurrence in both node-negative
disease (p=0.0007) and node-positive disease (p=0.0004). In addition, a low
Recurrence Score result predicted a low likelihood of recurrence regardless of
nodal status.
"In examining the relationship between the Oncotype DX Recurrence Score
and Adjuvant Online, we found that both tools have value in providing crucial
information on the likelihood of breast cancer recurrence," said Peter Ravdin,
M.D., Ph.D., the M.D. Anderson Cancer Center physician who developed the
Adjuvant Online tool and a co-author of the study. "Specifically, the
addition of Oncotype DX Recurrence Score results yielded supplementary insight
on outcomes for breast cancer patients. Used together, we have the
opportunity to more effectively guide personal treatment decisions based on a
woman's individual breast cancer."
About Oncotype DX(R)
Oncotype DX is the first diagnostic multi-gene expression test
commercially available that has clinical evidence validating its ability to
predict the likelihood of breast cancer recurrence, the likelihood of breast
cancer survival and the likelihood of chemotherapy benefit. Oncotype DX has
been extensively evaluated in multiple independent studies involving more than
3,300 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, nearly 7,000 physicians have
ordered more than 40,000 tests, and health plans covering over 50 percent of
U.S. insured lives provide reimbursement for Oncotype DX through contracts,
agreements and policy decisions. The American Society of Clinical Oncologists
(ASCO) recommends 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 additional benefit in treatment planning that is possible by
the use of Oncotype DX and the opportunity to more effectively guide such
treatment decisions by using Oncotype DX in conjunction with an analysis of
clinical variables. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially. These
risks and uncertainties include, but are not limited to: the applicability of
clinical results to actual outcomes; the ability of our test to continue to
impact treatment decisions; our ability to increase usage of our tests; the
risk that we may not obtain or maintain sufficient levels of reimbursement for
our existing tests and any future tests we may develop; the risks and
uncertainties associated with the regulation of our test by FDA; our ability
to obtain capital when needed; our history of operating losses; the results of
clinical studies and the other risks set forth in our filings with the
Securities and Exchange Commission, including the risks set forth in our
Quarterly Report on Form 10-Q for the three-month period ended September 30,
2007. These forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these forward-looking
statements.
NOTE: Genomic Health, 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, +1-415-595-9407, media@genomichealth.com, both of Genomic
Health
