REDWOOD CITY, Calif.,
July 14, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced that
Breast Cancer Research and Treatment published results from
a second large clinical validation study of Oncotype DX®
in patients with stage 0 breast cancer, also known as DCIS (ductal
carcinoma in situ). The population-based study, conducted by the
Ontario DCIS Study Group, reconfirmed that the Oncotype DX DCIS
Score™ is a strong predictor of local recurrence
(p<0.001), which could be either invasive breast cancer or
DCIS.
"Our study analyzed the impact of the DCIS Score as an
independent predictor of local recurrence in a population cohort of
individuals with pure DCIS treated by breast-conserving surgery
with clear margins," said lead investigator Eileen Rakovitch, M.D.,
FRCP(C), M.Sc., Sunnybrook Research Institute, Institute for
Clinical Evaluative Sciences, Toronto.
Based on a population-based cohort of 828 DCIS tumor samples
collected between 1994 and 2003 in Canada, the primary analysis focused on 571
patients who were treated with breast-conserving surgery alone and
had clear margins. The newly published results of the study
identified that the majority of studied DCIS patients (62 percent)
were low risk based on the tumor biology revealed by the Oncotype
DX DCIS Score. The remaining cases had an intermediate-risk or
high-risk score, and these patients experienced a higher risk of
local recurrence. These findings are consistent with those of the
original ECOG-ACRIN Cancer Research Group clinical validation
study, which demonstrated that the DCIS Score quantified the
10-year risk of local recurrence beyond clinical factors such as
tumor size and grade.
"This new publication, combined with a recently published study
showing that Oncotype DX changes treatment decisions in nearly 30
percent of DCIS patients, supports broader adoption of our test and
provides further confidence to physicians and their patients as
they include the test in treatment decision-making," said
Frederick Baehner, M.D., vice
president, Pathology, Genomic Health.
About Oncotype DX®
The Oncotype DX® portfolio
of breast, colon and prostate cancer tests applies advanced genomic
science to reveal the unique biology of a tumor in order to
optimize cancer treatment decisions. The company's flagship
product, the Oncotype DX breast cancer test, has been shown to
predict the likelihood of chemotherapy benefit as well as
recurrence in invasive breast cancer. Additionally, the
test predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. With half a million
patients tested in more than 80 countries, the Oncotype DX tests
have redefined personalized medicine by making genomics a critical
part of cancer diagnosis and treatment. To learn more about
Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or
www.mybreastcancertreatment.org.
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that address both the overtreatment and optimal
treatment of early-stage cancer, one of the greatest issues in
healthcare today. The company is applying its world-class
scientific and commercial expertise and infrastructure to lead the
translation of massive amounts of genomic data into
clinically-actionable results for treatment planning throughout the
cancer patient's journey, from diagnosis to treatment selection and
monitoring. The company is based in Redwood
City, California, with European headquarters
in Geneva, Switzerland. For more information, please
visit, www.GenomicHealth.com and follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the benefits of the test to
physicians, patients and payors. 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 ability of test
results to change treatment decisions; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; 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 year ended March 31, 2015. 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, Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks
and service marks are the property of their respective
owners.
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SOURCE Genomic Health, Inc.