REDWOOD CITY, Calif.,
June 8, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced the
publication of results from the National Cancer Institute's (NCI)
Surveillance, Epidemiology, and End Results (SEER) Registry in
Nature Partner Journals Breast Cancer, a peer-reviewed
journal published by Nature. Published results demonstrated, based
on evidence from over 44,600 breast cancer patients, that the
Oncotype DX® Breast Recurrence Score™ accurately
predicts survival outcomes in patients with node-negative and
node-positive disease in contemporary "real-world" clinical
practice.
Representing the largest report of prospective clinical outcomes
in patients treated based on Oncotype DX, the results in more than
40,000 patients with node-negative disease and more than 4,600
patients with node-positive (up to 3 nodes) breast cancer showed
that, among those with Breast Recurrence Score results less than
18, breast cancer-specific mortality (BCSM) at five years was 0.4
percent in those with node-negative disease and 1.0 percent in
those with node-positive disease. These findings provide
reassurance that these patients can be effectively treated with
hormonal therapy alone without chemotherapy.
"Newly published results from the SEER Registry are consistent
with the clinical validation studies, and confirm and extend the
outcomes results from three other recent studies: TAILORx, Clalit
Health Services and PlanB," said Steven Shak, M.D., chief
scientific officer, Genomic Health. "With unprecedented survival
evidence from multiple large international studies in more than
50,000 patients, Oncotype DX should be recommended and used as
standard-of-care in node-negative disease and in certain patients
with node-positive disease."
Additional Highlights from Nature Partner Journals
Publication of SEER-NCI Study:
- Mortality significantly increased with increasing Breast
Recurrence Score results (p<0.001) in both node-negative and
node-positive disease;
- Among node-positive patients, 57 percent had Breast Recurrence
Score results <18, 36 percent had results 18-30, and 7 percent
had results >31, reinforcing the wide range of tumor biology
revealed by Oncotype DX in node-positive disease; and
- Multiple analyses showed definitively (p<0.001) that
Oncotype DX provided clinically important information on
prospective patient outcomes beyond standard measures.
"The results of this study demonstrate the potential of future
data linkages to enhance the quality, completeness and usefulness
of the SEER data in supporting cancer research and our
broadening understanding of the disease," said Lynne Penberthy, M.D., M.P.H., associate
director of the Surveillance Research Program, NCI's Division
of Cancer Control and Population Sciences.
The publication follows the recent presentation of four new
analyses of the SEER Registry presented at the 2016 American
Society of Clinical Oncology (ASCO) Annual Meeting. Additional data
reconfirmed that Oncotype DX was an accurate predictor of five-year
breast cancer survival in patients with node-positive and
node-negative disease.
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. With
more than 600,000 patients tested in more than 90 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 tests, visit www.OncotypeDX.com,
www.mybreastcancertreatment.org
and www.myprostatecancertreatment.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 cancer, one of the greatest issues in healthcare
today. With its Oncotype IQ™ Genomic Intelligence Platform, the
company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of clinical
and genomic big data into actionable results for treatment
planning throughout the cancer patient journey, from diagnosis to
treatment selection and monitoring. The Oncotype IQ portfolio
of genomic tests and services currently consists of the company's
flagship line of Oncotype DX gene expression tests that have been
used to guide treatment decisions for more than 600,000 cancer
patients worldwide. Genomic Health is expanding its test
portfolio to include additional liquid and tissue-based tests. The
company is based in Redwood City, California, with
international 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. 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: our business model; the regulation of our tests;
the applicability of clinical study results to actual outcomes; our
ability to develop and commercialize new tests and expand into new
markets domestically and internationally; the risk that we may not
obtain or maintain sufficient levels of reimbursement, domestically
or abroad; competition; unanticipated costs or delays in research
and development efforts; our ability to obtain capital when needed;
and the other risks and uncertainties 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 quarter ended
March 31, 2016. 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, DCIS Score, Oncotype SEQ, and Oncotype IQ are
trademarks or registered trademarks of Genomic Health, Inc. All
other trademarks and service marks are the property of their
respective owners.
GHDX-B
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SOURCE Genomic Health, Inc.