REDWOOD CITY, Calif.,
March 24, 2017 /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 the
peer-reviewed journal Breast Cancer Research and Treatment,
reconfirming the value of the Oncotype DX Breast Recurrence
Score® in guiding chemotherapy treatment decisions in
certain node-positive patients.
Consistent with previously published findings in Nature
Partner Journals Breast Cancer, the new SEER Registries
analysis demonstrates that breast cancer patients with limited
node-positive disease who have low Breast Recurrence Score™ (RS)
results have an excellent chance of breast cancer-specific survival
(BCSS). These data, along with results from 14 additional
Oncotype DX® studies in breast cancer patients, were
also presented at the 15th St. Gallen International
Breast Cancer Conference in Vienna.
"This population-based study is valuable proof that the RS
'works' not just in clinical studies but in the real world, and in
patients with node-negative and node-positive breast cancers," said
Harold J. Burstein, M.D., Ph.D.,
Dana-Farber Cancer Institute and Harvard
Medical School. "It will help clinicians and patients feel
yet-more-confident in using the Breast Recurrence Score to make
decisions about chemotherapy treatment in early-stage breast
cancer."
Representing the largest report of clinical outcomes in
node-positive patients treated based on Oncotype DX, the study of
6,768 patients with lymph node-positive breast cancer showed that
RS results were strongly predictive of BCSS (p<0.001). Most
importantly, five-year BCSS rate was excellent (> 97 percent)
for those with limited nodal involvement and a score of less than
18. These findings provide reassurance that these patients can be
effectively treated with hormonal therapy alone without
chemotherapy.
"We now have prospective outcomes data across multiple studies,
including the SEER Registries, demonstrating that not all patients
with positive nodes have aggressive disease and that patients with
up to three positive nodes and Breast Recurrence Score results of
less than 18 can be effectively treated with hormonal therapy alone
and spared the toxicity of chemotherapy," said Steven Shak, M.D., chief scientific
officer, Genomic Health. "These data support wider adoption of
Oncotype DX in many node-positive patients to eliminate
overtreatment and unnecessary toxicities in the low biologic-risk
group."
Separately, in node-negative breast cancer, the American
Joint Committee on Cancer (AJCC) recently incorporated the
Oncotype DX test in its updated published Eighth Edition
AJCC Cancer Staging Manual, identifying Oncotype DX as the only
multi-gene test with Level I evidence to determine formal staging
of breast cancer patients, based on prospective outcomes in more
than 63,000 patients.
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 Recurrence
Score®, has been shown to predict the likelihood of
chemotherapy benefit as well as recurrence in invasive breast
cancer. Additionally, the Oncotype DX Breast DCIS Score™ predicts
the likelihood of recurrence in a pre-invasive form of breast
cancer called DCIS. With more than 700,000 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 or
www.MyBreastCancerTreatment.org.
About Genomic Health
Genomic Health, Inc.
(NASDAQ: GHDX) is the world's leading provider of genomic-based
diagnostic tests that help optimize cancer care by addressing the
overtreatment of the disease, 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 700,000 cancer patients worldwide. Genomic
Health is expanding its test portfolio to include additional
liquid- and tissue-based tests, including the recently launched
Oncotype SEQ® Liquid Select™. 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 applicability of clinical
study results to actual outcomes; the impact of results from
clinical studies on market adoption and utilization of Oncotype DX®
tests, our ability to develop and commercialize new tests and
expand into new markets domestically and internationally;
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-K for the
year ended December 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, Genomic Health,
Oncotype, Oncotype DX, Breast Recurrence Score, Recurrence Score,
DCIS Score, Oncotype SEQ, Liquid Select, Genomic Prostate Score,
Oncotype AR-V7 Nucleus Detect 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.