REDWOOD CITY, Calif.,
March 25, 2019 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today announced that
new data presented at the 16th St. Gallen International Breast
Cancer Conference in Vienna
reinforce the utility of the Oncotype DX Breast Recurrence
Score® test to optimize chemotherapy recommendations in
patients with early-stage breast cancer with or without lymph node
involvement.
The important role of genomic testing to optimize patient
outcomes in early-stage breast cancer was discussed in a
debate between leading international breast cancer specialists
during the St. Gallen Conference. The experts presented several
case studies showing that genomic testing adds value beyond
clinical pathological factors, and they agreed that there are
substantial differences between the available tests.
"Only a test such as Oncotype DX that has been developed
specifically to be predictive of chemotherapy benefit can identify
the right treatment for the right patient," said Prof. Joseph Gligorov, M.D., of the Breast Cancer
Expert Center at the APHP-Tenon Hospital in Paris, who participated in the panel
discussion. "The practice-changing precision made possible by such
a test can lead to improved quality of care and survival among
breast cancer patients, as well as reduced waste of healthcare
resources by directing chemotherapy only to patients who have a
high likelihood of deriving substantial benefit."
Oncotype DX Data Presentations
An updated analysis of
the Clalit Health Services registry, the largest health services
organization in Israel, was
presented at the Conference. This analysis examined the medical
records of more than 1,300 patients with node-negative breast
cancer applying the Recurrence Score cut point determined by the
landmark TAILORx study. The findings showed that use of
chemotherapy was aligned with Oncotype DX test results and that
patients with Recurrence Score results up to 25, the vast majority
of whom were treated with hormonal therapy alone, had excellent
outcomes at 10 years, with low rates of distant recurrence.
Also presented at the Conference was real-world evidence from a
study in more than 80,000 patients, based on an analysis of data
from the Surveillance, Epidemiology, and End Results (SEER)
registry program of the National Cancer Institute (NCI). The
findings confirmed that the Recurrence Score result is predictive
of chemotherapy benefit in patients with node-negative disease
(p=0.009), with no chemotherapy benefit in patients with Recurrence
Score results up to 25. In patients with node-negative disease and
Recurrence Score results up to 25 not treated with chemotherapy,
the Breast Cancer Specific Survival (BCSS) was greater than 98
percent at nine years. In patients with node-positive disease not
treated with chemotherapy and Recurrence Score results less than
18, BCSS was greater than 97 percent at nine years.
Importantly, this real-world evidence reinforces the paradigm
established by the TAILORx study, which provided definitive
information on how to treat women with node-negative early-stage
breast cancer based on their Recurrence Score results. TAILORx, the
largest randomized adjuvant breast cancer treatment trial ever
conducted, identified the vast majority of women who receive no
substantial benefit from chemotherapy, as well as the important
minority for whom chemotherapy can be life-saving.
Results of two decision impact studies from the UK and the
Czech Republic, highlighting the
value of Oncotype DX to personalize and improve the quality of
clinical decisions, also were presented at the Conference. In the
UK study, clinical practice results from 582 patients with
node-positive disease (one to three positive lymph nodes) showed
that chemotherapy recommendations changed in a significant
proportion of patients following testing with Oncotype DX. In
particular, the test allowed more than 60 percent of patients to be
spared chemotherapy and its associated short- and long-term
side-effects. Conversely, the test identified 23 patients who were
initially advised to undergo only endocrine therapy, but whose
treatment was changed to add chemotherapy based on their Recurrence
Score result. Without testing, these patients would not have
received potentially life-saving chemotherapy treatment.
"In serving more than one million cancer patients around the
world with Oncotype DX, we are delivering on the promise of
precision medicine by improving outcomes, while saving healthcare
systems around the world billions of dollars," said Rick Baehner, M.D., chief medical officer,
Genomic Health. "These new data, based on results from thousands of
patients in the U.S. and Europe, further reinforce
the value and need for broader global access to Oncotype DX
testing."
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® test, is the only test that 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 test predicts the likelihood of recurrence in a pre-invasive
form of breast cancer called DCIS. In prostate cancer, the Oncotype
DX Genomic Prostate Score® test predicts disease aggressiveness and
further clarifies the current and future risk of the cancer prior
to treatment intervention, and the Oncotype DX AR-V7 Nucleus
Detect™ test helps determine which patients with
metastatic castration-resistant prostate cancer (mCRPC) are
resistant to androgen receptor (AR)-targeted therapies. The
Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences
at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic
Health. With more than 1 million 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.OncotypeIQ.com, www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatment.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, including 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 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 over 1 million cancer
patients worldwide. Genomic Health is expanding its test portfolio
to include additional liquid- and tissue-based tests, including the
Oncotype DX® AR-V7 Nucleus Detect™ test. 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, including statements relating to the belief that the Oncotype
DX Breast Recurrence Score test is unique in its ability to predict
chemotherapy benefit in early-stage breast cancer; the company's
belief that the Oncotype DX Breast Recurrence Score test is
cost-effective and can reduce the cost of treatment in health
systems around the world; the applicability of study results to
actual outcomes; and the ability of the company's tests to impact
clinical practice. 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 company's ability to increase
usage of its tests; the company's ability to successfully
commercialize its tests globally; the company's ability to compete
against third parties; 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 and uncertainties associated with regulation of the
company's tests; the results of clinical studies; the applicability
of clinical study results to actual outcomes; 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, 2018. 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, Breast
Recurrence Score, DCIS Score, Genomic Prostate Score, Oncotype DX
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.