REDWOOD CITY, Calif.,
March 20, 2017 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced results
from 15 Oncotype DX Breast Recurrence Score® studies
conducted in 12 countries that provide real-world evidence of the
test's ability to change treatment decisions in breast cancer
patients. The new findings, presented at the 15th St.
Gallen International Breast Cancer Conference in Vienna, demonstrate the economic value of the
test across multiple healthcare systems and reinforce the clinical
validation, accuracy and precision of the Breast Recurrence Score™
in various early-stage breast cancer patient populations, including
those with node-positive disease.
"Precision medicine is no longer just a promise – it is a
reality for the more than 700,000 cancer patients tested to date
for whom Oncotype DX has individualized care based on the biology
of their tumor," said Steven Shak,
M.D., chief scientific officer, Genomic Health. "The extensive
scientific evidence on the clinical and health economic value of
the Oncotype DX Breast Recurrence Score is unsurpassed as evidenced
by its inclusion in all major global guidelines. We look forward to
the publication of the updated St. Gallen International Expert
Consensus Panel report, which has recognized Oncotype DX as the
leading test to guide chemotherapy decisions since 2011."
In addition, 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.
New data presented last week at the St. Gallen International
Breast Cancer Conference include:
Three studies involving more than 8,000 node-positive
breast cancer patients showed those with a low Oncotype DX Breast
Recurrence Score (RS) had excellent outcomes at five
years
- An analysis of the Surveillance, Epidemiology, and End Results
(SEER) registry program of the National Cancer Institute (NCI) of
6,768 patients with lymph node-positive disease (including
micrometastases) found that the five-year breast cancer-specific
survival (BCSS) rate was excellent for those with a RS of less than
18, particularly among those with micrometastases and fewer
positive lymph nodes. Five-year BCSS outcomes for those with a RS
less than 18 ranged from 98.9 percent for those with
micrometastases to 92.8 percent for those with four or more
positive nodes. The RS was strongly predictive of BCSS among
patients with micrometastases or one to three positive lymph nodes
(both p<0.001). These findings in node-positive disease were
recently updated and published in Breast Cancer Research and
Treatment, providing further detail on the five-year outcomes
results previously published in Nature Partner Journals Breast
Cancer.
- A study from Clalit Health Services in Israel followed over 700 patients for a median
of 5.9 years. The results showed that patients with a RS less than
18 with micrometastases and one to three positive nodes had very
good outcomes with the rates of distant recurrence of three percent
at five years. The majority of these patients (93 percent) were
treated with hormonal therapy alone.
- A prospective analysis of more than 770 patients from the Plan
B trial conducted by the West German Study
Group in Germany showed that patients with a RS of 11 or
less had an excellent five-year disease free survival rate of 94
percent when treated with hormone therapy alone without
chemotherapy.
Collectively, these results are consistent with two separate
comprehensive reviews conducted by independent physician groups who
have used the Oncotype DX Breast Recurrence Score in clinical
practice when treating node-positive patients. A comprehensive
summary led by Terry Mamounas M.D.,
M.P.H., FACS, UF Health Cancer Center in Orlando, Fla., included seven international
studies involving more than 9,000 patients with node-positive
disease. Additionally, Dr. Jeremy P.
Braybrook, Bristol Cancer Institute, University Hospitals
Bristol NHS Foundation Trust, Bristol,
U.K., reported a pooled analysis of international studies in
385 patients with one to three positive lymph nodes showed that
testing with the Breast Recurrence Score significantly impacted
treatment decisions (43 percent), resulting in a net reduction in
chemotherapy use in real-world clinical practice.
Multiple studies from Germany and France reconfirm clinical and health economic
value of Oncotype DX Breast Recurrence Score, supporting broader
adoption of the test in Western
Europe
- A detailed budget impact assessment in Germany comparing the Breast Recurrence Score
to other prognostic-only genomic tests identified the Breast
Recurrence Score as the test associated with the highest reduction
in chemotherapy use because it appropriately classifies more
patients as low risk than other assays, resulting in net budget
savings of more than EUR 4,001 per
patient.
- Two studies from France,
including a treatment decision analysis based on real-world
clinical experience in 827 patients, demonstrated that the test
significantly reduced the use of chemotherapy by 35 percent.
These results are consistent with findings from a review of
eight other international studies that included more than 2,500
patients and demonstrated that Breast Recurrence Score testing led
to an approximate 40 percent reduction in chemotherapy use in
node-negative breast cancer.
"These new findings, based on results from thousands of patients
in the U.S. and Europe, provide
more evidence of the value of Oncotype DX in deciding whether
chemotherapy is needed or not for women with both node-negative and
node-positive breast cancer," said professor Ian Smith, consultant medical oncologist,
professor of cancer medicine, Royal Marsden Hospital, London. "This genomic test has already spared
thousands of patients from unnecessary chemotherapy and reduced
healthcare costs worldwide."
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 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.