REDWOOD CITY, Calif.,
June 5, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced results
from seven Oncotype DX® studies being presented at the
2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
Results include four new analyses from the National Cancer
Institute's (NCI) Surveillance, Epidemiology, and End Results
(SEER) Registry with more than 44,600 breast cancer patients. The
SEER analyses reconfirmed through prospective outcomes data that
the Oncotype DX® Breast Recurrence Score™ is an accurate
predictor of five-year survival in patients with node-positive and
node-negative disease in contemporary "real-world" clinical
practice and revealed disparities in Oncotype DX testing use and
patient outcomes.
"The results of the new analyses of SEER Registry data reinforce
the specific value of Oncotype DX in node-positive disease and in
older women," said Steven Shak, M.D., chief scientific officer,
Genomic Health. "These new data add to unprecedented evidence that
Oncotype DX provides critical information to ensure improved
patient outcomes and less harm, and should be recommended and used
as standard of care in node-negative disease and certain patients
with node-positive disease."
- In node-positive disease, the Breast Recurrence Score added
considerable additional independent prognostic value for five-year
breast cancer survival when reported separately for patients with
micrometastases, one, two or three positive nodes (Abstract
6575).
- In node-negative disease, worse breast cancer survival was
observed in older patients (over age 70) who were tested and had an
intermediate or high Breast Recurrence Score result, contrary to
the general perception that older women tend to have favorable
outcomes. Patients age 70 or older also had lower reported
chemotherapy use, supporting continued examination of the often
reported issue of under-treatment of the elderly (Abstract
574).
- The utilization of Oncotype DX in clinical practice
significantly varied based on age, race, socioeconomic status,
marital status, insurance, tumor grade, tumor size (p<0.01 for
each) and geographic location. Patient age and geographic location
were particularly strong factors that influenced test use. Overall,
about 40 to 50 percent of women who met the guideline criteria for
Oncotype DX had the test, underscoring the opportunity to bring
precision medicine to more patients (Abstract 6552, Abstract
6553).
"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.
Oral Presentation Highlights the Positive Impact of
Oncotype DX on Quality of Care
Investigators at the University of
Michigan assessed the clinical use of Oncotype DX and its
impact on patient experiences in 1,527 invasive breast cancer
patients. The study demonstrated that physician recommendations for
chemotherapy and patient receipt of chemotherapy were consistent
with Breast Recurrence Score results, including in patients with
node-positive disease. The study results indicated that the use of
Oncotype DX is a compelling model for how precision medicine can
markedly improve decision making for treatment of cancer (Abstract
6501).
Other presentations reinforcing the value of Oncotype DX in
personalizing cancer treatment included:
- The five-year clinical outcomes results from the prospective
Phase III PlanB trial, one of the largest contemporary adjuvant
breast cancer trials in Europe,
conducted by the West German Study Group (WSG). Results showed that
patients with low Breast Recurrence Score results had 99 percent
overall survival, consistent with conclusions from TAILORx
(published in The New England Journal of Medicine) and
results from the recently published NCI-SEER Registry study
(Abstract 556).
- Results of a study of Oncotype DX in prostate cancer showed
that the Genomic Prostate Score was a strong predictor of
biochemical and clinical recurrence in intermediate- and high-risk
patients and thus appears to provide improved risk stratification
in this patient population (Abstract 5049).
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.