REDWOOD CITY, Calif.,
March 29, 2017 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced the
presentation of new results from a large multi-center validation
study, which confirmed that the Oncotype DX® Genomic
Prostate Score™ (GPS) is a strong independent predictor of
metastases at 10 years in prostate cancer patients across all
National Comprehensive Cancer Network (NCCN) clinical risk groups.
The clinical validation study data were designated one of the "best
posters" (abstract #352) at the 32nd Annual European
Association of Urology (EAU) Congress in London.
"Now validated for all major near- and late-term endpoints of
adverse pathology, biochemical recurrence, metastasis and prostate
cancer-specific death, Oncotype DX becomes the only genomic test to
provide physicians with an assessment of both the current state and
future risk of their patient's cancer based on biology to help them
confidently decide between active surveillance or surgery," said
Phil Febbo, M.D., chief medical
officer, Genomic Health. "We believe the breadth of clinical
evidence from 22 studies in more than 4,200 patients further
supports the test's broader adoption in the U.S."
Researchers evaluated biopsy tissue from 259 patients in Kaiser
Permanente's Northern California
region, identified from a database of men treated with radical
prostatectomy and diagnosed with low-, intermediate- or high-risk
prostate cancer. The majority of patients (67%) included in this
study had intermediate-risk disease.
Results showed a range of 10-year risk within each NCCN risk
group and confirmed that the GPS was strongly associated with
metastases (p<0.001) in multivariable analysis when compared to
other risk criteria and provided additional independent information
about tumor aggressiveness and long-term outcomes. An additional
key finding was that that no patients with low- or
intermediate-risk prostate cancer and a GPS result of less than 20
developed metastatic disease following radical prostatectomy.
"It is important to seek ways to better understand how to tell a
man with newly diagnosed prostate cancer what his risk of
developing metastatic disease or dying of the disease is," said
Stephen Van Den Eeden, Ph.D., Kaiser
Permanente Division of Research, Oakland,
Calif. "Our study suggests that this test may help some men
and their physicians make better decisions on whether to pursue
active surveillance or receive definitive treatment."
Additional results from this clinical validation study using
Kaiser Permanente data, which also analyzed the GPS performance in
predicting prostate cancer-specific mortality in patients with
early-stage disease, have been accepted for presentation at the
American Urological Association 2017 Annual Meeting in May.
About the Oncotype DX® Genomic Prostate Score™
Designed by Genomic Health based on results from multiple studies
led by Cleveland Clinic and the University of
California, San Francisco, the Oncotype DX Genomic Prostate
Score analyzes 17 genes across four biological pathways from tumor
tissue removed during biopsy to provide an individual score that,
in combination with other clinical factors, further clarifies a
man's risk prior to treatment intervention. The test enables
confident treatment decisions to provide the opportunity for
low-risk patients to avoid prostatectomy or radiation - and their
side effects - while identifying men who need immediate definitive
treatment. To learn more about the Oncotype DX Genomic Prostate
Score, visit www.OncotypeDX.com 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 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 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 other risks and
uncertainties set forth in our filings with the Securities and
Exchange Commission, including our most recent 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, Oncotype, Oncotype
DX, Recurrence Score, DCIS Score, Oncotype SEQ, 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-P
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SOURCE Genomic Health, Inc.