REDWOOD CITY, Calif.,
Nov. 1, 2016 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today announced topline
results from a large clinical validation study of its biopsy-based
Oncotype DX® Genomic Prostate Score™ (GPS). The
study, performed in collaboration with a large integrated
healthcare system, met its primary endpoint by demonstrating
that the multi-gene Oncotype DX® test,
assessed in prostate needle biopsy tumor tissue, is a strong
predictor of the development of metastasis and prostate cancer
death in patients with early-stage prostate cancer. With these
new results, the Oncotype DX test becomes the first genomic test
validated in all major short- and long-term end points: adverse
pathology, biochemical recurrence, metastasis and prostate
cancer-specific death.
"As part of our commitment to provide urologists with actionable
biological information to guide treatment decisions, we have
investigated our test's ability to predict all critical features of
tumor aggressiveness in early-stage prostate cancer," said
Phil Febbo, M.D., chief medical
officer, Genomic Health. "Adding to 21 clinical studies
in more than 3,600 patients, we believe this new data will expand
and reinforce the clinical utility of the Oncotype DX test and lead
to increased adoption of the test by physicians and patients making
critical treatment decisions."
The complete data analyses will be submitted for presentations
at major urological meetings in 2017.
Designed by Genomic Health based on the results from multiple
studies led by Cleveland Clinic and University
of California, San Francisco, the Oncotype DX GPS analyzes
17 genes across four biological pathways from tumor tissue removed
during the 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 invasive
treatment.
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 Oncotype DX prostate cancer test identifies which
clinically low-risk patients are eligible for active surveillance,
as well as those who may benefit from immediate treatment by
predicting disease aggressiveness. With more than 700,000 patients
tested in more than 90 countries, Oncotype DX testing has redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about the Oncotype DX
prostate cancer test, 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 assay. 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 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 June 30, 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,
Oncotype DX Genomic Prostate Score, Recurrence Score, DCIS Score,
Oncotype SEQ, Oncotype SEQ Liquid Select, 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
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SOURCE Genomic Health, Inc.