REDWOOD CITY, Calif.,
May 18, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced
positive results from a second, larger liquid biopsy feasibility
study demonstrating the Company's ability to detect tumor-specific
DNA in urine, which is expected to enable bladder cancer recurrence
monitoring. The study results, which were presented at the 2015
American Urological Association (AUA) Annual Meeting in
New Orleans, included data from 66
patients who are part of a large ongoing study that has enrolled
nearly 500 patients at 15 sites.
"A non-invasive, urine-based test for monitoring patients for
disease recurrence can improve bladder cancer patient care by
optimizing the use of cystoscopies," said Matthew J. Resnick, M.D., assistant professor
and urologic surgeon, Vanderbilt
University Medical Center, Nashville, Tenn. "A liquid biopsy could make
it less stressful for low-risk patients to comply with active
surveillance, while aiding in earlier detection and more timely
treatment of high-grade recurrences."
It is estimated that early-stage bladder cancer recurs in only
10 to 15 percent of patients in the first year, and in more than
half of patients over time. However, approximately one-third
of all cystoscopies – a procedure using a thin instrument equipped
with a camera and light to look at the inside of the bladder –
generate false positive results.
Genomic Health and its collaborators used the Company's
next-generation sequencing (NGS) and polymerase chain reaction
(PCR) based platforms and refined methodology to target
tumor-specific differential DNA methylation and single nucleotide
variations. In the study, researchers identified tumor-specific DNA
markers in 94 percent of tissue samples and found a strong
association between the same markers in urine. These findings are
expected to enable accurate monitoring for cancer recurrence in the
urine of early-stage bladder cancer patients.
"Building on the positive results from our previous, exploratory
whole genome sequencing, here, we narrowed down our analysis to
specific bladder cancer-related genomic regions
to enable both accurate and cost-efficient detection of
bladder cancer from urine," said Ellen
Beasley, Ph.D., senior vice president, Research and
Development, Genomic Health. "By providing physicians with a
non-invasive tool to accurately assess cancer recurrence, our goal
is to improve patient monitoring and to optimize treatment."
These new results, combined with an upcoming presentation of
more detailed proof-of-concept study results at the American
Association for Cancer Research (AACR) Precision Medicine Meeting
in June, demonstrate Genomic Health's continued progress toward
developing non-invasive tests aimed at individualizing cancer
treatment at every stage of the disease. The Company is on track to
launch its first liquid biopsy test in 2016.
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
early-stage cancer, one of the greatest issues in healthcare today.
The company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of massive
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey, from
diagnosis to treatment selection and monitoring. The company
is based in Redwood City, California, with European
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 value and benefits of
urine-based monitoring of bladder cancer patients; the expectation
that the test results could enable a urine-based test for
monitoring bladder cancer recurrence in early-stage patients, and
the potential benefits of such a test; and the company's belief
that the study results demonstrate continued progress toward
development of non-invasive tests for individualized treatment at
various stages of disease. 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 risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the company's ability to develop and commercialize
new tests, including tests based on liquid biopsy; 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 of competition;
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-Q for the
quarter ended March 31, 2015. These forward-looking statements
speak only as of the date hereof. Genomic
Health disclaims any obligation to update these
forward-looking statement.
NOTE: The Genomic Health logo, Oncotype, Oncotype
DX, Recurrence Score, and DCIS Score 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.