REDWOOD CITY, Calif.,
May 15, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced results
from three studies that show the real-world positive impact of the
Oncotype DX® Genomic Prostate Score (GPS) and the test's value in
managing healthcare costs associated with treatment decisions in
low-risk patients. The data were presented at the 2015 American
Urological Association (AUA) Annual Meeting in New Orleans.
Oncotype DX Prostate Cancer Test Improves Risk Assessment
for 1 in 4 Patients
An analysis of the performance of the Oncotype DX GPS in the
first 4,000 men tested showed that the test refined patient risk
for one in four men across all groups of patients (25.2
percent).
"Our experience with the Oncotype DX prostate cancer assay
accurately mirrors the results of the validation studies and
reconfirms the performance and utility of this test," said
Aaron Katz, M.D., chairman,
Department of Urology, Winthrop-University Hospital,
New York. "This analysis provides
real-life documentation of the test's impact on patient risk
assessment, a key driver for treatment recommendations."
The largest shift in risk assessment was observed among NCCN®
low-risk patients (48.2 percent). Of those patients, 36.9 percent
had more favorable biology consistent with very-low risk, and 11.3
percent of patients had less favorable biology, consistent with
higher-risk disease.
Use of Oncotype DX Can Reduce Cost of Prostate Cancer Care
within Five Years
In a separate study, researchers analyzed Oncotype DX test
results from 200 U.S. prostate cancer patients to see how the
change in their treatment decision based on the GPS results
affected the cost of their treatment. Results showed that immediate
treatment costs declined by more than $5,700 per patient. This reduction in costs was
associated with increased use of active surveillance from 44
percent to 70 percent of the time. These results indicate that
incorporating GPS into treatment decisions can reduce overall
healthcare costs within five years.
"Similar to results we've seen with our breast cancer test,
these new findings in prostate cancer underscore the significant
value that Oncotype DX provides not only to urologists and prostate
cancer patients, but also to the U.S. healthcare system," said
Phil Febbo, M.D., chief medical
officer, Genomic Health. "To date, more than 1,800 urologists have
ordered the Oncotype DX prostate cancer test. With the growing body
of clinical evidence, including published clinical validation and
utility studies focused on men who are candidates for active
surveillance, we believe we are well positioned to achieve
reimbursement, enable broader patient access, and reduce the burden
of early-stage prostate cancer on patients and on the healthcare
system."
Genomic Health Continues to Examine Prostate Cancer
Biology in African-American Men
To further advance the understanding of the use of genomics in
African-American men with prostate cancer, Genomic Health
researchers analyzed data compiled from four different Oncotype DX
prostate cancer test studies involving 138 African-American
patients. Results of this analysis showed that the tumor biology
measured by the Oncotype DX GPS was similar between
African-American and Caucasian men, reinforcing findings from the
second validation study conducted in collaboration with
the Uniformed Services University of the
Health Sciences' Center for Prostate Disease Research
(CPDR).
"Demonstrating the clinical performance of molecular-based
prognostic assays in African-American men is especially important
because prostate cancer appears to be more aggressive in African
Americans, and active surveillance may carry increased risk for
progression," said James Mohler,
M.D., chair, Department of Urology, Roswell Park Cancer Institute,
Buffalo, N.Y. "The North Carolina-Louisiana Prostate Cancer
Project was pleased to contribute to this important multicenter
analysis, which shows that the predictive value of this test is
very similar in African Americans and Caucasians."
Separately, in renal cancer, this week The Lancet
Oncology published the results of an independent, prospectively
conducted clinical validation of a 16-gene signature developed by
Genomic Health to predict disease recurrence after surgery in
patients with early-stage kidney cancer. The study results
demonstrate the importance of utilizing multiple biological
pathways to predict tumor behavior, highlighting Genomic Health's
unique approach to cancer genomics across various cancers.
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 half a million patients tested in more
than 80 countries, the 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 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 benefits of the
company's test to physicians, patients and the healthcare system,
the ability of its tests to change treatment decisions, and the
company's positioning to achieve reimbursement. 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 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 statements.
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.