REDWOOD CITY, Calif.,
Feb. 16, 2017 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) announced today the
presentation of results from four studies evaluating the clinical
value and utility of its Oncotype DX® Genomic Prostate
Score™ (GPS) in the management of early-stage prostate
cancer. Collectively, these new data highlight the test's ability
to predict disease aggressiveness and refine risk stratification
across National Comprehensive Cancer Network (NCCN) clinical risk
groups.
"We now have 22 clinical studies, involving more than 4,200
prostate cancer patients, that distinguish Oncotype DX as the only
test developed specifically for men who are deciding between active
surveillance or definitive treatment. The test is validated to
provide individualized information about both the current state and
future risk of patients' prostate cancer," said Phil Febbo, M.D., chief medical officer, Genomic
Health. "Together with the recently published economic analysis
demonstrating substantial cost savings of more than $2,200 per patient tested, the data presented
will support increased adoption and reimbursement of Oncotype DX as
physicians aim to bring precision medicine to their prostate cancer
patients."
Kaiser Permanente Clinical Validation Study Confirms Oncotype
DX GPS Predicts Biochemical Recurrence Across Full Spectrum of
Prostate Cancer, Providing Improved Risk Stratification Beyond
Clinical Risk Assessment
A large clinical validation study, conducted in collaboration
with Kaiser Permanente Northern California, has reconfirmed that
the Oncotype DX GPS is a strong independent predictor of
biochemical recurrence (BCR), a rise in prostate-specific antigen
(PSA) in patients following surgery, which is a longer-term outcome
measure of aggressive disease. To evaluate whether the GPS predicts
BCR across the full spectrum of clinical risk as defined by NCCN
criteria, researchers used Kaiser's database of 6,184 radical
prostatectomy-treated men diagnosed with very low-, low-,
intermediate- and high-risk prostate cancer. Results showed that
the GPS was strongly associated with BCR both alone (p<0.0001)
and after adjusting for PSA, clinical stage and central biopsy
Gleason Score (p=0.002). The
association between the GPS and BCR was similar within different
racial groups and consistent with previously published findings
from the study conducted in collaboration with the Center for
Prostate Disease Research in 2014.
"Biochemical recurrence following surgery identifies men for
whom the surgery was not curative. Understanding a patient's
individual risk for developing biochemical recurrence after
treatment helps physicians and patients make well-informed
treatment decisions," said Stephen Van Den
Eeden, Ph.D., Kaiser Permanente Division of Research. "Our
study revealed a strong association between the GPS result and
biochemical recurrence that remained significant in multivariable
analysis, thus demonstrating that Oncotype DX adds additional value
to existing clinical criteria."
Additional data from the clinical validation study with Kaiser
Permanente, including results of the analysis of the performance of
the GPS in predicting the development of metastasis and prostate
cancer death in patients with early-stage disease, have been
accepted for presentation at future major urological meetings.
Prospective Study Demonstrates Oncotype DX GPS Is an
Independent Predictor of High-risk Surgical Pathology (HRSP) in Men
with Clinically Low-risk Disease
In previous retrospective cohorts, the GPS was validated as a
predictor of adverse pathology and BCR in prostate cancer patients
treated surgically with radical prostatectomy. In this new ongoing
prospective observational study, conducted in a real-world,
community healthcare setting, researchers analyzed the association
between the GPS and HRSP in 122 men who elected to receive radical
prostatectomy for initial disease management.
Results showed that the GPS was a significant, independent
predictor of HRSP (p=0.018) across very low-, low- and
intermediate-risk patients. The GPS remained significant after
adjusting for NCCN risk group. These findings suggest that the test
may be valuable in treatment planning for men with clinically
low-risk prostate cancer who are at risk for HRSP and may need to
consider adjuvant therapy after surgery.
Large Study Demonstrates that Medical Conditions Common in
Prostate Cancer Patients Do Not Influence the Oncotype DX
GPS
Validated molecular biomarkers can improve risk stratification
in newly diagnosed patients with prostate cancer, but it is
important to understand if biomarkers are influenced by common
coexisting clinical conditions. Using data from the Center for
Prostate Disease Research, researchers explored the association
between the GPS and comorbidities – including obesity, diabetes
mellitus, hypertension, hypercholesterolemia, coronary artery
disease and low testosterone – in a cohort of 389 surgically
treated men with clinically low-risk prostate cancer.
Results showed that there was no significant difference in GPS
results between men with or without obesity, hypertension,
hypercholesterolemia, diabetes mellitus or lower testosterone.
These findings support the value of using the test in eligible
patients, even if they have these health conditions.
Study of Veterans Finds Oncotype DX GPS Helps Physicians
Identify Appropriate Candidates for Active Surveillance while
Finding Patients with Higher-risk Prostate Cancer
Active surveillance is a recommended management approach for
low-risk prostate cancer, and studies have shown variable rates of
active surveillance in the Veterans Administration (VA). This
prospective study was conducted to determine treatment patterns in
veterans tested with Oncotype DX and those who were not tested to
help further standardize the care of early-stage prostate cancer. A
retrospective medical chart review of 200 patients at six VA
medical centers across the country was compared to treatments from
a prospective study of 190 veterans who were offered Oncotype DX at
the same centers.
Results showed that use of active surveillance was higher (74
percent) in veterans who received Oncotype DX than in veterans who
did not (62 percent), with the largest increase observed in
low-risk patients. The use of the test also helped improve risk
stratification by identifying 24 patients who had more favorable
pathology and 13 patients who had less favorable pathology than
would be expected using NCCN criteria alone.
The Department of Veterans Affairs recently granted a five-year
contract for Oncotype DX tests to be included in the VA Federal
Supply Schedule (FSS) as part of cancer management services for
patients diagnosed with early-stage breast or prostate cancer.
Genomic Health will continue to work with VA hospitals to bring
precision medicine to newly diagnosed cancer patients throughout
the network of more than 150 centers in the United States.
About the Oncotype DX® Genomic Prostate Score™
(GPS)
Designed by Genomic Health based on results from
multiple studies led by Cleveland Clinic and the University of California, San Francisco, the
Oncotype DX GPS 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
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 Genomic Prostate Score (GPS) 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 GPS,
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: the results of clinical studies and their impact on
reimbursement and adoption of the company's tests; the
applicability of clinical study results to actual outcomes; the
company's ability to develop and commercialize tests and expand
into new markets domestically and internationally; the risk that
the company has all rights necessary to commercialize its tests;
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; 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 September 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, Genomic Health, Oncotype,
Oncotype DX, Genomic Prostate Score, 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-P
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SOURCE Genomic Health, Inc.