REDWOOD CITY, Calif.,
March 20, 2015 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today announced that 11
studies were presented at the 14th St. Gallen
International Breast Cancer Conference, including positive results
from a real-life observational study in Ireland.1 That study demonstrated
that use of the Oncotype DX® test in early-stage breast cancer led
to a 58 percent net reduction in chemotherapy use, resulting in net
cost savings of nearly €800,000, or approximately €1,200 in cost
savings per patient.
These positive findings follow several important international
milestones, including the National Health Service (NHS) access
program enabling public hospitals in England to provide the Oncotype DX test, the
test's reimbursement for early-stage breast cancer patients by the
mandatory health insurance system in Switzerland, and the recent expansion of the
German Association of Gynecological Oncology's (AGO's) treatment
guidelines to now include Oncotype DX for node-positive disease and
late recurrence. Furthermore, the AGO guidelines reconfirmed
Oncotype DX as the only gene expression test that provides
predictive information on the likelihood of chemotherapy benefit
for patients with early-stage, hormone-receptor positive invasive
breast cancer.
"The positive momentum we are experiencing in our European
business reflects Genomic Health's leadership in spearheading the
successful globalization of a value-based laboratory service in
countries where significant market access requires public funding,"
said Brad Cole, chief operating officer and chief financial
officer, Genomic Health. "We believe the increasing evidence of the
value Oncotype DX is delivering to patients and healthcare systems
along with our reimbursement success will fuel our business in
Western Europe, allowing us to
capture a significant opportunity for future revenue growth."
Large Multi-Center Study in Ireland Further Demonstrates Oncotype DX's
Impact on Treatment Decisions and Chemotherapy Use (Abstract
P253)
"Ireland was the first public
healthcare system to reimburse this test in Europe, and the results demonstrate not only
the impact of the personalized information Oncotype DX provides on
treatment decisions, but also the significant cost savings
associated with the use of the test over time," said Janice Walshe, M.D., study lead and consultant
medical oncologist, St Vincent's University Hospital, Dublin, Ireland.
The study analyzed both the clinical and financial impact of the
Oncotype DX test on adjuvant treatment decisions in early-stage
breast cancer patients in the first 18 months since broad public
reimbursement, using real-world data from all comprehensive cancer
centers and 633 patients across Ireland. For the 583 patients with
node-negative disease who were included in the analysis, there was
a 59 percent change in treatment decisions after receiving the
Oncotype DX Recurrence Score® results. The use of the
test led to a 58 percent net reduction in chemotherapy use and net
cost savings of nearly €800,000, or approximately $886,000 U.S. dollars, from the perspective of
the national public payer, the Health Service Executive.
"We are delighted that healthcare systems across Europe are recognizing the value of a
personalized approach to breast cancer treatment, specifically
genomic testing with Oncotype DX," said Denis Horgan, executive director, European
Alliance for Personalized Medicine. "This is encouraging as
decisions based on an individual patient's needs will help to
ensure better patient outcomes. We certainly hope to see such tests
becoming part of routine clinical practice in Europe."
Several other studies presented at the St. Gallen conference
demonstrated the unique value of the Oncotype DX test in optimizing
cancer care in patients with pre-invasive and early-stage invasive
breast cancer, including the following:
Oncotype DX Predicts Late Recurrence in Breast Cancer
(Abstract P264)
A large study analyzing 668 patients in the NSABP B-14 trial
showed that the Oncotype DX test predicts late recurrence up to 15
years after initial tamoxifen therapy. Patients with low Recurrence
Score results would be expected to have limited benefit from
extended tamoxifen beyond five years due to much lower risk for
late distant recurrence. Conversely, patients at greatest risk for
late recurrences based on the Oncotype DX Recurrence Score results
and quantitative estrogen-receptor (ER) score might benefit from
extended tamoxifen.
"As recognized by ASCO's guideline update last June, recent
studies have shown that extending tamoxifen treatment for 10 years
is associated with better outcomes, however, we still need better
tools to identify who those patients are," said Norman Wolmark, M.D., chairman of the National
Surgical Adjuvant Breast and Bowel Project (NSABP). "This study
confirms that Oncotype DX can help better define who is at greatest
risk for late recurrences and the potential to benefit from
extended tamoxifen, as well as those who are at lower risk and will
likely have less absolute benefit from extended tamoxifen and,
thus, could be spared prolonged exposure and risk of long-term side
effects."
Oncotype DX Quantifies Recurrence Risk in Pre-Invasive Breast
Cancer known as DCIS (Abstract P252)
Positive results of the largest genomic study in pre-invasive
cancer, known as DCIS (ductal carcinoma in situ), confirmed that
the Oncotype DX test is a strong, independent predictor of local
recurrence, which could be either invasive breast cancer or DCIS.
The primary analysis included 571 patients who were treated with
breast-conserving surgery, in which the tumor was completely
removed. The results of this second large clinical validation
study, conducted by the Ontario DCIS Study Group of Sunnybrook
Health Sciences Centre in Canada,
demonstrated that the DCIS ScoreTM result quantified the
10-year risk of local recurrence and provided prognostic
information beyond clinical factors such as tumor size and grade.
The analysis clearly identified that the majority (62 percent) of
studied DCIS patients were low risk based on the tumor biology
revealed by the Oncotype DX test. The results are consistent with
those of the original ECOG-ACRIN Cancer Research group clinical
validation study.
Comparison Study Shows Important Distinctions Between
Oncotype DX and Prognostic-Only Tests (Abstract P247)
A study conducted in collaboration with the Athens University
Medical School in Greece and the
University of California San Francisco
and Marin Medical Laboratories in California showed a very low correlation of
0.08 (95% CI -0.19, 0.35) between the information provided by the
Oncotype DX test and the PAM50-based ROR score, highlighting the
potential to misclassify patients if a non-predictive test is used
to make a decision regarding chemotherapy treatment. These findings
are consistent with a 1,017-patient comparison study published in
the Journal of Clinical Oncology, which showed that the Oncotype DX
Recurrence Score and ROR classified patients differently (Dowsett
et al, JCO 2013). The latest comparison underscores that the tests
are not interchangeable.
In addition to the results highlighted above, seven other
studies were presented at this major international breast cancer
symposium, representing Genomic Health's continued contribution to
precision medicine and its adoption worldwide.
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 company's flagship product, the Oncotype DX breast cancer
test, has been shown to predict the likelihood of chemotherapy
benefit as well as recurrence in invasive breast
cancer. Additionally, the test predicts the likelihood of
recurrence in a pre-invasive form of breast cancer called
DCIS. With half a million patients tested in more than 70
countries, the Oncotype DX tests have redefined personalized
medicine by making genomics a critical part of cancer diagnosis and
treatment. To learn more about Oncotype DX breast cancer
tests, visit: www.OncotypeDX.com or
www.mybreastcancertreatment.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 belief that increasing
evidence of the value Oncotype DX is delivering to patients and
healthcare systems along with the company's reimbursement success
will fuel the company's business in Western Europe, allowing the company to
capture a significant opportunity for future revenue growth.
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: adequate funding for the company's test by European
healthcare systems; 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; our
ability to develop and commercialize new tests and expand into new
markets domestically and internationally; 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; the company's ability
to obtain capital when needed 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 annual report on
Form 10-K for the year ended December 31,
2014. 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.
1 Smyth L, Economic Impact of 21-gene Recurrence
Score testing on Early Stage Breast Cancer in Ireland. St. Gallen 2015.
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SOURCE Genomic Health, Inc.