GENEVA, March 21,
2012/PRNewswire/ -- Genomic Health, Inc.
(Nasdaq: GHDX) today announced results of three new
Oncotype DX® studies including data demonstrating the
test's cost-effectiveness within the German and
Hungarian healthcare systems, and Israeli data showing
the test's impact on treatment decisions in
early-stage invasive breast cancer patients with
lymph-node positive status. These findings will be
presented during poster sessions at the 8th European
Breast Cancer Conference (EBCC) in Vienna,
Austria, March 21-24.
"We now have eight clinical studies involving more
than 5,000 patients across Europe, showing
the value the Oncotype DX test brings to patients,
physicians and payors," said Christer
Svedman, director, medical affairs in
Europe, Genomic Health. "As
international use of the Oncotype DX breast cancer test
increases, it's important to not only have strong
clinical data but also to demonstrate that using the test
is cost effective in different healthcare systems."
The Oncotype DX breast cancer test has been shown to
predict the likelihood of chemotherapy benefit as well as
recurrence in early-stage breast cancer. Multiple studies
conducted in Germany, Spain,
the United Kingdom, Israel,
Japan, Australia, and the
United Stateshave shown the use of the test to
change treatment decisions in approximately 30 percent of
patients. Additionally, nine health economic
analyses have consistently demonstrated the cost
effectiveness of Oncotype DX in the assessed healthcare
systems in Europe, Asia,
Israeland North America.
Health Economics Analyses in Germanyand
HungaryDemonstrate Oncotype DX's Cost
Effectiveness
"As physicians, we are challenged to provide quality
patient care while exercising economic sense. Oncotype DX
is a unique tool we can use to help guide treatment
recommendations for early-stage breast cancer patients in
a cost effective manner," said Wolfgang
Eiermann, M.D., professor of gynecology,
Interdisciplinary Oncology Center, Munich,
Germany. "Oncotype DX is already included in
international clinical guidelines such as ESMO, St.
Gallen, ASCO and NCCN(1) and our research demonstrates
that Oncotype DX is cost effective and impacts treatment
decisions ensuring that the right patients benefit from
chemotherapy, while others are spared unnecessary
treatment and associated toxicities."
-
The results of a large prospective German multicenter
study involving 366 patients have shown that use of the
Oncotype DX changed initial recommendations in 33
percent of cases and demonstrate that using the test
would be associated with an increased survival and be
cost effective in Germany. "Using the
21-gene breast cancer assay in adjuvant decision-making
in ER-positive (ER+) early breast cancer (EBC) is
cost-effective: Results of a large prospective German
multicenter study" (Abstract #302) will be
presented on Friday, March 23.
-
Additionally, a health economics analysis from
Hungaryfinds the Oncotype DX compares
favorably with other oncology related health
technologies being utilized in the country and that
using the Oncotype DX assay is likely to be cost
effective in Hungary. "The impact of
chemotherapeutic regimens on the cost-utility analysis
of Oncotype DX assay" (Abstract #347) will be
presented on Thursday, March 22.
Using Oncotype DX in Lymph Node-Positive Patients in
Israelis Likely to Reduce Use of
Chemotherapy
-
In an evaluation of the relationship between the
Recurrence Score® results and treatment decisions in
patients with estrogen receptor-positive,
node-positive, breast cancer in Israel,
researchers found that patients who had the Oncotype DX
test were less likely to be recommended chemotherapy
compared to patients who did not have the test even
when adjusting for variables such as grade and nodal
status (p < 0.001). The study included 282 patients
who received the Recurrence Score and 669 control
patients who did not receive the test.
"Recurrence Score (RS) and treatment
decisions in node-positive (N+), estrogen
receptor-positive (ER+) breast cancer patients in
Israel" (Abstract #433) will be
presented on Friday, March 23.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a global
cancer company focused on the development and
commercialization of genomic-based clinical laboratory
services that analyze the underlying biology of cancer
allowing physicians and patients to make individualized
treatment decisions. Its lead 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 and has been shown to the predict the
likelihood of recurrence in ductal carcinoma in situ
(DCIS). In addition to this widely adopted
test, Genomic Health provides the Oncotype DX colon
cancer test, the first multigene expression test
developed for the assessment of risk of recurrence in
patients with stage II disease. As of
December 31, 2011, more than 10,000
physicians in over 65 countries had ordered more than
265,000 Oncotype DX tests. Genomic Health has a
robust pipeline focused on developing tests to optimize
the treatment of prostate and renal cell cancers, as well
as additional treatment decisions in breast and colon
cancers. In February, the company announced plans
to form a new wholly owned genetics subsidiary to focus
on the commercial applications of the human genome, with
the goal of making commercial services available to
physicians and patients in 2013. The company is
based in Redwood City, Californiawith
European headquarters in Geneva,
Switzerland. For more information, please
visit, www.GenomicHealth.com.
To learn more about Oncotype DX tests, visit: www.OncotypeDX.com
and www.mybreastcancertreatment.org.
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation
Reform Act of 1995, including statements relating to; the
cost effectiveness of Oncotype DXwithin the German and
Hungarian healthcare systems; the ability of the
company's tests to optimize cancer treatment
and impact clinical practice; value the
company's tests are delivering to physicians, payers
and patients; the applicability of cost effectiveness
study results to actual outcomes; the impact of clinical
and cost effectiveness studies on the use of the
company's tests; the ability of the company to
successfully market its products outside of the US; the
ability of the company to develop additional tests in the
future; the scope, success or results of clinical trials
and the timing of such activities; and, the ability of
the company's tests to be adequately reimbursed.
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 and cost effectiveness studies; the
applicability of clinical study results to actual
outcomes; the risks and uncertainties associated with the
regulation of the company's tests by the FDA or
similar agencies around the world; our ability to develop
and commercialize new tests; unanticipated costs or
delays in research and development efforts; our ability
to obtain and maintain reimbursement coverage for our
tests 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 period ended
December 31, 2011. These forward-looking statements
speak only as of the date hereof. Genomic Health
disclaims any obligation to update these forward-looking
statements.
(1)ESMO, ASCO and NCCN are registered trademarks of the
European Society of Medical Oncology, the American
Society of Clinical Oncology and National Comprehensive
Cancer Network, respectively. ESMO, St Gallen, ASCO
and NCCN do not endorse any product or therapy.
SOURCE Genomic Health, Inc.
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