GENEVA, May 11, 2015 /PRNewswire/ -- Genomic Health today
announced that the 14th St. Gallen International Breast Cancer
Conference Expert Panel, for the third time, recognised the
Oncotype DX® breast cancer test for its ability
to provide not only prognostic but also predictive information
regarding the likelihood of chemotherapy benefit for patients with
early-stage, endocrine sensitive, invasive breast cancer.
The Oncotype DX test was the only multi-gene test
accepted with a strong majority of panelists supporting it as a
predictive tool. The new guidelines have been recently published
online in the Advance Access section of Annals of Oncology
and will appear in a future print issue.
"Many newly diagnosed breast cancer patients face the difficult
decision of whether or not to undergo chemotherapy," said Dr
Angelo Di Leo, member of the St.
Gallen Expert Panel and Head of the Medical Oncology Unit at the
Hospital of Prato, Istituto Toscano Tumori, Italy. "A tool like the Oncotype DX
test can be helpful in identifying the group of patients with
endocrine sensitive breast cancer who are likely to derive benefit
from adjuvant chemotherapy."
Criteria currently used for making chemotherapy treatment
decisions in clinical practice may result in substantial
overtreatment and unnecessary costs for the healthcare system.
Research shows that less than 10% of patients with early-stage
breast cancer actually benefit from chemotherapy1,2 and
about one-third of treatment recommendations for early-stage breast
cancer patients change after the use of the Oncotype DX
test.3
More than 20 studies conducted in both developed and emerging
markets have shown that testing with the Oncotype DX test
represents a cost-effective use of healthcare resources. Results
presented recently from a real-life observational study conducted
in Ireland4 showed 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.
Healthcare systems across Europe are recognising the value of the test.
Most recently, the National Health Service (NHS) in England agreed to an access program for the
Oncotype DX breast cancer test. The test is also covered in
Switzerland through the mandatory
health insurance system and is reimbursed by the public insurance
system in Ireland and in half of
the regions of Spain.
"We are pleased that this expert panel recognised once again the
value of the Oncotype DX test. An extensive body of clinical
evidence highlights the unique ability of our test to play a
critical role in breast cancer management by improving the quality
of treatment decisions for patients while providing a positive
impact on healthcare systems," said Calvin
Chao, Senior Director of International Medical Affairs at
Genomic Health.
The Oncotype DX breast cancer test is incorporated in all
major international guidelines, including NICE, St. Gallen
International Breast Cancer Expert Panel, ESMO, ASCO and NCCN.
Since it became available in 2004, more than half a million tests
have been requested by more than 19,000 physicians in over 70
countries.
About Genomic Health
Genomic Health, Inc. is a world-leading provider of genomic-based
diagnostic tests that inform treatment decisions and help to ensure
each patient receives appropriate treatment for early stage cancer.
The company is applying its state-of-the-art scientific and
commercial expertise and infrastructure to translate significant
amounts of genomic data into clinically-actionable results for
treatment planning throughout the cancer patient's journey; from
screening and surveillance, through diagnosis and treatment
selection. The company is based in Redwood City, California with European
headquarters in Geneva,
Switzerland. For more information, please visit,
http://www.genomichealth.com/. To learn more about the
Oncotype DX test, visit: http://www.oncotypedx.com/
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, benefits and
attributes of the company's tests to patients, physicians and
payors. 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; 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 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.
1 Paik S et al. J Clin Oncol 2006;24:3726-34.
2 Early Breast Cancer Trialists' Collaborative Group
(EBCTCG), et al. Lancet. 2012:379;432-444.
3 Albanell, J. et al. ESMO 2012; poster 252PD.
4 Smyth L, Economic Impact of 21-gene Recurrence Score
testing on Early Stage Breast Cancer in Ireland. St. Gallen 2015.
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