REDWOOD CITY, Calif.,
May 11, 2015 /PRNewswire/
-- Genomic Health (Nasdaq: GHDX) today announced that the 14th
St. Gallen International Breast Cancer Conference Expert Panel, for
the third time, recognized 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, estrogen receptor-positive,
invasive breast cancer. Oncotype DX was the only multi-gene test
accepted with a strong majority of panellists supporting it as a
predictive tool to guide chemotherapy treatment decision making.
The new guidelines were 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."
Standard clinical criteria commonly used for making chemotherapy
treatment decisions prior to the availability of Oncotype DX often
resulted in substantial overtreatment and unnecessary costs to the
healthcare system. Research shows that less than 10 percent 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 It has
been shown through more than 20 studies that testing with Oncotype
DX saves costs across healthcare systems. Recently-presented
results from Ireland4
showed that use of the Oncotype DX test in early-stage breast
cancer reduced chemotherapy use by half, resulting in net cost
savings of nearly €800,000, or approximately $900,000 U.S. dollars.
The clinical validation studies of Oncotype DX in early-stage
breast cancer have shown that the Recurrence Score is prognostic
and predicts the benefit of adding chemotherapy at diagnosis with
long-term follow-up of 10 years. Additionally, the Panel this year
expressed substantial (43.8 percent) support for the prognostic
value of Oncotype DX beyond five years, as it relates to
considering whether to extend hormonal treatment for an additional
five years in some patients.
"We are pleased that the St. Gallen expert panel recognized once
again the unmatched value of Oncotype DX in guiding important
chemotherapy treatment decisions as well as the test's benefit
in better defining who is at greatest risk for late
recurrences and may be considered for extended tamoxifen or
aromatase inhibitor treatment," said Phil Febbo, M.D., chief
medical officer, Genomic Health. "Since our test became
available in 2004, we have served more than half a million patients
in over 80 countries, and our test continues to be recognized in
international treatment guidelines, including NICE, St. Gallen
ESMO®, and AGO in Germany."
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 80 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 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.
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
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.