REDWOOD CITY, Calif.,
July 12, 2017 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today announced that
the 15th St. Gallen International Breast Cancer
Conference Expert Panel endorsed the use of genomic tests in
early-stage breast cancer and recognized the Oncotype DX Breast
Recurrence Score® test for its prognostic ability as
well as its value in guiding treatment decisions on adjuvant
chemotherapy for patients with early-stage, endocrine-sensitive,
invasive breast cancer.
In particular, Oncotype DX® was the only test
supported by a majority of panelists (58.6 percent) for its value
in providing information that can help physicians "decide to omit
chemotherapy" in patients with node-positive disease (up to three
nodes). The guidelines, which are reviewed bi-annually, have been
recently published online in the Advance Access section of
Annals of Oncology and will appear in a future print
issue.
"We are pleased that this expert panel once again recognized the
value of the Oncotype DX test. An extensive body of clinical
evidence highlights the unique ability of our test to identify both
patients who can be spared chemotherapy and – importantly – those
who will clearly benefit from it, while providing a positive impact
on healthcare systems," said Calvin
Chao, vice president of global medical affairs at Genomic
Health. "In addition to these updated guidelines, it is encouraging
to see recently published data reinforcing that there is a spectrum
of biology in breast cancer and growing evidence from all research
groups on the importance of more precise estimates of risk and
chemotherapy benefit as provided by the Oncotype DX individualized
Recurrence Score result."
The Oncotype DX Breast Recurrence Score test is incorporated in
all major international guidelines, including NICE, St. Gallen
International Breast Cancer Expert Panel, ESMO, ASCO and NCCN. The
test was also included in the 8th edition of the American Joint
Committee on Cancer (AJCC) criteria for breast cancer staging,
which will be effective in January
2018. This is particularly significant since AJCC has, for
the first time, added molecular markers to staging criteria and
identified Oncotype DX as the only multigene test that can be used
to determine formal staging of breast cancer patients along with
hormonal status (ER, PR), and HER2 status.
Breast cancer is the most common cancer in European
women1 and affects many of them during their years
dedicated to working and raising a family. While chemotherapy is
routinely offered, research shows that less than 10 percent of
patients with early-stage breast cancer actually benefit from
it.2 The Oncotype DX test is designed to facilitate
personalized clinical decisions by providing information about the
biology of an individual breast cancer, with the potential to
deliver financial benefits for healthcare systems. This is
supported by substantial real-world evidence showing that the test
can reduce the number of women undergoing unnecessary chemotherapy
by up to 60 percent.3
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 Recurrence
Score®, has been shown to predict the likelihood of
chemotherapy benefit as well as recurrence in invasive breast
cancer. Additionally, the Oncotype DX Breast DCIS Score™ predicts
the likelihood of recurrence in a pre-invasive form of breast
cancer called DCIS. With more than 750,000 patients tested in more
than 90 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 tests,
visit www.OncotypeIQ.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 help optimize cancer care, including
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 750,000 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™ test. 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 U.S. Private Securities Litigation Reform Act of
1995, including statements relating to the ability of any potential
tests Genomic Health, Inc. may develop to optimize cancer treatment
and the ability of the company to develop and commercialize
additional tests in the future. 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;
the applicability of clinical study results to actual outcomes; the
company's 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; 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 yearly report on Form 10-K for the
quarter ended March 31, 2017. 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,
Oncotype IQ, Oncotype DX Breast Recurrence Score, Recurrence Score,
and Breast Recurrence Score are trademarks or registered trademarks
of Genomic Health, Inc. All other trademarks and service marks are
the property of their respective owners.
GHDX-B
1
http://eco.iarc.fr/EUCAN/Country.aspx?ISOCountryCd=968, last
accessed on 21/06/17
2 Paik et al. J Clin Oncol. 2006 ; Early
Breast Cancer Trialists' Collaborative Group (EBCTCG) et al.
Lancet. 2012.
3 Loncaster J et al., Eur J Surg Oncol 2017
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SOURCE Genomic Health, Inc.