REDWOOD CITY, Calif.,
Feb. 5, 2015 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) announced today that,
as of April 1, 2015, the Oncotype
DX® test will be available to eligible breast
cancer patients through the National Health Service (NHS) in
England as the only multi-gene
breast cancer test recommended by the National Institute for Health
and Care Excellence (NICE) for use as an option to assist in
chemotherapy treatment decision-making.
The access program enables NHS hospitals to provide genomic
testing to some of their patients by implementing the NICE final
guidance, which recommends Oncotype DX as the only breast cancer
test for use as an option to assist treatment decision-making in
patients with early-stage, hormone receptor-positive, HER2
negative, invasive breast cancer.
In setting up the program, NHS England recognized the conclusion
of NICE that use of Oncotype DX in patients "at intermediate risk
of distant recurrence, when the decision to prescribe chemotherapy
remains unclear, would represent a cost-effective use of NHS
resources."
"The improved access to a test that allows for a better
understanding of individual tumor biology is an important step
forward to personalized care for UK breast cancer patients," said
Nigel Bundred, M.D., professor in
surgical oncology, University Hospital of South Manchester NHS
Foundation Trust. "Having this knowledge can give us greater
confidence in recommending a treatment plan best suited for an
individual patient which decreases the complications of treatment
without compromising survival. The Oncotype DX breast cancer
test should be routinely used for all eligible patients throughout
the country."
Criteria currently used for making treatment decisions in
clinical practice in England may
result in substantial overtreatment and unnecessary costs for the
healthcare system. Research shows that fewer than 10 percent of
patients with early-stage breast cancer actually benefit from
chemotherapy1, while almost one-third of treatment
recommendations for early-stage breast cancer patients in the UK
change after the use of the Oncotype DX test.2 The
Oncotype DX breast cancer test is the only genomic test validated
for its ability to predict the likelihood of chemotherapy benefit
as well as risk of recurrence in early-stage breast cancer, which
has led to its inclusion in all major international guidelines
(ASCO®, NCCN®, St. Gallen and ESMO).
"The NHS decision brings us an important step closer to
achieving our goal of improving the quality of treatment decisions
for cancer patients worldwide," said Brad
Cole, chief operating officer and chief financial officer,
Genomic Health. "In the past few years, more than 3,500 women in
the UK have used the Oncotype DX test, and we believe the latest
agreement will facilitate quick adoption throughout England."
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 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 the
company's test should be used for all eligible patients in the
country; the belief that the agreement with NHS will facilitate
quick adoption in England; the
benefits and attributes of the company's tests to physicians and
patients; the attributes and focus of the company's product
pipeline; the company's belief that it is applying its
infrastructure and expertise to lead the translation of genomic
data into clinically-actionable results; and the applicability of
clinical study results to actual outcomes. 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 NHS England; 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 September 30, 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.
NCCN® and NCCN Guidelines are registered trademarks of
the National Comprehensive Cancer Network. ASCO® is a
registered trademark of the American Society of Clinical Oncology.
NCCN and ASCO do not endorse any therapy or product.
1
Paik S, et al. J Clin Oncol 2006; Early
Breast Cancer Trialists' Collaborative Group, et al. Lancet
2012
|
2
Holt S, et al. Br J Cancer.
2013.
|
Logo -
http://photos.prnewswire.com/prnh/20130425/SF01493LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/following-nices-exclusive-recommendation-nhs-england-agrees-to-access-program-for-oncotype-dx-breast-cancer-test-300031258.html
SOURCE Genomic Health, Inc.