- Only test recommended based on its ability to predict
chemotherapy benefit
- Recommendation expanded to include patients with
micrometastatic disease
REDWOOD CITY, California,
Dec. 19, 2018 /PRNewswire/
-- Genomic Health, Inc. (NASDAQ: GHDX) today announced that
the National Institute for Health and Care Excellence (NICE) in the
United Kingdom has issued its
updated guidance again recommending the Oncotype DX Breast
Recurrence Score® test for use in clinical
practice to guide adjuvant chemotherapy treatment decisions for
certain patients with early-stage breast cancer. Further, NICE
expanded its recommendation to include patients with
micrometastases, indicating that some cancer cells have spread to
the lymph nodes.
"Oncotype DX is the only test that provides specific information
about an individual patient's response to chemotherapy, correctly
identifying the important minority of patients who will receive
substantial treatment benefit and the majority of patients who will
not benefit from chemotherapy," said Simon D H Holt, Honorary
Consultant Surgical Oncologist, Peony Breast Care Unit at Prince
Philip Hospital in Llanelli, UK. "This test allows us to target
treatment much more effectively and should be routinely used for
all eligible patients."
The recommendation of the Oncotype DX Breast Recurrence Score
test in NICE's updated guidance is based on the test's unique
ability to predict who will benefit from chemotherapy and who will
not. Importantly, NICE acknowledges Oncotype DX as the only test
that reduces the overall number of patients who receive
chemotherapy, as well as the only test supported by long-term
patient outcomes evidence, including the recently published
landmark TAILORx study. Further, NICE also found the Oncotype DX
test to be the most cost-effective tool in guiding chemotherapy
treatment.
"We believe this positive endorsement from NICE reflects the
growing global recognition of the unique value Oncotype DX
provides," said Torsten Hoof, senior
vice president, international, Genomic Health. "As we continue to
experience an increasing impact of the TAILORx study results on
clinical practice, we believe we are one step closer to broadening
Oncotype DX access through increased reimbursement in Western Europe and around the world."
The predictive value of the Oncotype DX Breast Recurrence Score
test was also recently acknowledged by Germany's health technology assessment body,
the Institute for Quality and Efficiency in Health Care (IQWiG),
which concluded that only the Oncotype DX test has sufficient
evidence to guide breast cancer adjuvant chemotherapy decisions
based on the TAILORx study results.
Additionally, the U.S. National Comprehensive Cancer Network
(NCCN) categorized Oncotype DX as the only "preferred" test for
chemotherapy treatment decision-making for node-negative,
early-stage breast cancer patients in its 2018 updated treatment
guidelines.
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® test, is the only test that 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® test predicts the likelihood of
recurrence in a pre-invasive form of breast cancer called DCIS. In
prostate cancer, the Oncotype DX Genomic Prostate Score®
test predicts disease aggressiveness and further clarifies the
current and future risk of the cancer prior to treatment
intervention. With more than 950,000 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, www.MyBreastCancerTreatment.org or
www.MyProstateCancerTreatment.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 950,000 cancer patients
worldwide. Genomic Health is expanding its test portfolio to
include additional liquid- and tissue-based tests, including the
recently launched Oncotype DX® AR-V7 Nucleus Detect™
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 Private Securities Litigation Reform Act of
1995, including statements relating to the belief that the Oncotype
DX Breast Cancer test is unique in its ability to predict
chemotherapy benefit in early-stage breast cancer; the company's
belief that the Oncotype DX Breast Cancer test is cost effective
and can reduce the cost of treatment in the United Kingdom and in various other health
systems around the world; that the recommendation by NICE will lead
to increased use of the Oncotype DX Breast Cancer test in the
United Kingdom; the applicability
of study results to actual outcomes; and the ability of the
company's tests to impact clinical practice. 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 company's
ability to increase usage of its tests; the company's ability to
successfully commercialize its tests outside of the United States; the company's ability to
compete against third parties; 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 and uncertainties associated with regulation of
the company's tests; the results of clinical studies; the
applicability of clinical study results to actual outcomes; 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, 2018. 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, Breast
Recurrence Score, DCIS Score, Genomic Prostate Score, Oncotype DX
AR-V7 Nucleus Detect, and Oncotype IQ 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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