REDWOOD CITY, Calif.,
Dec. 22, 2016 /PRNewswire/ -- Genomic
Health, Inc. (NASDAQ: GHDX) today announced that based on
unparalleled clinical evidence, the American Joint Committee on
Cancer (AJCC) incorporated the Oncotype DX® test in its
recently published Eighth Edition AJCC Cancer Staging Manual.
Representing a rigorous, multi-disciplinary assessment, the updated
criteria identify Oncotype DX as the only multi-gene test with
Level I evidence to determine formal staging of breast cancer
patients, based on clinical evidence in more than 63,000
patients.
"For the first time, AJCC has added molecular signatures to
complement the traditional anatomic features of the disease,
transitioning cancer diagnosis and care to truly personalized
medicine," said Steven Shak, M.D.,
chief scientific officer, Genomic Health. "We believe this
groundbreaking milestone will enhance physicians' ability to
deliver the excellent patient outcomes demonstrated across multiple
prospective studies of the Oncotype DX test."
Effective January 2018, the new
AJCC Prognostic Stage Groups will add the Oncotype DX Breast
Recurrence Score™, hormonal status (ER, PR), and HER2 status to
nodal status, tumor size, and tumor grade for staging breast
cancer. For patients with node-negative disease or micrometastases
in the nodes, a low Oncotype DX Recurrence Score (RS<11)
classifies a patient as having the most favorable Prognostic Stage,
regardless of tumor grade or tumor size (up to five
centimeters).
As part of the implementation process, all AJCC partners,
including the College of American Pathologists (CAP) and the
National Comprehensive Cancer Network (NCCN), will develop and
update protocols and tools to facilitate successful adoption of the
required new staging system rules in 2018. The electronic version
of the Eighth Edition AJCC Cancer Staging Manual is scheduled to be
available the first quarter of 2017.
As stated in the AJCC publication1, "Based on the
best available evidence at this time, the Expert Panel determined
that it was appropriate to incorporate multigene molecular
profiling to incorporate the Oncotype DX score into staging for the
subgroup of patients defined by Arm A of the TAILORx study. These
patients should be staged according to the AJCC Prognostic Stage
Groups. The findings for the ODX (Oncotype DX) test are
supported by Level I Evidence (large-scale prospective clinical
trial data)."
The results of the Trial Assigning
IndividuaLized Options for Treatment
(Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research
Group (ECOG-ACRIN) were published in The New England Journal of
Medicine in 2015. Additionally, the Eighth Edition AJCC
Cancer Staging Manual cites clinical outcomes data from tens of
thousands of patients in the United
States generated by the Surveillance, Epidemiology, and End
Results (SEER) Registry program of the National Cancer Institute
(NCI), demonstrating that patients with low Recurrence Scores have
excellent breast cancer survival at five years.
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 more than 700,000 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.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 help optimize cancer care by
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 700,000 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 assay. 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
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, 2016. 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, DCIS Score, Oncotype SEQ, 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.
GHDX-B
1 AJCC Cancer Staging Manual, 8th Edition,
2016
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/genomic-health-announces-inclusion-of-oncotype-dx-in-the-8th-edition-of-american-joint-committee-on-cancer-ajcc-criteria-for-breast-cancer-staging-300382899.html
SOURCE Genomic Health, Inc.