REDWOOD CITY, Calif.,
June 14, 2016 /PRNewswire/
-- Genomic Health, Inc. (Nasdaq: GHDX) today announced the
commercial launch of Oncotype SEQ™ Liquid Select, the first of
several non-invasive liquid biopsy tests that the company plans to
deliver through its Oncotype IQ™ Genomic Intelligence Platform.
Oncotype SEQ is a blood-based test that uses next-generation
sequencing to identify and assess actionable genomic alterations in
a panel of 17 select genes to inform the treatment of stage IV
solid tumors, including lung, breast, colon, melanoma, ovarian, and
gastrointestinal stromal tumors.
The test is designed to provide clinically actionable
information focused on genomic markers that have either been
included in National Comprehensive Cancer Network
(NCCN®) guidelines or associated with sensitivity or
resistance to relevant FDA-approved therapies. The test can also
match eligible patients with actively enrolling Phase II-IV
clinical trials specific to their tumor type.
"As the world's leading provider of genomic-based cancer
diagnostic tests, we are uniquely positioned to make a significant
impact in the field of liquid biopsy with Oncotype SEQ, the newest
clinically actionable test in our Oncotype IQ portfolio," said Phil
Febbo, M.D., chief medical officer, Genomic Health. "This
blood-based test will provide oncologists with important genomic
information reported in a manner that will allow efficient
interpretation and identification of potential treatment options.
With our unique and extensive experience in the commercialization
and reimbursement of advanced diagnostics, Genomic Health is
leveraging its world-class channel to expand the delivery of
precision medicine to physicians and patients beyond the research
setting."
By analyzing cell-free DNA (cfDNA) isolated from a patient's
blood through a simple blood draw, Oncotype SEQ examines
tumor-derived genomic alterations that are associated with
malignant transformation and response or resistance to therapy.
Using unique bioinformatics methodology, the test detects the four
major types of variants with very high sample-level sensitivity and
specificity. The comprehensive Oncotype SEQ report provides
physicians with important molecular alterations information in a
streamlined format that facilitates interpretation and connection
to potential treatment options.
"Liquid biopsy assesses cancer changes through a simple blood
draw, a desirable choice for many patients, as it is a minimally
invasive way to capture tumor genomic alterations and heterogeneity
with the potential to be more cost- and time-efficient," said
Lee Schwartzberg, M.D., chief,
Division of Hematology Oncology, University of
Tennessee. "Oncotype SEQ has robust analytical performance
representative of the targeted patient population tested. Armed
with this clinically meaningful information, Oncotype SEQ will
allow physicians to be more effective and efficient in exploring
treatment and clinical trial options for late-stage cancer
patients."
The initial phase of the targeted launch will be focused on
select clinics for the treatment of stage IV lung cancer patients.
Liquid biopsy is a particularly viable option for lung cancer
patients due to the difficulty and risk associated with lung tissue
biopsy and the number of clinically actionable alterations. With
successful analytical validation results being submitted for
presentation, Genomic Health has launched a global, multi-center
clinical concordance study as part of the company's goal to
establish further evidence to support reimbursement.
By delivering insights into targeted therapy options, Oncotype
SEQ Liquid Select is designed to address the needs of more than
350,000 patients who recur or present with late-stage disease each
year in the United States alone.
Oncotype SEQ will be performed at Genomic Health's CLIA-certified
laboratory using the company's proprietary cfDNA sequencing
platform.
About Oncotype SEQ™ Liquid Select
Oncotype SEQ Liquid
Select is a blood-based mutation panel that uses next-generation
sequencing to identify and assess 17 genes with well-known
clinically actionable molecular markers that have either been
included in National Comprehensive Cancer Network
(NCCN®) guidelines or associated with sensitivity or
resistance to relevant FDA-approved therapies in cancers of the
lung, breast, colon, skin, ovaries, and gastrointestinal stromal
tumors. The panel is comprehensive, covering all currently approved
actionable drugs and actively enrolling Phase II-IV clinical trials
as options for patients on the basis of their genomic alterations.
For more information, please visit, www.OncotypeSEQ.com.
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 cancer, 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 600,000 cancer patients
worldwide. Genomic Health is expanding its test portfolio
to include additional liquid and tissue-based tests. 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 fact sheet contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. 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: our ability to develop and commercialize new tests
and expand into new markets domestically and internationally; the
risk that we may not obtain or maintain sufficient levels of
reimbursement, domestically or abroad; competition; unanticipated
costs or delays in research and development efforts; the regulation
of our tests; the applicability of clinical study results to actual
outcomes; our business model; our ability to obtain capital when
needed; and the other risks and uncertainties set forth in our
filings with the Securities and Exchange Commission, including the
risks set forth in our Quarterly Report on Form 10-Q for the
quarter ended March 31, 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, Breast 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.
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SOURCE Genomic Health, Inc.