REDWOOD CITY, Calif. and
MECHELEN, Belgium, Sept. 13, 2017 /PRNewswire/ -- Genomic
Health, Inc. (NASDAQ: GHDX), the world's leading provider of
genomic-based diagnostic tests and Biocartis Group NV
(Euronext Brussels: BCART), an innovative molecular diagnostics
company, today announced an exclusive agreement to develop an in
vitro diagnostic (IVD) version of the Oncotype DX Breast Recurrence
Score® test on Biocartis' Idylla™ platform that can be
performed locally by laboratory partners and in hospitals around
the world.
The Oncotype DX Breast Recurrence Score test examines the
activity of 21 genes in a patient's breast tumor tissue to provide
personalized information for tailoring treatment based on the
biology of their individual disease. As the only test proven to
predict chemotherapy benefit, the Oncotype DX Breast Recurrence
Score test is included in all major cancer guidelines worldwide and
is now considered standard of care for early-stage breast
cancer.
Biocartis' proprietary Idylla™ platform offers a unique solution
that is currently unmatched in the localization of complex
molecular diagnostics. With the fully automated sample-to-answer,
real-time polymerase chain reaction (PCR) -based cartridge of the
Idylla platform, Genomic Health intends to enable local pathology
labs to generate Oncotype DX Breast Recurrence Score results with
minimal labor, efficient turnaround time, and the consistent high
quality and clinical utility that physicians and patients have come
to expect when making treatment decisions with Oncotype DX.
"We are excited to augment our successful U.S. centralized
laboratory business model with an IVD system that can be
implemented by local laboratories to increase global patient access
to standard of care testing with the Oncotype DX Breast Recurrence
Score test planned for launch in Europe, beginning with France and Germany, in 2019," said Frederic Pla, Ph.D., chief business and product
development officer, Genomic Health. "We believe our strategic
collaboration with Biocartis positions us to accelerate adoption
and market access around the world, as well as to broaden
partnership opportunities with pharmaceutical companies seeking
diagnostic solutions with the ability to develop and offer tests
globally through decentralized settings."
Herman Verrelst, chief executive officer of Biocartis,
commented: "Adding world-leading assays such as the Oncotype
DX test to our Idylla platform is an essential step in our strategy
to rapidly expand the menu offering on our platform. Today's
announcement demonstrates how we can assist providers of
proprietary molecular tests in making their offering available to
local labs across the globe, without the need for a highly
specialized molecular diagnostics infrastructure. This demonstrates
the true strength and ambition of the Idylla technology: enabling
the best molecular diagnostics for all patients, worldwide. We are
impressed by what Genomic Health has realized so far, and our team
looks forward to making this strategic collaboration a
success."
The strategic collaboration will provide Genomic Health with
exclusive worldwide rights to develop and commercialize its
Oncotype DX Breast Recurrence Score test on the Idylla platform,
with the option to expand the collaboration to include additional
tests in oncology and urology. Development of the Oncotype
DX® IVD test is expected to begin in late 2017, with the
aim of providing initial access to patients in Europe, beginning with France and Germany, in 2019.
As part of the agreement, Genomic Health will make a payment of
approximately $3.3 million to
Biocartis, which is expected to be expensed in the third quarter of
2017. Additional payments to Biocartis will be made as certain
developmental and commercial milestones are achieved in the future.
Genomic Health continues to expect to be profitable for the full
year 2017, excluding these transaction costs. Upon
commercialization, Genomic Health will make royalty payments to
Biocartis based on net sales of the IVD tests developed on the
Biocartis Idylla platform.
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 800,000 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.
About Biocartis
Biocartis (Euronext Brussels:
BCART) is an innovative molecular diagnostics (MDx) company
providing next generation diagnostic solutions aimed at improving
clinical practice for the benefit of patients, clinicians, payers
and industry. Biocartis' proprietary MDx Idylla™ platform is a
fully automated sample-to-result, real-time PCR (Polymerase Chain
Reaction) system that offers accurate, highly reliable molecular
information from virtually any biological sample in virtually any
setting. Biocartis launched the Idylla™ platform in September 2014. Biocartis is developing and
marketing a rapidly expanding test menu addressing key unmet
clinical needs in oncology and infectious diseases. These areas
represent respectively the fastest growing and largest segments of
the MDx market worldwide. Today, Biocartis offers ten oncology
tests and two infectious disease tests in Europe. More
information: www.biocartis.com. Press Photo Library available
here. Follow us on Twitter: @Biocartis_.
Genomic Health Forward-Looking Statements
This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to Genomic Health's beliefs regarding
its future performance, including its guidance of
profitability for the full year 2017 and the factors that may
impact such guidance; the company's ability to successfully develop
and commercialize an IVD test; the expected benefits of an IVD
version of the company's breast cancer test, and its expectations
regarding timing and geographic rollout of any such test; the
company's belief that the collaboration will allow it to accelerate
adoption, reimbursement and access to the test and broaden other
partnership opportunities; the commercial performance of its tests;
the attributes and focus of the company's product pipeline; the
ability of any potential tests the company may develop to optimize
cancer treatment; and the ability of the company to develop and
commercialize, and collaborate with third parties to 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 Genomic Health's
ability to execute its business model; the regulation of Genomic
Health's tests or any tests offered through its commercial channel;
the applicability of clinical study results to actual outcomes;
Genomic Health's ability to develop, commercialize or collaborate
to offer any new test, including an IVD version of its breast
cancer test, in new markets domestically and internationally; the
risk that sufficient levels of reimbursement may not be obtained or
maintained, domestically or abroad, for Genomic Health's tests or
tests offered through its commercial channel; competition;
unanticipated costs or delays in research and development efforts;
Genomic Health's ability or the ability of its collaborators to
obtain capital when needed to support the activities contemplated
by the collaboration described in this press release; and the other
risks and uncertainties set forth in Genomic Health's filings with
the Securities and Exchange Commission, including the risks set
forth in Genomic Health's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2017. These
forward-looking statements speak only as of the date hereof.
Genomic Health disclaims any obligation to update these
forward-looking statements.
Biocartis Forward-Looking Statements
Certain
statements, beliefs and opinions in this press release are
forward-looking, which reflect Biocartis' or, as appropriate, the
Biocartis directors' or managements' current expectations and
projections concerning future events such as the Biocartis' results
of operations, financial condition, liquidity, performance,
prospects, growth, strategies and the industry in which the
Biocartis operates. By their nature, forward-looking statements
involve a number of risks, uncertainties, assumptions and other
factors that could cause actual results or events to differ
materially from those expressed or implied by the forward-looking
statements. These risks, uncertainties, assumptions and factors
could adversely affect the outcome and financial effects of the
plans and events described herein. A multitude of factors
including, but not limited to, changes in demand, competition and
technology, can cause actual events, performance or results to
differ significantly from any anticipated development.
Forward-looking statements contained in this press release
regarding past trends or activities are not guarantees of future
performance and should not be taken as a representation that such
trends or activities will continue in the future. In addition, even
if actual results or developments are consistent with the
forward-looking statements contained in this press release, those
results or developments may not be indicative of results or
developments in future periods. As a result, the Biocartis
expressly disclaims any obligation or undertaking to release any
updates or revisions to any forward-looking statements in this
press release as a result of any change in expectations or any
change in events, conditions, assumptions or circumstances on which
these forward-looking statements are based. Neither the Biocartis
nor its advisers or representatives nor any of its subsidiary
undertakings or any such person's officers or employees guarantees
that the assumptions underlying such forward-looking statements are
free from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
press release or the actual occurrence of the forecasted
developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX,
Oncotype DX Breast Recurrence Score, Oncotype IQ and Oncotype SEQ
are trademarks or registered trademarks of Genomic Health,
Inc.
The Biocartis trademark and logo are trademarks of Biocartis
and are used and registered in Europe. Idylla™ is a registered trademark in
the United States and other
countries. The Idylla™ trademark and logo are trademarks of and
used by Biocartis. This press release is not for distribution,
directly or indirectly, in any jurisdiction where to do so would be
unlawful. Any persons reading this press release should inform
themselves of and observe any such restrictions. Biocartis takes no
responsibility for any violation of any such restrictions by any
person. Please refer to the product labeling for applicable
intended uses for each individual Biocartis product. This press
release does not constitute an offer or invitation for the sale or
purchase of securities in any jurisdiction. No securities of
Biocartis may be offered or sold in the
United States of America absent registration with the United
States Securities and Exchange Commission or an exemption from
registration under the U.S. Securities Act of 1933, as
amended.
GHDX-F
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SOURCE Genomic Health, Inc.