Biocartis Group NV: Genomic Health and Biocartis Announce Agreement to Develop an Idylla(TM) IVD Oncotype DX® Breast Cancer Test to Broaden Global Patient Access
(Thomson Reuters ONE) -
PRESS RELEASE: REGULATED - INSIDE INFORMATION
Wednesday September 13, 2017, 07:00 CEST
Tuesday September 12, 2017, 22:00 PT
Genomic Health and Biocartis Announce Agreement to Develop an Idylla(TM) IVD
Oncotype DX(®) Breast Cancer Test to Broaden Global Patient Access
Strategic Collaboration Aimed at Exclusive Test Development and
Commercialization of Proprietary Genomic Health Tests on the Idylla(TM) Platform
REDWOOD CITY, Calif., United States, and MECHELEN, Belgium, September 13, 2017
-- Genomic Health, Inc., the world's leading provider of genomic-based
diagnostic tests (NASDAQ: GHDX) and Biocartis Group NV, an innovative molecular
diagnostics company (Euronext Brussels: BCART), today announced an exclusive
agreement to develop an IVD version of the Oncotype DX Breast Recurrence
Score(®) test on Biocartis' Idylla(TM) 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(TM) 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 PCR[1]-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(TM) 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(TM) 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 Biocartis' Idylla(TM)
platform.
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Biocartis Contact:
Renate Degrave
Manager Corporate Communications & Investor Relations Biocartis
Email rdegrave(at)biocartis.com
Tel +32 15 631 729 | mobile +32 471 53 60 64
(at)Biocartis_| www.linkedin.com/Biocartis
Genomic Health Contact:
Emily Faucette
Vice President Corporate Communications & Investor Relations, Genomic Health
Email EFaucette(at)genomichealth.com
Tel +1 650 569 2824
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(TM) 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(TM) platform end 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: (at)Biocartis_.
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(TM) 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: (at)GenomicHealth, Facebook, YouTube and LinkedIn.
Biocartis Forward-Looking Statements
Certain statements, beliefs and opinions in this press release are forward-
looking, which reflect Biocartis' or, as appropriate, Biocartis' directors' or
managements' current expectations and projections concerning future events such
as Biocartis' results of operations, financial condition, liquidity,
performance, prospects, growth, strategies and the industry in which 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, 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 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.
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.
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(TM) is a
registered trademark in the United States and other countries. The Idylla(TM)
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.
--------------------------------------------------------------------------------
[1] Polymerase Chain Reaction
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 13.09.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 559688
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contact information:
Town:
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