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2016-12-22

Biocartis Group NV: Biocartis and Amgen sign a RAS Biomarker Testing Collaboration in Europe

PRESS RELEASE: 22 December 2016, 07:00 CET

REGULATED INFORMATION - INSIDE INFORMATION

Biocartis and Amgen sign a RAS Biomarker Testing Collaboration in Europe

Mechelen, Belgium, 22 December 2016
- Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics
company (Euronext Brussels: BCART), today announced the signing of a new
collaboration agreement with Amgen, a leading biotechnology company. The new
agreement, which builds on the existing collaboration between both companies
announced on 3 February 2016[1], aims at accelerating access to RAS biomarker
information in up to 10 European countries.

For metastatic colorectal cancer (mCRC) patients, timely information on the
presence of mutations in the RAS genes (KRAS, NRAS) and BRAF[2]is critical
for treatment selection. Current technologies to assess RAS gene mutational
status used by hospitals are complex to perform and on average, require up to
one month to provide results. In certain countries, RAS testing samples have
to be sent abroad, which further delays results and treatment selection for
patients.

Based on the experience from the existing collaboration, Biocartis and Amgen
will now aim to enable several dozen additional selected hospitals in Europe
to accelerate access to RAS biomarker information, from up to one month to
same-day results for mCRC patients, using Biocartis' Idylla(TM) platform and
RAS tests.

Biocartis' CE-marked RAS mutations test offering has a turn-around-time of
only two hours with less than two minutes hands-on time. Furthermore, the
Idylla(TM) platform can be operated in any hospital laboratory, independent
of hospital size, available infrastructure and experience level.

Ulrik Cordes, EVP Pharma Collaborations and Companion Diagnostics
,commented
: "We are very pleased to have expanded our agreement with Amgen. This strong
partnership will help to further boost the footprint of Idylla(TM) systems in
Europe. Additionally, it is another step towards our ultimate goal of
improving patient access to rapid and reliable biomarker information with the
potential to enable more rapid treatment selection."

The expansion of Biocartis' agreement with Amgen is part of Biocartis' active
partnership strategy for its Idylla(TM) platform, aimed at enabling
personalized medicine for patients across the globe through rapid, highly
accurate and easy to use high precision diagnostic solutions. The
collaboration also includes the possibility to use the Idylla(TM) platform in
scientific studies to further understand the role of biomarkers in clinical
practice.

--- END ---

More information:

Renate Degrave
Manager Corporate Communications&Investor Relations
e-mail rdegrave@biocartis.com

tel +32 15 631 729
mobile +32 471 53 60 64

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 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 six oncology tests and two infectious disease tests. More information:
www.biocartis.com.Press Photo Library availablehere. Follow us onTwitter:
@Biocartis_.

Certain statements, beliefs and opinions in this press release are
forward-looking, which reflect the Company or, as appropriate, the Company
directors' current expectations and projections concerning future events such
as the Company's results of operations, financial condition, liquidity,
performance, prospects, growth, strategies and the industry in which the
Company 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 Company expressly disclaims any obligation or undertaking to release any
update 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 Company 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.
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[1]The collaboration announced on 3 February 2016 focused on selected
reference hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain
and Turkey.
[2]Following the latest clinical practice recommendations of the American
Society of Clinical Oncology (ASCO) and the European Society for Medical
Oncology (ESMO). ASCO: Allegra et al, Extended RAS Gene Mutation Testing in
Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth
Factor Receptor Monoclonal Antibody Therapy: American Society of Clinical
Oncology Provisional Clinical Opinion Update 2015, J Clin Oncol 2016,
34:179-185, http://ascopubs.org/doi/pdf/10.1200/jco.2015.63.9674. See also
http://gicasym.org/asco-updates-guideline-include-testing-new-ras-mutations.
ESMO: Van Cutsem et al, ESMO consensus guidelines for the management of
patients with metastatic colorectal cancer, Annals of Oncology 2016,
8:1386-1422.

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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

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