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2016-02-03

Biocartis Group NV: Biocartis and Amgen Collaborate to Offer Rapid RAS Biomarker Testing to Selected Hospitals and Clinics in Brazil, Canada, Colombia, Mexico,

* Biocartis and Amgen have entered into a collaboration to evaluate
Idylla(TM) RAS testing as tool for rapid decentralized testing in Brazil,
Canada, Colombia, Mexico, Saudi Arabia, Spain, and Turkey
* Assessment of RAS (KRAS/NRAS) biomarker status is important in treatment
selection for patients with metastatic colorectal cancer
* With the Idylla(TM) system, RAS testing can be accelerated from several
weeks to same-day results
* The collaboration underlines Amgen's and Biocartis' commitment to patients
in oncology in offering high precision medicine and high precision
diagnostics

Mechelen, Belgium, February 3, 2016
- Biocartis today announced that it has entered into collaboration with Amgen,
a leading biotechnology company, to offer its new RAS biomarker tests to
hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and
Turkey. The aim of the collaboration is to accelerate access to RAS biomarker
information in the selected countries.

For patients with metastatic colorectal cancer (mCRC), timely information on
the presence of mutations in the RAS genes (KRAS and NRAS) is critical in
treatment selection. Technologies to assess RAS gene mutational status,
currently used by hospitals across the globe, are complex to perform and on
average, require several weeks to provide results. In certain countries,
local RAS testing is unavailable and samples have to be sent abroad for
testing, which further delays availability of results and consequently,
treatment selection for patients. With the Biocartis Idylla(TM) system, RAS
biomarker testing can be performed locally and in a significantly shorter
timeframe.

The Idylla(TM) KRAS Mutation Test and Idylla(TM) NRAS-BRAF-EGFR S492R Mutation
Assay together provide for a complete mCRC mutation analysis[1]from two
slices of so-called formalin-fixed paraffin embedded (FFPE) tumor tissue.
With a turn-around-time of around two hours and each test requiring less than
two minutes of hands-on time, the Idylla(TM) system can be operated in any
hospital laboratory, independent of hospital size, available infrastructure
and experience level. For the first time in the molecular pathology field,
the Idylla(TM) test allows performance of a complete RAS analysis on a
same-day basis, opening up the route towards faster treatment selection.

Under the current collaboration, Amgen will make Idylla(TM) RAS testing
available to several reference hospitals in Brazil, Canada, Colombia, Mexico,
Saudi Arabia, Spain and Turkey.

Ulrik Cordes, Chief Commercial Officer Biocartis
,commented
: "We are very pleased to work with Amgen to accelerate the roll-out of our
state-of-the-art Idylla(TM)extended RAS testing solutions in hospitals
worldwide. We view the fact that leading biopharmaceutical companies are
electing to utilize our recently launched Idylla(TM) solutions, to improve
access to advanced high precision diagnostic testing, as a confirmation of
the quality of our products. Our collaboration will significantly enable
improved patient care in countries where cancer patients, until now, have had
to wait weeks, and sometimes months, to get critical diagnostic information.
Together with Amgen, we can now secure much faster access to the right
treatment for certain patients, thereby reducing anxiety for the affected
patients and their relatives.
"

Amgen has played a significant role in the advancement of personalized
medicine, applying cutting-edge science and technology in its efforts to
target therapies to the patients who are most likely to benefit.

Using molecular approaches to identify unique, genetic signatures in mCRC has
the potential to help improve treatment outcomes. Of the few biomarkers in
colorectal cancer, RAS genes (KRAS, NRAS) have a validated impact on
treatment outcomes.

Biocartis' mission is to become a leading player in the molecular diagnostics
space by providing innovative high precision diagnostic solutions that allow
instant, global access to accurate, 'first time right' molecular information
from any biological sample. Thereto, the company is continuing to develop a
range of molecular tests for oncology and infectious diseases to enable fast
and effective diagnosis, treatment selection and treatment progress
monitoring. The current collaboration with Amgen underlines Biocartis'
commitment to make its solutions available to patients across the globe.

----- END ----

For more information:

Biocartis

Renate Degrave (Corporate Communications&Investor Relations)
+32 15 632 600 |press@biocartis.com
About colorectal cancerColorectal cancer is the third most common cancer worldwide, with
approximately 1.2 million cases occurring globally each
year.[2],[3]Approximately 20 percent of colon cancers are diagnosed at the
metastatic stage, when the disease has already spread to distant organs, a
diagnosis associated with only a 12 percent five-year survival rate. Using
molecular approaches to identify unique genetic signatures in mCRC has the
potential to help improve treatment outcomes. Of the few biomarkers in
colorectal cancer, RAS genes (KRAS, NRAS) have a validated impact on
treatment outcomes.[2],[3]

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. Idylla(TM) addresses the
growing demand for personalized medicine by aiming to allow fast and
effective treatment selection and treatment progress monitoring.

Biocartis launched the Idylla(TM) platform commercially in September 2014
together with its first assay to identify BRAF mutations in metastatic
melanoma. In June 2015, the Idylla(TM) KRAS Mutation Test for colorectal
cancer was launched, followed by the first infectious disease assay in
November 2015, the Idylla(TM) Respiratory (IFV-RSV) Panel, developed in
collaboration with Janssen Diagnostics. In December 2015, Biocartis launched
its Idylla(TM) NRAS-BRAF-EGFR S492R Mutation Assay as a Research Use Only
(RUO). 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. Further information can be found
atwww.biocartis.com.

References

[1]Combined, the two Idylla(TM) RAS tests allow for detection of 39 different
clinically actionable KRAS and NRAS mutations at high sensitivity in line
with the novel clinical guidelines as recently issued by the European Society
for Medical Oncology, American Society of Clinical Oncology, the Association
for Molecular Pathology and the National Cancer Institute.
[2]Fight Colorectal Cancer. Biomarker Testing for Colorectal Cancer: Common
Biomarker Tests for Colon Cancer. Accessed on Feb 1, 2016: available
at:http://fightcolorectalcancer.org/fightcrc-fightit/biomarker-testing-for-....
[3]Colon Cancer Alliance. Get Information: Treatment: Biomarkers. Know Your
Biomarker. Accessed on Feb.1, 2016: available
at:http://www.ccalliance.org/get-information/treatment/biomarkers/.

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX 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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