Bli medlem
Bli medlem

Du är här


Biocartis Group NV: CE-marking Idylla(TM) NRAS-BRAF Mutation Test completes offering of metastatic colorectal cancer tests for clinical use on Idylla(TM) platfo

PRESS RELEASE: 15 December 2016, 07:00 CET

CE-marking Idylla(TM) NRAS-BRAF Mutation Test completes offering
of metastatic colorectal cancer tests for clinical use on Idylla(TM) platform

Mechelen, Belgium, 15 December 2016
- Biocartis Group NV ('Biocartis'), an innovative molecular diagnostics
company (Euronext Brussels: BCART), today announces the CE-marking of its
solid biopsy Idylla(TM) NRAS-BRAF Mutation Test. Together with the CE-marked
Idylla(TM) KRAS Mutation Test, Biocartis is now able to offer its customers a
complete testing for metastatic colorectal cancers[1](mCRC) for clinical use
on its Idylla(TM) molecular diagnostics platform, as recommended by the most
recent clinical guidelines. The ability of Biocartis' RAS test offering to
enable same-day results can now open routes towards faster treatment
selection for mCRC patients.

Colorectal cancer is the second most common cancer worldwide, with an
estimated incidence of more than 1.36 million new cases annually[2].
Operating directly from so-called formalin-fixed paraffin embedded (FFPE)
tumour slices, the fully automated Idylla(TM) NRAS-BRAF Mutation Test
uniquely combines, in a single-tissue biopsy test, the detection of 18 NRAS
and 5 BRAF mutations at high sensitivity. This follows the latest clinical
practice recommendations of the American Society of Clinical Oncology
(ASCO)[3]and the European Society for Medical Oncology (ESMO)[4]which, next
to KRAS and NRAS testing, now also recommend testing on BRAF mutations as
most frequently occurring mutations in colorectal cancer.

Together with its existing Idylla(TM) KRAS Mutation Test that detects 21
mutations, the Biocartis colorectal cancer test offering now allows
simultaneous detection of 44 so-called clinically actionable targets for
colorectal cancer. The obtained CE-marking of the Idylla(TM) NRAS-BRAF
Mutation Test is an important driver in the further market adoption of

Rudi Pauwels, Chief Executive Officer of Biocartis
: "Many of our European customers as well as our distribution partners have
awaiting the CE-mark of our Idylla(TM) NRAS-BRAF Mutation Test. Together
with our existing CE-marked Idylla(TM) KRAS Mutation Test for colorectal
cancer, which was recently rewarded in a study
[5]by the global pharmaceutical company AstraZeneca as being the fastest, most
easy to use and one of the most accurate high precision tests compared to
peers, Biocartis now has a full CE-marked colorectal cancer mutations test
panel. This panel allows for complete same-day testing and treatment
selection for mCRC patients.
As such, we expect this CE-marking to add substantial traction to our
commercial cartridge consumption."

The Idylla(TM) NRAS-BRAF Mutation Test is the fourth CE-marked IVD test for
Biocartis in its offering of easy-to-use, rapid and highly accurate
diagnostic tests for the Idylla(TM) molecular diagnostics platform.

--- END ---

More information:

Renate Degrave
Manager Corporate Communications&Investor Relations

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: Photo Library availablehere. Follow us onTwitter:

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.
[1]Jean-Yves Douillard, M.D., Ph.D., Kelly S. Oliner, Ph.D., Salvatore Siena,
M.D., et al. Panitumumab-FOLFOX4 Treatment and RAS Mutations in Colorectal
Cancer. N Engl J Med 2013;369:1023-34
[2]Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M,
Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and
Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France:
International Agency for Research on Cancer; 2013. Available
at: Last accessed November 2016.
[3]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, See also
[4]Van Cutsem et al, ESMO consensus guidelines for the management of patients
with metastatic colorectal cancer, Annals of Oncology 2016, 8:1386-1422.
[5]James L. Sherwoord, 2016, Implications of Key Differences Across 12
KRAS Mutation Detection Technologies and Their Relevance in Clinical
Practice, first presented at ESMO, 10 October 2016, available for download

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

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.