Biocartis receives grant for development of a fully automated MSI test

Biocartis receives grant for development of a fully automated MSI test

ID: 530205

(Thomson Reuters ONE) -



PRESS RELEASE: 15 March 2017, 07:00 CET

Biocartis receives grant for development of a fully automated MSI test
Test could be validated as prognostic test for colorectal cancer and predictive
test for cancer immunotherapies

Mechelen, Belgium, 15 March 2017 - Biocartis Group NV ('the Company' or
'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announced it has received an approximately EUR 750k grant from
VLAIO, the Flanders organization for Innovation & Entrepreneurship[1]. The grant
supports Biocartis' ongoing microsatellite instability (MSI) and mutational load
research program in collaboration with Prof. Diether Lambrechts (VIB - KU Leuven
Center for Cancer Biology, Belgium), and aims to support the development of a
fully automated MSI test on the Company's Idylla(TM) platform. The test will be
based on a set of novel MSI markers[2] identified by Prof. Diether Lambrechts'
laboratory, which were exclusively licensed to Biocartis from VIB in 2013.

MSI testing today: manual, lengthy and complex
Microsatellite instability is the result of errors in the body's so-called DNA
mismatch repair (MMR) system. Consequently, errors that normally spontaneously
occur during DNA replication are no longer corrected, resulting potentially in
tumor growth. Today's commonly used techniques for MSI testing are expensive and
rely on manual, lengthy and complex procedures involving amongst others PCR
analysis followed by capillary electrophoresis using the Bethesda marker
panel[3]. Because of these drawbacks, the potential of MSI testing is heavily
underutilized. The novel MSI markers from VIB show 98.7% concordance with
available MSI tests[4]. Furthermore, these markers enable testing based on




Polymerase Chain Reaction (PCR) analysis only, and as such can be fully
automated on Biocartis' Idylla(TM) platform.

Prognostic test for colorectal cancer
Today, MSI testing is included in several guidelines[5] for all colorectal
cancers (CRC) as CRC patients with an MSI-high status show a better prognosis
compared to other CRC patients, and should consequently receive a different
treatment (e.g. not to be given certain adjuvant chemotherapies(3)). The
Idylla(TM) MSI Test under development will operate directly on a single slice of
FFPE[6] tissue from human CRC tissue. This without the need for a second slice
used for control, as required for Bethesda method based testing. Thanks to this
grant, Biocartis will be able to develop an easy, rapid and highly accurate
standardized MSI test, available to a much larger patient population.

Prof. Diether Lambrechts, Director of the VIB - KU Leuven Center for Cancer
Biology, commented: "MSI testing can offer high clinical value to oncology
treatments. The biomarkers that we identified at VIB in combination with the
advantages of the Idylla(TM) platform would allow us to significantly lower
barriers for MSI testing. We are excited to extend our collaboration with
Biocartis into the immunotherapy space."

Predictive test for cancer immunotherapies
Recent data[7] have shown that advanced CRC patients with an MSI-high status
respond particularly well to certain immunotherapies. As such, MSI may not only
represent a prognostic marker, but may also predict a patient's response to
certain immunotherapies which have demonstrated a positive impact on long term
survival, especially in combination with targeted cancer therapies. Therefore,
Biocartis will also collaborate with VIB to investigate MSI signatures in
cancers other than CRC, the predictive nature of MSI markers for immunotherapy
response, and mutational load signatures related to cancer immunotherapies.

Geert Maertens, Chief Scientific Officer of Biocartis, added: "With Idylla(TM),
MSI testing has the potential to open up to many more CRC patients with the aim
to positively impact patient prognosis and patient management. Furthermore, this
grant will also support the road to a highly innovative MSI test for cancer
immunotherapy, which we know will be of great value for the pharmaceutical
industry. We are very grateful for this VLAIO project grant and look forward to
continue to collaborate with Prof. Diether Lambrechts and his team."

Biocartis aims to launch its Idylla(TM) MSI Test in 2018.

--- END ---
More information:
Renate Degrave
Manager Corporate Communications & Investor Relations
e-mail   rdegrave(at)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 eight oncology tests and two
infectious disease tests. More information: www.biocartis.com. Press Photo
Library available here. Follow us on Twitter: (at)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.


--------------------------------------------------------------------------------

[1] Formerly known as IWT.
[2] Zhao et al. (2014) eLife 3:e02725, 1-26.
[3] The Bethesda MSI reference panel, established in 1997, consists of two
mononucleotide loci (Big Adenine Tract or BAT-25 and BAT-26) and three
dinucleotide loci (D2S123, D5S346 and D17S250). Using the Bethesda panel,
cancers with instability at 2 or more of these loci were interpreted as MSI-
high, and cancers with no instability at any of the five loci were considered
Microsatellite Stable (MSS).
[4] Claes et al. ASCO 2015.
[5] NCCN Guidelines Colon Cancer version 2017.1; and, Van Cutsem et al. (2016)
ESMO Consensus Guidelines for the management of patients with mCRC. Annals of
Oncology 27, 1386-1422.
[6] Formalin-fixed, paraffin-embedded.
[7] Xiao Y et al. (2015) The microsatellite instable subset of colorectal cancer
is a particularly good candidate for checkpoint blockade immunotherapy. Cancer
Discov. 5, 16-18; and, Le et al. (2015) PD-1 Blockade in Tumors with Mismatch-
Repair Deficiency. N Engl J Med 372, 2509-2520.



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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Datum: 15.03.2017 - 07:00 Uhr
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News-ID 530205
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