Press news Biocartis Group NV: Biocartis Receives EUR 1.2 million
Grant for Development of Highly Innovative Idylla™ GeneFusion Assay
PRESS RELEASE: 30 September 2020, 07:00 CEST
Biocartis Receives EUR 1.2 million Grant
for Development of Highly Innovative Idylla™ GeneFusion
Assay
Mechelen, Belgium, 30 September
2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’),
an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces that it has received a EUR 1.2 million
grant from VLAIO, the Flanders organization for Innovation &
Entrepreneurship, for the development of the highly innovative
GeneFusion Assay on its easy, rapid molecular and fully automated
diagnostics platform Idylla™.
The Idylla™ GeneFusion Assay will include a
highly multiplexed panel of established and emerging biomarkers,
and will be the first FFPE1 RNA2-based assay on the Idylla™
platform. The Idylla™ GeneFusion Assay is expected to bring results
in approx. 3 hours, with less than 2 minutes hands-on time. The
VLAIO grant is intended to support the development of the
GeneFusion Assay on the Idylla™ platform, and to support related
research studies on different sample and tumor tissue types,
including on lung cancer tissue.
Lung cancer is the most common cause of
cancer-related deaths worldwide (27%) with 1.7 million deaths
annually3. Clinical non-small cell lung cancer (NSCLC) guidelines4
recommend testing for amongst others EGFR mutations5. Today, gene
fusions represent an increasingly important biomarker test
category6. Although detected in a small portion of NSCLCs, testing
for these gene fusions is important for the identification of
patients who may benefit from different fusion gene targeted
therapies, which show high response rates and long disease control
upon treatment7. Current testing methods however are cumbersome
because different technologies8 are needed to test all required
biomarkers. Additionally, sample quantity and quality to perform
all these tests are commonly suboptimal. Due to these complexities,
time to results can be delayed, which can lead to inappropriate
treatment decisions.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “We are very pleased to receive
this VLAIO grant and support from the Flemish government for highly
innovative projects such as our GeneFusion Assay project. In the
area of lung cancer testing, there is a clear unmet diagnostic need
for comprehensive and fast molecular testing solutions that are
compatible with a limited amount of sample. Together with the
existing Idylla™ EGFR Mutation Test (CE-IVD), a key test in our
lung cancer menu, the Idylla™ GeneFusion Assay (RUO9) is expected
to offer our customers-laboratories a comprehensive testing
solution for molecular biomarkers in this area, without the need
for different instruments, and covering the majority of clinical
guideline-recommended biomarkers.”
Biocartis expects to launch its Idylla™ GeneFusion Assay as a
Research Use Only (RUO) assay in Q1 2021. Validation and
release of an IVD version for use in NSCLC is also anticipated.
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More information: Renate
DegraveHead of Corporate Communications & Investor Relations
Biocartise-mail
rdegrave@biocartis.comtel
+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™ 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 is developing and marketing a continuously
expanding test menu addressing key unmet clinical needs, with a
focus in oncology, which represents the fastest growing segment of
the MDx market worldwide. Today, Biocartis offers tests supporting
melanoma, colorectal and lung cancer. More
information: www.biocartis.com. Follow us on Twitter:
@Biocartis_.
Biocartis and Idylla™ are registered trademarks
in Europe, the United States and other countries. The Biocartis and
Idylla™ trademark and logo are used trademarks owned by Biocartis.
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1 Formalin fixed, paraffin embedded
2 Rubonucleic Acid. RNA is one of the three major biological
macromolecules that are essential for all known forms of life
(along with DNA and proteins)
3 Despite advances in early detection and treatment, most
patients are diagnosed at an advanced stage and have a poor
prognosis, with an overall 5-year survival rate of approx. 15%.
Source: Kim E.S., Roy U.B., Ersek J.L., King J., Smith R.A., Martin
N., Martins R., Moore A., Silvestri G.A., Jett J., 2019, Updates
regarding biomarker testing for non-small cell lung cancer:
considerations from the National Lung Cancer Roundtable
4 CAP/IASLC/AMP: College of American Pathologists/ International
Association for the study of lung cancer/ Association for Molecular
Pathology
5 And for ALK fusions, ROS1 fusions and BRAF mutations
6 One of the best-characterized examples is the fusion of EML4
and ALK genes, which is also the most prevalent fusion occurring in
about 5% of NSCLCs
7 Villalobos P., Wistuba I.I, 2018, Lung cancer biomarkers. See
also
https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/targeted-therapies.html,
last consulted on 24 September 2020. Peters et al, N Engl J Med
2017 377:829-838; Hong et al, Lancet Oncol 2020 21(4):531-540;
Drilon et al N Engl J Med 2020; 383:813-824
8 Techniques used to detect NTRK gene fusions include DNA-based
next-generation sequencing (NGS), RNA-based NGS,
reverse-transcriptase PCR (RT-PCR), fluorescence in situ
hybridisation (FISH), and immunohistochemistry (IHC). Source:
OncologyPro, ESMO, see here, last consulted on 23 September
2020
9 Not for use in diagnostic procedures
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