Press release Biocartis Group NV: Biocartis Announces the Launch of the First Assay Developed With the New Idylla™ Flex Technology
09 Februar 2023 - 7:00AM
Press release Biocartis Group NV: Biocartis Announces the Launch of
the First Assay Developed With the New Idylla™ Flex Technology
PRESS RELEASE
9 February 2023, 07:00 CET
BIOCARTIS
ANNOUNCES THE LAUNCH OF THE FIRST
ASSAY DEVELOPED WITH THE NEW
IDYLLA™ FLEX
TECHNOLOGY
Mechelen,
Belgium, 9 February 2023
– Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative
molecular diagnostics company (Euronext Brussels: BCART), today
announces the launch of the Idylla™ IDH1-2 Mutation Assay Kit
(RUO)1 among selected customers. The assay is the first test
developed with the new Idylla™ FLEX technology that separates the
generic components of an Idylla™ test from the test-specific
components. The Idylla™ IDH1-2 Mutation Assay Kit (RUO) will become
globally available to customers during the second half of 2023.
The Idylla™ FLEX technology shortens the
development time of new Idylla™ assays, allowing to bring them to
the market much faster. The technology combines a generic Idylla™
cartridge, which can be mass-manufactured on Biocartis’
high-throughput manufacturing line at low cost, with the
test-specific components that are provided in a separate vial of
which the content can be added into the generic Idylla™ cartridge
by the user together with the sample. The Idylla™ FLEX technology
will first be deployed for tests that use FFPE2, peripheral blood
mononuclear cells, bone marrow mononuclear cells, whole blood or
extracted DNA as sample type. In a next step, it is intended to be
deployed for tests that can use up to 4 ml of plasma as sample
type.
In a next phase, the off-line customization of
the Idylla™ cartridge could be deployed in the rapidly growing
field of molecular surveillance, where patients are monitored with
molecular tests. The Idylla™ FLEX technology is ideally suited for
both tumor-informed (aka bespoke or personalized) as well as
tumor-naïve panels, both of which have shown promise for molecular
surveillance. Moreover, Idylla™ FLEX will be a major steppingstone
to testing liquid biopsy samples, which is expected to account for
the largest share within the vast market opportunity of molecular
surveillance monitoring.
The Idylla™ IDH1-2 Mutation Assay Kit (RUO) is
the first test developed using the Idylla™ FLEX technology.
Mutations in the isocitrate dehydrogenase 1 (IDH1) and 2 (IDH2)
genes are oncogenic drivers that are frequently found in a variety
of human malignancies, including gliomas, acute myeloid leukemia,
cholangiocarcinoma, chondrosarcoma and thyroid carcinoma3. The
Idylla™ IDH1-2 Mutation Assay Kit (RUO) can detect 5 mutations in
IDH1 and 10 mutations in IDH2, along with an integrated processing
control. The turn-around-time is less than 2 hours from sample to
result. The assay performance has been evaluated at multiple sites
in both US and Europe. The assay will be further deployed across
the Biocartis customer base and will also be made available for
partnerships with pharmaceutical companies, clinical research
organizations and reference labs conducting research.
Herman Verrelst, Chief Executive Officer
of Biocartis, said: “We
already had a broad menu of tests in oncology, which we now expand
with a rapid test for the detection of mutations in IDH1 and IDH2.
This new test was highly requested throughout our customer base,
especially in the US. The successful development of this first
assay using the Idylla™ FLEX technology is a major achievement and
will allow us to expand our menu of tests on Idylla™ much faster
and tap into the growing field of liquid biopsy-based monitoring.”
Benoit Devogelaere, Chief Technology Officer of Biocartis,
further complemented: “The new Idylla™ FLEX technology has
the potential to be deployed across the entire spectrum of research
in molecular surveillance, including treatment response monitoring,
Molecular Residual Disease (MRD)4 and recurrence monitoring. Now
that cancer treatment becomes increasingly personalized, we see
multiple fields of application for the customization and even
personalization offered by the Idylla™ FLEX technology, in
particular for the frequent and repeated liquid biopsy-based
testing of patients.”
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More information:
e-mail: ir@biocartis.com
@Biocartis_
www.linkedin.com/Biocartis
About Biocartis
With its revolutionary and proprietary Idylla™
platform, Biocartis (Euronext Brussels: BCART) aspires to enable
personalized medicine for patients around the world through
universal access to molecular testing, by making molecular testing
actionable, convenient, fast and suitable for any lab. The Idylla™
platform is a fully automated sample-to-result, real-time PCR
(Polymerase Chain Reaction) based system designed to offer in-house
access to accurate molecular information in a minimum amount of
time for faster, informed treatment decisions. Idylla™'s
continuously expanding menu of molecular diagnostic tests address
key unmet clinical needs, with a focus in oncology. This is the
fastest growing segment of the molecular diagnostics market
worldwide. Today, Biocartis offers tests supporting melanoma,
colorectal, lung and liver cancer, as well as for COVID-19, Flu,
RSV and sepsis. For more information, visit www.biocartis.com
or follow Biocartis on Twitter @Biocartis_ , Facebook or
LinkedIn. 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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as appropriate, the Company directors' or managements' current
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1 Research Use Only2 Formalin fixed, paraffin embedded tissues
are samples, typically from suspected tumors, that are fixed or
mixed with formalin to preserve the structural integrity of the
sample. The sample is then embedded into a type of paraffin wax so
that it can be sliced very thinly3 Han et al. 2020, IDH mutation in
glioma: molecular mechanisms and potential therapeutic targets,
British Journal of Cancer4 Molecular Residual Disease is a small
number of cancer cells left in the body after treatment. These
cells have the potential to cause relapse in patients
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