PRESS RELEASE: 31 October 2022, 17:40 CET
Biocartis Announces Nine Idylla™ Studies
to be Published at Upcoming AMP 2022 Annual
Meeting
Mechelen, Belgium, 31
October 2022 – Biocartis
Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular
diagnostics company (Euronext Brussels: BCART), today announces the
publication of nine performance study abstracts of its fully
automated molecular diagnostics Idylla™ platform1 and assays2 at
the annual meeting of the ‘Association for Molecular Pathology’
(AMP), a leading molecular diagnostics conference, taking place
between 1-5 November in Phoenix, Arizona (US). The studies were
performed by a variety of US laboratories and research
institutes.
Among the studies published, four studies on the
Idylla™ GeneFusion Assay2 highlighted the strengths of Idylla™
testing including high accuracy, ease-of-use and rapid
time-to-results. Furthermore, one study performed with the new
SeptiCyte RAPID® EDTA3 blood compatible cartridges4 (CE-IVD, not
510(k) cleared) on the Idylla™ platform, developed in collaboration
with Immunexpress, concluded that the addition of the widely used
EDTA blood tube as a validated sample type has the potential to
greatly enhance the clinical utility of this new near-patient
sepsis diagnostic.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “These studies are great,
especially the data published on the Idylla™ GeneFusion Assay which
shows the benefit of Idylla™ biomarker testing versus testing on
more complex and hence slower technologies such as Next Generation
Sequencing, often used very early on in the biomarker testing
process. With Idylla™, the time-to-result of diagnostic testing is
decreased, demonstrating the suitability of Idylla™ testing for
rapid broad molecular profiling.”
The other studies related to the use of the
Idylla™ EGFR Assay, the Idylla™ MSI Assay and the Idylla™ NRAS-BRAF
Assay2. The Idylla™ study abstracts selected for AMP 2022 can be
downloaded here.
During the AMP
annual meeting, on 2 November 2022, Biocartis will host a free
corporate workshop led by Dr. Rick Ledding, Histology Supervisor at
Benefis Health Systems, sharing his experience on the
implementation of the Idylla™ platform in his laboratory: “Bringing
Rapid Molecular Testing In House: How to Set Up a No-Hassle
Workflow.”
--- END ---
More information: Renate
DegraveHead of Corporate Communications & Investor Relations
Biocartise-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
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.
Please refer to the product labeling for applicable intended uses
for each individual Biocartis product. This press release is not
for distribution, directly or indirectly, in any jurisdiction where
to do so would be unlawful. Any persons reading this press release
should inform themselves of and observe any such restrictions.
Biocartis takes no responsibility for any violation of any such
restrictions by any person. This press release does not constitute
an offer or invitation for the sale or purchase of securities in
any jurisdiction. No securities of Biocartis may be offered or sold
in the United States of America absent registration with the United
States Securities and Exchange Commission or an exemption from
registration under the U.S. Securities Act of 1933, as amended.
Forward-looking
statementsCertain statements, beliefs and opinions in this
press release are forward-looking, which reflect the Company's or,
as appropriate, the Company directors' or managements' 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. No representations and warranties
are made as to the accuracy or fairness of such forward-looking
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obligation or undertaking to release any updates 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
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does either accept any responsibility for the future accuracy of
the forward-looking statements contained in this press release or
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only as of the date of this press release.
1 The Idylla™ platform is cleared in the US under K163628.
Idylla™ EGFR, BRAF, KRAS, MSI, NRAS-BRAF, ctEGFR, ctBRAF, ctKRAS,
ctNRAS-BRAF and GeneFusion assays are all for Research Use Only in
the United States, not for use in diagnostic procedures. For more
information, go to https://www.biocartis.com/en-US 2 Except for the
study performed on the new SeptiCyte RAPID® EDTA blood compatible
cartridges (CE-IVD, not 510(k) cleared), all studies were performed
with Idylla™ RUO assays, for research use only, not for use in
diagnostic procedures3 EDTA represents Ethylenediaminetetraacetic
acid, which is the anticoagulant used for most hematology
procedures (like identifying and counting blood cells, blood
typing, etc.). Source: ksmedical.com, last consulted on 28 Oct
20224 In addition to blood samples collected in PAXgene blood RNA
tubes (per the manufacturer’s instructions), this test is now also
able to process undiluted EDTA blood samples which are commonly
used for most hematology procedures, with results available in
about one hour
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