Press release Biocartis Group NV: Biocartis Announces Launch of its
Rapid CE-marked IVD Idylla™ GeneFusion Panel for Fast Treatment
Decisions in Lung Cancer
PRESS RELEASE: 20 June 2022, 07:00 CEST
Biocartis Announces
Launch of its Rapid
CE-marked IVD
Idylla™ GeneFusion Panel
for Fast Treatment
Decisions in Lung Cancer
- Idylla™ GeneFusion Panel available as rapid CE-marked IVD lung
cancer testing solution for laboratories, with results within 180
minutes
- 10% to 20% of advanced lung cancer patients don’t receive the
appropriate targeted therapy due to slow turnaround time of many
current testing methods, leading to a delayed
time-to-treatment1
Mechelen, Belgium,
20 June
2022 – Biocartis
Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular
diagnostics company (Euronext Brussels: BCART), announces the
CE-marking of its fully automated Idylla™ GeneFusion Panel
(CE-IVD). The Panel detects in one single cartridge ALK, ROS1, RET
and METex14 skipping, a wide range of actionable targets relevant
in non-small cell lung cancer (NSCLC). Designed for use in clinical
laboratories, the Panel provides comprehensive testing results
within 180 minutes, significantly faster than currently available
testing methods which often take days or even weeks before results
are available.
Lung cancer remains the leading cause of cancer
deaths, with NSCLC being the most common type of lung cancer. The
survival rate has increased over the past years due to the rapidly
evolving treatment landscape for NSCLC. Gene fusions represent an
important class of gene rearrangements and have become important in
NSCLC, as they are linked to responses to certain targeted
therapies. Their accurate and fast detection is critical to guide
therapy choices, which is the reason why testing for gene
rearrangements such as gene fusions is included in international
NSCLC testing guidelines (including ESMO and NCCN).
However, comprehensive testing of actionable
gene rearrangements in NSCLC is often complex and can require
different technologies2. In order to test all needed biomarkers,
laboratories usually have to use different instruments which are
often not available within their own lab. Using different
instruments also requires having enough biopsy samples of
sufficient good quality, which can be difficult to obtain,
especially in NSCLC patients.
Commenting on the launch of
the Idylla™ GeneFusion
Panel, Herman Verrelst, Chief Executive
Officer of Biocartis, said: “Turnaround time and
time-to-treatment remains an important barrier to molecular
testing. It has been demonstrated that 10% to 20% of advanced lung
cancer patients do not receive the appropriate targeted therapy
because biomarker results are not provided in a timely fashion1.
With the CE-marked IVD of the Idylla™ GeneFusion Panel,
laboratories will have a rapid actionable and in-house solution at
their disposal which can be seamlessly integrated into virtually
any laboratory workflow.”
The Idylla™ GeneFusion Panel consolidates
traditional testing workflows into one streamlined, fully-automated
process which provides reliable information on ALK, ROS1, RET and
METex14 skipping and delivers results within 180 minutes. Moreover,
the Panel only requires a limited amount of sample, thereby saving
valuable tissue specimens. The Idylla™ GeneFusion Panel
demonstrated high concordance results in a clinical comparison
study where ALK was compared with IHC, and ROS1, RET and METex14
skipping were compared with NGS3.
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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
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, as well as for COVID-19, flu,
RSV and sepsis. 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.
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,
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and other factors that could cause actual results or events to
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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
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Forward-looking statements contained in this press release
regarding past trends or activities are not guarantees of future
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if actual results or developments are consistent with the
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only as of the date of this press release.
1 Finall et al. Integration of rapid PCR testing as an adjunct
to NGS in diagnostic pathology services within the UK: evidence
from a case series of non-squamous, non-small cell lung cancer
(NSCLC) patients with follow-up? J Clin Pathol. 5 Jan 2022 Chu et
al. Clinical Utility and Performance of an Ultrarapid Multiplex
RNA-Based Assay for Detection of ALK, ROS1, RET, and NTRK1/2/3
Rearrangements and MET Exon 14 Skipping Alterations. J Mol Diagn.
2022 Apr2 I.e. gene fusions and METex14 skipping. 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 2 June 20223 Data obtained from the clinical
performance evaluation performed by Biocartis in view of the
CE-marking. The clinical performance evaluation compared the
Idylla™ GeneFusion Panel with IHC (VENTANA ALK (D5F3) Assay, Roche
Diagnostics GmbH) for ALK; ROS1, RET and METex14 skipping were
evaluated versus NGS (Oncomine™ Focus Assay, Thermo Fisher
Scientific)
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