Press release Biocartis Group NV: New Study Led by Memorial Sloan
Kettering Cancer Center (NY, US) Shows Idylla™ GeneFusion Assay
Enables More Rapid Screening of Targetable Fusions Compared to
Routine Methods
PRESS RELEASE: 4 May 2022, 07:00 CEST
New Study
Led by Memorial Sloan
Kettering Cancer Center (NY, US) Shows
Idylla™ GeneFusion Assay Enables More
Rapid Screening of
Targetable Fusions
Compared to Routine Methods
- Therapeutically actionable gene
fusions drive approximately 10% of non-small-cell lung
cancers1
- Current molecular methods including
Next Generation Sequencing (NGS) are complex with long turnaround
times
- Study2 demonstrates the Idylla™ GeneFusion Assay (RUO3) enables
more rapid screening of targetable fusions compared to routine
methods
Mechelen, Belgium,
4 May
2022 – Biocartis
Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular
diagnostics company (Euronext Brussels: BCART), today announces the
publication of a new study in the Journal of Molecular Diagnostics
on the Idylla™ GeneFusion Assay (RUO) for rapid detection of
targetable fusions involving ALK, ROS1, RET, and NTRK1/2/3 and MET
exon 14 skipping mutations. The study concluded: “The assay enables
rapid screening for clinically actionable kinase alterations with
quicker turnaround and lower tissue requirements compared to
immunohistochemistry and molecular methods, while also
circumventing the infrastructure dependencies associated with Next
Generation Sequencing (NGS) and fluorescence in situ
hybridization”. The study was performed by Memorial Sloan Kettering
Cancer Center (NY, US), one of the largest private cancer centers
in the world.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “This study shows the Idylla™
GeneFusion Assay’s added value when rapid testing is needed, and
highlights other benefits including the Assay’s low tissue
requirements that still allow for further NGS testing in negative
cases, and perhaps most importantly, the results are delivered in
three hours due to the fully automated nature of the Assay, where
other methods today often take several days to weeks.”
Therapeutically actionable gene fusions drive
approximately 10% of non-small-cell lung cancers1 (NSCLC). Up to
40% of rearrangement-driven lung cancers are diagnosed at an
advanced stage (III to IV)4, however tyrosine kinase inhibitor
therapy typically induces rapid and profound clinical improvement5.
As such, timely recognition of these alterations is critical in the
clinic. Current methods to detect kinase fusions such as
fluorescence in situ hybridization (FISH) or NGS can be complex to
perform, require a large lab infrastructure, have long turnaround
times and can be cumbersome when it comes to interpretation of the
data. Although NGS has become the mainstay for high throughput
therapeutic target search, most NGS assays have high tissue
requirements, need turnaround times of 2 to 3 weeks and bring about
underlying genomic and biologic complexities that can lead to
false-negative gene fusion results.
The study analyzed 143 independent FFPE6 tumor
samples. The study stated that “testing was successful in 142 (99%)
cases”. Furthermore, the study stated that “the Idylla™ GeneFusion
Assay demonstrated a sensitivity of 97% (28/29), 100% (31/31), 92%
(22/24), 81% (22/27), and 100% (20/20) for ALK, RET, ROS1, and
NTRK1/2/3 rearrangements and MET exon 14 skipping alterations,
respectively, with 100% specificity for all.”
The fully automated Idylla™ GeneFusion Assay
(RUO) detects ALK, ROS1, RET, NTRK1/2/3 rearrangements and MET exon
14 skipping in a single cartridge, with less than 2 minutes
hands-on time and results available in approx. 180 minutes.
The CE-IVD version of the Idylla™ GeneFusion
Panel is planned for end of H1 2022.
--- 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
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.
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1 Lee SE, et al., ‘Comprehensive analysis of RET and ROS1
rearrangement in lung adenocarcinoma’, Mod Pathol 2015, 28:468e479;
and Pan Y et al., : ‘ALK, ROS1 and RET fusions in 1139 lung
adenocarcinomas: a comprehensive study of common and fusion
pattern-specific clinicopathologic, histologic and cytologic
features’, Lung Cancer 2014, 84:121e1262 M. Arcila 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’, Published 14
April 2022, DOI:
https://www.jmdjournal.org/article/S1525-1578(22)00080-0/fulltext 3
Research Use Only, not for use in diagnostic procedures4 Kim H et
al., ‘A comprehensive comparative analysis of the
histomorphological features of ALK-rearranged lung adenocarcinoma
based on driver oncogene mutations: frequent expression of
epithelial-mesenchymal transition markers than other genotype’,
PLoS One 2013, 8:e769995 Kitazawa S, et al., ‘Successful use of
extracorporeal membrane oxygenation for airway-obstructing lung
adenocarcinoma’, Thorac Cancer 2020, 11:3024e30286 Formalin Fixed,
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