Press release Biocartis Group NV: New Study Demonstrates Idylla™
EGFR Mutation Test (CE-IVD) Shortens Time to Patient Management
Decisions for Patients with Non-Small Cell Lung Cancer
PRESS RELEASE: 16 November 2021, 07:00 CET
New Study Demonstrates
Idylla™ EGFR Mutation Test (CE-IVD) Shortens Time
to Patient Management
Decisions for Patients with Non-Small Cell
Lung Cancer
Mechelen,
Belgium, 16 November
2021 – Biocartis Group NV (the ‘Company’ or
‘Biocartis’), an innovative molecular diagnostics company (Euronext
Brussels: BCART), today announces the publication of a new study1
that demonstrates that the Idylla™ EGFR Mutation Test (CE-IVD)
running on Biocartis’ molecular diagnostics Idylla™ platform
improves patient management decisions for patients with non-small
cell lung cancer (NSCLC) through the faster screening of EGFR
mutations.
Nearly 85% of lung cancers are non-small cell
lung cancers2. EGFR or ‘Epidermal Growth Factor Receptor’ mutations
are the second most common cancer driver mutation in NSCLC. EGFR
testing is important for the detection of EGFR mutations which
helps to determine whether someone with NSCLC may benefit from
targeted therapy-based regimens in case of presence of EGFR
mutations, or potentially from immunotherapy-based regimens in case
of absence of EGFR mutations3. EGFR mutations are commonly assessed
by using Next-Generation Sequencing (NGS). This is a more complex
and time-consuming technology, leading to an average expected
time-to-result of approx. 15 days, which delays informed patient
management decisions for patients with NSCLC.
The Idylla™ EGFR Mutation Test is a fully
automated test using a slice of formalin-fixed, paraffin embedded
(FFPE) tissue material as sample input, requiring less than 2
minutes hands-on-time and generating results in about 150 minutes.
Previous studies4 have already reported excellent concordance
between the Idylla™ EGFR Mutation Test and other routine EGFR
testing methods, including NGS. This new study however specifically
investigated if the faster time-to-result of the Idylla™ EGFR
Mutation Test could shorten the time to patient management
decisions for patients with NSCLC, as compared to NGS.
The study compared EGFR mutations analysis
between the Idylla™ platform using the Idylla™ EGFR Mutation Test,
and NGS in 223 patients with NSCLC. Idylla™ demonstrated 96.4%
overall agreement with NGS and did not generate any false positive
results5. On average, EGFR results using Idylla™ became available
12.6 calendar days earlier compared to NGS. As a result, with
Idylla™, the timeframe from tumor sampling to the initiation of
treatment was 16.1 calendar days earlier compared to NGS. The study
concluded that the Idylla™ platform contributes to improving
patient management decisions for patients with NSCLC through the
faster screening of EGFR mutations.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “This new
publication clearly shows the high clinical value of our Idylla™
EGFR Mutation Test. The study demonstrates it is a sensitive and
rapid solution for the detection of EGFR mutations with a
significantly faster turnaround time compared to NGS. On average,
with Idylla™, time to patient management decisions was shortened
with two weeks compared to the use of NGS.”
The study can be consulted on the website of ‘Current Oncology’
here.
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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.
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for each individual Biocartis product.
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1 Petiteau, C.; Robinet-Zimmermann, G.; Riot,
A.; Dorbeau,M.; Richard, N.; Blanc-Fournier, C.; Bibeau, F.;
Deshayes, S.; Bergot, E.; Gervais, R.; et al. Contribution of the
Idylla™ System to Improving the Therapeutic Care of Patients with
NSCLC through Early Screening of EGFR Mutations. Curr. Oncol. 2021,
28, 4432–4445. https://doi.org/10.3390/curroncol28060376, published
3 November 20212 Hutchinson, B.; Shroff, G.S.; Truong, M.T.; Ko,
J.P. Spectrum of lung adenocarcinoma. Semin. Ultrasound CT MRI
2019, 40, 255–2643 Hofman, P. EGFR Status Assessment for Better
Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing
in the Daily Practice of Pathologists? Cells 2021, 10, 2157.
https://doi.org/ 10.3390/cells10082157, first published on 21 Aug
2021 4 More info on www.biocartis.com/publications5 The Idylla™
EGFR Mutation Test (CE-IVD) detected 20 of the 26 (77%) EGFR
mutations that were detected using NGS. Regarding the seven missed
EGFR mutations, five were not detected by design by the Idylla™
EGFR Mutation Test, one was assayed in a sample with insufficient
neoplastic cell content for Idylla™, and the last was in a sample
not validated by the Idylla™ EGFR Mutation Test (a bone
metastasis)
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