Large Prospective Lung Cancer Study To Be Presented at ESMO
Congress Shows Idylla™ Reduces EGFR Mutation Testing Turnaround
Time by More than a Week, Allowing Faster Patient Management
Decisions
PRESS RELEASE 14 September 2020, 07:00 CEST
Large Prospective Lung Cancer Study To Be
Presented at ESMO Congress Shows Idylla™ Reduces EGFR Mutation
Testing Turnaround Time by More than a Week, Allowing Faster
Patient Management Decisions
Mechelen, Belgium, 14 September
2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’),
an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces that a large prospective lung cancer
study1, co-supported by AstraZeneca, a global science-led
biopharmaceutical company (LON: AZN), has been selected to be
presented at the renowned European Society for Medical Oncology
(‘ESMO’) Virtual Congress taking place between 19-21 September
2020. Rapid and accurate EGFR mutation testing is essential to make
informed treatment decisions2 for patients with advanced non-small
cell lung cancer (NSCLC), and the study concluded that Idylla™
reduced turnaround time by more than a week versus reference
methods, allowing earlier patient management decisions.
The FACILITATE study is a large, prospective,
real-world data set study across 16 European sites3 that was
launched as part of the agreement between Biocartis and
AstraZeneca4, aimed at obtaining faster lung cancer molecular
diagnostic biomarker results in Europe. Between January 2019 and
July 2020 a large set of 1,370 advanced non-small cell lung cancer
(NSCLC) patient samples were tested using the Idylla™ EGFR Mutation
Test5 (CE-IVD) and local reference methods6 including targeted
next-generation sequencing (NGS). Results showed a 97.6%7 overall
percentage agreement between Idylla™ and reference methods. Ninety
percent of all samples were tested in less than 7 days using the
Idylla™ technology, versus less than 21 days using the reference
methods. This demonstrates that Idylla™ improves turnaround time,
allowing for fast-track testing when required, complementary to
slower existing laboratory processes and systems.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “A large study with a broad data
set such as this one with our partner AstraZeneca, who is at the
forefront of lung cancer treatment, shows once again how Idylla™
can make a significant improvement for patients. With Idylla™, a
fully automated rapid EGFR mutation diagnostic workflow8 becomes
possible, decreasing testing turnaround time and allowing earlier
patient management decisions, following diagnosis.”
Prof. Dr. Michael Hummel, Head of the
Molecular Pathology Group, Institute of Pathology, Charite -
Universitätsmedizin Berlin: “Lung cancer often requires
immediate and adequate treatment. Rapid detection of the vast
majority of relevant EGFR mutations provides an excellent targeted
treatment option avoiding chemotherapy. In our large real-world
study it became very obvious that the Idylla™ system is able to
support treatment decisions extremely fast and accurate, much
faster than the in-house solutions applied.”
The abstract poster will be published during the
poster sessions at the ESMO Virtual Congress taking place between
19-21 September 2020 and is available here. Other Idylla™ study
abstracts selected for ESMO can bedownloaded from the ESMO website
here. .
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More information:
Renate DegraveHead of Corporate Communications & Investor
Relations Biocartise-mail
rdegrave@biocartis.comtel +32
15 631 729 mobile +32 471 53 60 64
@Biocartis_ www.linkedin.com/Biocartis
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. More
information: www.biocartis.com. Follow us on Twitter:
@Biocartis_.
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1 Hummel M. et al, “FACILITATE: a real-world multicentre
prospective study investigating the utility of a rapid, fully
automated RT-PCR assay vs reference methods (RM) for detecting
epidermal growth factor receptor mutations (EGFRm) in NSCLC”, ESMO
Virtual Congress 2020 (19-21 September 2020), first published
online on 14 September 2020
2 Epidermal growth factor receptor tyrosine kinase inhibitors
(EGFR-TKIs) are indicated as first-line therapy for patients with
EGFR-mutated (EGFRm) advanced or metastatic NSCLC, where the EGFR
mutational status has been confirmed using a validated and approved
test method
3 In Belgium, France, Germany and Italy. The study aimed to
prospectively test 100 paraffin-embedded biopsy or cytology tissue
samples with ≥10% neoplastic cells per site, from patients with
advanced NSCLC
4 Announced on 29 November 2018, see here
5 The Idylla™ EGFR Mutation Test qualitatively detects all
relevant EGFR mutations in exons 18–21 as recommended by the ESMO,
ASCO, NCCN, and CAP/IASLC/AMP guidelines for determining the most
appropriate patient management for patients with advanced NSCLC. In
total, 51 mutations are detected
6 Reference methods were targeted next-generation sequencing
(NGS, different gene panels), Cobas® EGFR Mutation Test, Sanger
sequencing, Pyro sequencing, Sequenom mass spectrometry, Hybrid
Capture, and Entrogen EGFR Mutation Analysis Kit
7 The 3% discordance observed was partially attributable to
rarer mutations that Idylla™ is not designed to detect
8 Idylla™ EGFR Mutation Test is intended to aid in the assesment
of mutational status of patients with lung cancer and to facilitate
treatment decisions within a multidisciplinary team
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