Press release Biocartis Group NV: Biocartis Announces New Agreement with AstraZeneca for the Development and Marketing of a Companion Diagnostic Test for Tagrisso®
22 Juni 2022 - 7:00AM
PRESS RELEASE: 22 June 2022, 07:00 CEST
Biocartis Announces
New Agreement with
AstraZeneca for the
Development and
Marketing of a
Companion Diagnostic
Test for
Tagrisso®
Mechelen, Belgium,
22 June
2022 – Biocartis
Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular
diagnostics company (Euronext Brussels: BCART), today announced
that it has entered into an agreement with AstraZeneca
(LSE/STO/Nasdaq: AZN) aimed at the development and applicable
pre-market notification or approval with the US FDA of a novel
companion diagnostic1 (CDx) test on Biocartis’ molecular rapid and
easy-to-use diagnostics Idylla™ platform, for use with Tagrisso®
(osimertinib), AstraZeneca’s third-generation EGFR-TKI (tyrosine
kinase inhibitor) treatment.
Under the terms of the agreement, Biocartis and
AstraZeneca will co-lead the development and applicable pre-market
notification or approval of the Idylla™ EGFR CDx Assay intended to
aid in identifying patients with non-small cell lung cancer (NSCLC)
who may respond to treatment with Tagrisso®. In addition to FFPE2
tissue, Biocartis will seek to validate the use of less invasive
cytology samples such as fine needle aspirates3 for use with the
Idylla™ EGFR CDx Assay, to expand patient access to testing.
The new project expands the existing master
collaboration agreement announced in January 2020 between Biocartis
and AstraZeneca4, aimed at boosting access to faster molecular
diagnostic biomarker results with the rapid and easy-to-use Idylla™
EGFR testing products. The collaboration was supported by the large
prospective lung cancer FACILITATE study, co-sponsored by
AstraZeneca. This study concluded that Idylla™ EGFR testing may add
value in a clinical setting to generate actionable EGFR mutation
results for NSCLC patients faster than routinely used methods. In
this respect, the newly signed agreement includes the
investigational use of the Idylla™ EGFR CDx Assay to enroll
patients in clinical trials at AstraZeneca.
AstraZeneca is marketing Tagrisso®, a leading
lung cancer therapy approved for patients with resectable and
locally advanced or metastatic NSCLC whose tumors have EGFR
mutations. EGFR activating mutations are important biomarkers in
NSCLC, occurring in 10-15% of all NSCLC patients in the US and the
EU, and in 30-40% of all NSCLC patients in Asia5.
Herman Verrelst, Chief Executive Officer
of Biocartis, commented: “We are excited to move our
collaboration with AstraZeneca to a next level with the development
of a companion diagnostic test on Idylla™ that may enable faster
and broader patient access to AstraZeneca’s Tagrisso® treatment.
Current EGFR molecular diagnostic testing remains a real challenge
in the clinical practice. Obtaining high quality tissue samples is
difficult and complex, especially in NSCLC where tumors are
frequently very small, often leading up to several weeks of waiting
time before results are available, as opposed to what we can offer
with the Idylla™ technology.”
--- 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.
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
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trends or activities will continue in the future. In addition, even
if actual results or developments are consistent with the
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results or developments may not be indicative of results or
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obligation or undertaking to release any updates or revisions to
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1 A companion diagnostic (CDx) test is a test
used as a companion to a therapeutic drug that helps predict if a
patient is likely to respond to a treatment or not2 FFPE = formalin
fixed, paraffin embedded3 Processed into FFPE cell blocks4 First
collaboration expansion was announced in May 2021 and was supported
by AstraZeneca’s large prospective lung cancer FACILITATE study
(Hummel M. et al, “FACILITATE: a real-world multicenter 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 Sept 2020), first published online on 14 Sept 2020.
Poster was presented at ESMO 2020 (European Society for Medical
Oncology), poster reference 1205P5 Source:
https://www.astrazeneca.com/our-focus-areas/oncology/at-the-forefront-of-lung-cancer-treatment.html,
last consulted on 10 June 2022
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