Press news Biocartis Group NV: Biocartis Launches Idylla™ SARS-CoV-2/Flu/RSV Panel
02 September 2021 - 7:00AM
Press news Biocartis Group NV: Biocartis Launches Idylla™
SARS-CoV-2/Flu/RSV Panel
PRESS RELEASE: 2 September 2021, 07:00
CEST
Biocartis
Launches
Idylla™
SARS-CoV-2/Flu/RSV Panel
Mechelen,
Belgium, 2 September
2021 – Biocartis Group NV (the ‘Company’ or
‘Biocartis’), an innovative molecular diagnostics company (Euronext
Brussels: BCART), today announces the launch of its Idylla™
SARS-CoV-2/Flu/RSV Panel (CE-IVD). Building upon the success of its
Idylla™ SARS-CoV-2 Test (CE-IVD), the new Panel is launching as a
CE-IVD and detects, in one single cartridge, SARS-CoV-2, Flu A/B
and RSV1 nucleic acids, with results in approx. 90 minutes.
The Idylla™ SARS-CoV-2/Flu/RSV Panel is a fully
automated rRT-PCR2 test intended for the qualitative detection of
SARS-CoV-2, Flu A/B and RSV nucleic acids in nasopharyngeal swab
specimens from individuals suspected of respiratory infections by
their healthcare provider. The nasopharyngeal swab specimens are
collected in a viral transport medium3 and can be pipetted directly
into the cartridge. The Idylla™ SARS-CoV-2/Flu/RSV Panel includes
fully automated nucleic acid testing with the extraction,
amplification and detection in a single-use cartridge, with less
than 1 minute hands-on time.
The Panel showed excellent performance in the
clinical performance study4 with 98% overall concordance compared
with other currently used methods.
Commenting on the
launch of the
Idylla™
SARS-CoV-2/Flu/RSV Panel, Herman
Verrelst, Chief Executive Officer of
Biocartis, said: “We take an
important next step in strengthening our infectious disease menu by
upgrading the Idylla™ SARS-CoV-2 Test5 (CE-IVD) to a Panel that now
also includes Flu A/B and RSV. Ahead of a delayed flu season, this
Panel is well positioned to guide healthcare providers in this
complex landscape of respiratory infections in 2022.”
The timing of the Emergency Use Authorization (‘EUA’) submission
to the US FDA of the Idylla™ SARS-CoV-2/Flu/RSV Panel is still to
be decided.
--- 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
SARS-CoV-2/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. The Idylla™
SARS-CoV-2/Flu/RSV Panel contains SuperScript™ III Reverse
Transcriptase and is provided subject to a license under patents or
patent applications owned by or licensed to Life Technologies
Corporation, which license is limited to the human diagnostic field
and research field and specifically excludes applications in
forensics (including human identity testing). The SuperScript™ III
trademark is owned by Life Technologies Corporation. 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
performance and should not be taken as a representation that such
trends or activities will continue in the future. In addition, even
if actual results or developments are consistent with the
forward-looking statements contained in this press release, those
results or developments may not be indicative of results or
developments in future periods. No representations and warranties
are made as to the accuracy or fairness of such forward-looking
statements. As a result, the Company expressly disclaims any
obligation or undertaking to release any updates or revisions to
any forward-looking statements in this press release as a result of
any change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based, except if specifically required to do so by
law or regulation. Neither the Company nor its advisers or
representatives nor any of its subsidiary undertakings or any such
person's officers or employees guarantees that the assumptions
underlying such forward-looking statements are free from errors nor
does either accept any responsibility for the future accuracy of
the forward-looking statements contained in this press release or
the actual occurrence of the forecasted developments. You should
not place undue reliance on forward-looking statements, which speak
only as of the date of this press release.
1 Respiratory Syncytial Virus2 Real-Time Reverse
Transcription-Polymerase Chain Reaction3 Of which 400 µl VTM is
used in Idylla™ 4 Performance was evaluated across two arms of a
clinical evaluation, all samples were residual nasopharyngeal swab
in viral transport media. In the first arm 322 specimens were
collected to evaluate the performance of the Idylla™
SARS-CoV-2/Flu/RSV Panel compared to the DiaSorin Molecular
Simplexa™ Flu A/B & RSV Direct. In the second arm 341 specimens
were collected to evaluate the performance of the Idylla™
SARS-CoV-2/Flu/RSV Panel compared to the Luminex Aries® SARS-COV-2
Assay. More information here5 The Idylla™ SARS-CoV-2 Test (CE-IVD)
will remain available
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