Biocartis Group NV: Idylla(TM) Performance Data Presented by US Key Opinion Leaders at Association for Molecular Pathology 2017 Conference
(Thomson Reuters ONE) -
PRESS RELEASE: 15 November 2017, 18:00 CET / 10:00 MST
Idylla(TM) Performance Data Presented by US Key Opinion Leaders at Association
for Molecular Pathology 2017 Conference
Mechelen, Belgium, 15 November 2017 - Biocartis Group NV (the 'Company' or
'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces that Idylla(TM) performance data was presented during
the Biocartis workshop at the annual Association for Molecular Pathology (AMP)
meeting.
Two key opinion leaders (KOLs) from renowned oncology centers, Dr. Kanwal
Raghav, MD, MBBS (Gastrointestinal Medical Oncology, MD Anderson Cancer Center,
Houston, Texas, US) and Dr. Gregory J. Tsongalis, BS, MS, PhD (Professor of
Pathology, Dartmouth Hitchcock Medical Center, New Hampshire, US) discussed key
challenges that molecular diagnostic (MDx) testing is still facing in the US,
especially around long turnaround times. Both KOLs also highlighted the need for
fast molecular testing.
Furthermore, Dr. Gregory Tsongalis presented results from an internal study
comparing the performance of the Idylla(TM) KRAS, NRAS and BRAF tests to the
internal Standard of Care[1] methods at the Dartmouth Hitchcock Medical Center,
in this case based on a Next-Generation Sequencing (NGS) technology. The study
was performed on 53 archived formalin-fixed paraffin-embedded (FFPE) colorectal
cancer tissue samples, indicating full concordance with the Standard of Care
method in terms of sensitivity, specificity and predictive value[2].
Vishal Sikri, General Manager of Biocartis US Inc., commented: "The value of the
Idylla(TM) platform continues to be demonstrated in studies being completed in
the US as part of our market adoption strategy. With over 500 placements
globally today, the Idylla(TM) platform and its current MDx assay offering is
attractive to any lab in the US thinking of bringing in or optimizing their
current MDx testing. With assay turnaround times of between 90 to 150 minutes
and a maximum hands-on time of two minutes, the Idylla(TM) assays include all
features for labs in the US looking for rapid, easy and accurate molecular test
results."
Biocartis launched the commercialization of its oncology test menu (for research
use only) in the US through its subsidiary, Biocartis US Inc., and its official
distributor Thermo Fisher Scientific Inc[3].
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More information:
Renate Degrave
Manager Corporate Communications & Investor Relations Biocartis
e-mail rdegrave(at)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(TM) 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 launched the Idylla(TM) platform in September
2014. Biocartis is developing and marketing a rapidly expanding test menu
addressing key unmet clinical needs in oncology and infectious diseases. These
areas represent respectively the fastest growing and largest segments of the MDx
market worldwide. Today, Biocartis offers ten oncology tests and two infectious
disease tests in Europe. More information: www.biocartis.com. Press Photo
Library available here. Follow us on Twitter: (at)Biocartis_.
The Biocartis trademark and logo are trademarks of Biocartis and are used and
registered in Europe. Idylla(TM) is a registered trademark in the United States
and other countries. The Idylla(TM) trademark and logo are trademarks of and
used by Biocartis. 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. Please refer to the product labeling for applicable
intended uses for each individual Biocartis product. 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 statements
This press release may contain forward-looking statements. Such forward-looking
statements are not guarantees of future performance. These forward-looking
statements speak only as of the date of this press release. Biocartis expressly
disclaims any obligation or undertaking to release any updates or revisions to
any forward-looking statements in this press release. You should not place undue
reliance on forward-looking statements.
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[1]Standard of Care is a diagnostic and treatment process that a clinician
should follow for a certain type of patient, illness, or clinical circumstance.
Source: https://www.medicinenet.com/script/main/art.asp?articlekey=33263, last
consulted on 13 November 2017.
[2] The study was performed on 53 archived formalin-fixed paraffin-embedded
(FFPE) colorectal cancer samples in the Dartmouth Hitchcock Medical Center.
Compared to the NGS technology, Idylla(TM) scored 100% on sensitivity,
specificity and positive & negative predictive value. Study results were first
presented at the Biocartis Corporate Workshop held at the Association for
Molecular Pathology (AMP) 2017 Annual Meeting, 15 November 2017, US.
[3] The agreement was signed with Fisher HealthCare, part of Thermo Fisher
Scientific Inc.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 15.11.2017 - 18:00 Uhr
Sprache: Deutsch
News-ID 568352
Anzahl Zeichen: 7286
contact information:
Town:
Mechelen
Kategorie:
Business News
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