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@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: @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.
[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.
