Publication date: 16/11/2017
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 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.
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.
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_.