PRESS RELEASE: 31 July 2018, 07:00 CEST/14:00 CDT
Study Abstract on Performance of Idylla(TM) RAS tests
Selected for Oral Presentation at 70th AACC Annual Scientific Meeting in Chicago, IL (US)
Mechelen, Belgium, 31 July 2018 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that a study abstract[1] on the performance of the Idylla(TM) KRAS and NRAS-BRAF-EGFR492 Mutation Assays[2] compared with Next Generation Sequencing (NGS) using colorectal cancer (CRC) tissue samples was selected for oral presentation at the 70th AACC (American Association for Clinical Chemistry) Annual Scientific Meeting taking place today in Chicago, IL (US). The study concludes that the Idylla(TM) system offers reliable and sensitive testing of mutations in KRAS, NRAS and BRAF directly from FFPE[3] tumor tissue sections, and that it may complement NGS and other molecular testing systems at larger diagnostic centers by providing significantly faster turnaround times through its simplicity and ease of use.
In the study, 44 archived FFPE colorectal cancer (CRC) tissue samples previously analyzed by NGS[4] were tested on Idylla(TM). The Idylla(TM) system successfully detected all of the target KRAS, NRAS and BRAF mutations previously identified by the NGS method, resulting in an Idylla(TM) sensitivity of 100%. Analysis of the control samples[5] demonstrated agreement for all sample results with 100% reproducibility. The Idylla(TM) system produced results easily and quickly, with a turnaround time of approximately two hours.
Herman Verrelst, Chief Executive Officer of Biocartis, commented: “This study demonstrates that the Idylla(TM) system may be suited for any type of diagnostic center, large or small. Its high sensitivity makes it ideal to complement NGS technology in a larger setting, while at the same time Idylla(TM)’s ease-of-use and significantly faster turnaround time makes it also very suitable for small centers that lack highly trained staff and molecular expertise.”
Dr. Gregory Tsongalis, Director, Laboratory for Clinical Genomics and Advanced Technology at the Dartmouth Hitchcock Medical Center, reacted: “The Idylla(TM) system has the potential to play a significant role in rapid screening for actionable mutations prior to NGS analysis. In addition, we have found that for cases where the sample quality is insufficient for NGS, either residual tissue or extracted DNA can be tested in the Idylla(TM) system to generate an actionable result, saving valuable time and effort.”
The study abstract will be presented today at the 70th AACC Annual Scientific Meeting in Chicago, IL (US) at 2:48pm CDT / 7:48am CEST.
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More information:
Renate Degrave
Manager Corporate Communications & Investor Relations
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 fifteen oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.
Biocartis and Idylla(TM) are registered trademarks in Europe, the United States and other countries. Biocartis trademark and logo and Idylla(TM) trademark and logo are used trademarks belonging to 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.
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[1] M. Rabie Al-Turkmani et al., “Rapid Somatic Mutation Testing in Colorectal Cancer Using a Fully Automated System and Single-Use Cartridge: A Comparison with Next-Generation Sequencing”, first presented at 70th AACC Annual Scientific Meeting in Chicago, IL (US).
[2] Research Use Only or RUO, not for use in diagnostic procedures.
[3] Formalin-fixed, paraffin-embedded.
[4] Using the Ion AmpliSeq 50-gene Cancer Hotspot Panel v2 (Thermo Fisher Scientific).
[5] Horizon mutated samples.
