PRESS RELEASE – Friday, 7 October 2016, 07:00 CEST
THREE IDYLLA(TM) TEST PERFORMANCE STUDIES TO BE PRESENTED AT ESMO ONCOLOGY CONFERENCE
Mechelen, Belgium, 7 October 2016 – Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that three studies on the performance of its Idylla(TM) based molecular diagnostic tests will be presented at the renowned annual conference of the European Society for Medical Oncology (ESMO), to be held from 7-11 October 2016 in Copenhagen (Denmark).
The ESMO conference is a major scientific oncology conference, attracting an international community of experts across various disciplines, all focused on finding the most effective cancer treatment solutions available today. With approximately 20,000 attendees from all over the world, it offers a key platform for academic groups and companies to present their latest advances in oncology research.
Below is a summary of the performance studies presented at ESMO for three different Idylla(TM) tests:
- AstraZeneca KRAS Comparison Study: concerns a comparison study organised by AstraZeneca, a global biopharmaceutical company, which assessed KRAS mutation detection and functional characteristics such as time-to-result and sensitivity across 12 different KRAS diagnostics technologies commonly used in clinical practice, including the Idylla(TM) KRAS Mutation Test.
- Idylla(TM) NRAS-BRAF-EGFRS492R Mutation Assay Comparison Study: discloses results of a comparison of the Idylla(TM) NRAS-BRAF-EGFRS492R Mutation Assay with routine sequencing technologies at five European centers.
- Idylla(TM) EGFR Mutation Assay Performance Study: concerns a study on the Idylla(TM) EGFR Mutation Assay (Research Use Only), assessed on so-called cell line derived materials and on formalin-fixed paraffin-embedded (FFPE) tissue slices from 141 non-small-cell lung cancer samples.
Biocartis can be visited at booth number 428 at ESMO.
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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 has five oncology tests and two infectious disease tests. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ 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. As a result, the Company expressly disclaims any obligation or undertaking to release any update 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. 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.
 J.L. Sherwood et al., KRAS – ESMO Abstract 91 P: “Implications of key differences across 12 KRAS mutation detection technologies and their relevance in clinical practice”, publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w.
 Performed on 56 DNA samples derived from well-characterized cell lines (no FFPE samples). A cell line is a clone of cultured cells derived from an original patient sample.
 Now available as CE-marked IVD test.
 Ellen Vercauteren et al., NRAS – ESMO Abstract 1175P: “Ultra-rapid, sensitive, and fully automated extended RAS testing for metastatic colorectal cancer – evaluation of an NRAS/BRAF/EGFR492 module”, publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w.
 Research Use Only.
 Preliminary Performance Study based on Research data. Martin Reijans et al., EGFR – ESMO Abstract 1173P: “Fully automated and sensitive detection of EGFR exon 18, 19, 20 and 21 mutational status in less than 2.5 hours from a single FFPE slice”, publically available on https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-10-10#2z95w.
 Cytological specimens.