Press release Biocartis NV.: Biocartis Launches Liquid Biopsy Idylla™ ctEGFR Mutation Assay

PRESS RELEASE: 25 October 2019, 07:00 CEST 
Biocartis Launches Liquid Biopsy Idylla™ ctEGFR Mutation Assay
Mechelen, Belgium, 25 October 2019 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the launch of the Idylla™ ctEGFR Mutation Assay (RUO¹). This assay is the liquid biopsy version of the solid biopsy Idylla™ EGFR Mutation Test (CE-IVD) and is further strengthening Biocartis’ testing menu.
Obtaining samples for biomarker testing of sufficient quantity and quality is known to be a major challenge in several cancer types, including lung cancer. Solid tumor tissue samples might be too small, the tumor content might be too low or the tumor might be hard to reach. In these cases, liquid biopsy testing could provide for a solution. The Idylla™ ctEGFR Mutation Assay (RUO) is a liquid biopsy assay, performed on Biocartis’ Idylla™ platform, which allows the detection of 49 EGFR mutations² directly from 2 ml of blood plasma and providing results within approximately 160 minutes.During the recent European Society for Medical Oncology (ESMO) Congress³, a first performance study⁴ was published on the prototype liquid biopsy Idylla™ ctEGFR Mutation Assay. The study included 64 non-small cell lung cancer (NSCLC) samples and concluded that the prototype Idylla™ ctEGFR Mutation Assay detected all mutations previously detected by the comparison method (Next-Generation Sequencing or NGS⁵). In 33 samples, NGS detected no mutation whereas the Idylla™ ctEGFR Mutation Assay detected eight additional mutations in this cohort⁶.Herman Verrelst, Chief Executive Officer at Biocartis, commented: “We are excited to further expand our Idylla™ menu of tests with the launch of the liquid biopsy ctEGFR Mutation Assay (RUO). Operating directly on only 2 ml of blood plasma, this assay provides our customers with the ease-of-use and speed of the Idylla™ platform and has great potential to provide solutions in cases where cancer tissue is not or not sufficiently available. This assay launch further strengthens our testing menu, which will be further complemented by the expected launch of our Idylla™ GeneFusion Panel next year, focused on the detection of different gene fusions that are currently recommended in the guidelines.”— END —More information:Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-mail   rdegrave@biocartis.com
tel         +32 15 631 729
mobile   +32 471 53 60 64
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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™ 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 is developing and marketing a continuously expanding test menu addressing key unmet clinical needs in oncology. This represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned 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 statementsCertain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ 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. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates 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, except if specifically required to do so by law or regulation. 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. [1] RUO = Research Use Only, not for use in diagnostic procedures
[2] Including insertions and deletions in exon 18, 19, 20 and 21 in the EGFR gene
[3] 27 September – 1 October 2019 in Barcelona (Spain)
[4] Study conducted by Biocartis: Reijans et al., ESMO 2019
[5] Sensitivity 2-5%
[6] Confirmed after retesting with the cobas EGFR Mutation Test v2. Of the 8 additional mutations, 7 mutations were detected in samples which were scored wild type by NGS