BCART Biocartis Group NV

Press release Biocartis Group NV: Four Abstracts Showing Excellent Data for Idylla™ Presented at European Society of Molecular Oncology Congress (ESMO)

PRESS RELEASE 20 October 2023, 07:00 CEST

Four Abstracts Showing Excellent Data for Idylla™ Presented at European Society of Molecular Oncology Congress (ESMO)

Mechelen, Belgium, 20 October 2023 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces that four study abstracts on Idylla™ have been selected for poster presentations at the international ESMO (European Society of Molecular Oncology) congress, taking place between 20-24 October 2023 in Madrid (Spain). The studies show excellent data for the Idylla™ GeneFusion Assay and Idylla™ EGFR Mutation Assay.

Three studies demonstrate that the Idylla™ GeneFusion and EGFR Mutation Assays offer a rapid, sensitive and specific method for lung sample profiling in routine practice.

• The first study1 prospectively tested lung cancer samples on the Idylla™ Platform as part of routine2 lung profiling locally and from over 60 UK hospitals. The investigators tested over 5,000 cases and demonstrated that the Idylla™ GeneFusion Assay had the expected rate of positivity and a low failure rate. Moreover, the Assay allowed testing to be successfully completed in samples unsuitable for NGS due to low tumor burden.
• The second abstract3 presents the results of a multicenter study that was conducted in a routine clinical2 setting involving 12 clinical centers across Europe. Providing high sensitivity and specificity values for all biomarkers, together with a low failure rate and rapid turnaround time (within 3 hours), the investigators concluded that the Idylla™ GeneFusion Assay technology has emerged as a highly relevant, time efficient and upfront screening tool on FFPE samples.
• The third abstract4 presents the results of the ORIGEN study, a multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain (in collaboration with AstraZeneca Spain). The investigators demonstrated a 15% frequency of EGFR mutations, with the most frequent being exon 19 deletions and the presence of the L858R mutation, which is in line with other data reported in Spain in advanced NSCLC. These results reinforce the importance of performing EGFR testing in early-stage NSCLC to predict the most appropriate treatment options.

The fourth abstract5 describes a research project that aims to identify the feasibility of the Idylla™ GeneFusion Assay in detecting RET fusions in Papillary Thyroid Cancer (PTC).

Roger Moody, Chief Executive Officer of Biocartis, commented: “I am proud that independent researchers confirm the excellent performance of our products, especially the studies on the Idylla™ GeneFusion Assay, which demonstrates that this assay can be valuable for various cancer indications. The confirmation of the low invalid rates of our products in combination with their fast time to result, are a confirmation of the benefits of our Idylla™ Platform compared to other technologies such as NGS.”

The four study abstracts on Idylla™ which have been selected for ESMO, can be downloaded here: https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal_2/presentation/list?

        

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About Biocartis

With its revolutionary and proprietary Idylla™ Platform, Biocartis (Euronext Brussels: BCART) aspires to enable personalized medicine for patients around the world through universal access to molecular testing, by making molecular testing actionable, convenient, fast and suitable for any lab. The Idylla™ Platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) based system designed to offer in-house access to accurate molecular information in a minimum amount of time for faster, informed treatment decisions. Idylla™'s continuously expanding menu of molecular diagnostic tests address key unmet clinical needs, with a focus in oncology. This is the fastest growing segment of the molecular diagnostics market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal, lung, breast and liver cancer, as well as for sepsis. More information: www.biocartis.com. Follow us on X (Twitter): @Biocartis_.

Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, cleared for sales in the US and registered in many others countries. 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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. 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. 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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Certain 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 First study. 1307P - The Biocartis Idylla GeneFusion Assay (RUO) for lung cancer testing: The experience of testing over 5000 tumours in routine practice. Presentation Number: 1307P. Speakers: Lee Robertson (Birmingham, United Kingdom). Onsite Poster display date: Saturday, 21 October 2023.2 Biocartis NV can supply A0120/6 Idylla™ GeneFusion Panel, which is a CE-marked product according to the IVD directive 98/79/CE.3 Second study. 1430P - Excellent performance of a fast and fully-automated RNA based genefusion assay conducted on a large fusion positive non-small cell lung cancer cohort within a multicenter study. Presentation Number: 1430P. Speakers: Arndt Hartmann (Erlangen, Germany). Onsite Poster display date: Monday, 23 October 2023.4 Third study. 1278P - ORIGEN: Multicenter study on the prevalence of EGFR gene mutations in patients with early-stage resectable non-small cell lung cancer in Spain. Presentation Number: 1278P. Speakers: Ernest Nadal (L'Hospitalet de Llobregat, Spain). Onsite Poster display date: Saturday, 21 October 2023.5 Fourth study. 2223P - Next-generation sequencing enables identification of RET rearrangements in papillary thyroid cancer. Presentation Number: 2223P. Speakers: Sergi Clavé (Barcelona, Spain). Onsite Poster display date: Sunday, 22 October 2023.