Press release Biocartis Group NV: US Multicenter Study Shows Idylla™ Allows Rapid and Accurate Mutation Testing Results Across Different Laboratory Settings

PRESS RELEASE: 26 June 2020, 07:00 CEST

US Multicenter Study Shows Idylla™ Allows Rapid and Accurate Mutation Testing Results Across Different Laboratory Settings

Mechelen, Belgium, 26 June 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the publication of a new multicenter study¹ led by researchers from Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center (Lebanon, New Hampshire, US) in the ‘American Journal of Clinical Pathology’. The study showed that, compared to current standard-of-care testing methods, Biocartis’ molecular diagnostics platform Idylla™ can substantially improve turnaround time of the results of mutation testing, independent of the size of the laboratory.

The new multicenter study included 20 laboratories of different types and sizes throughout the US and Puerto Rico, and data from almost 800 colorectal cancer samples. Consequently, it is one of the largest studies performed involving Idylla™. Contrary to other studies that often research the assay (test) turnaround time, this study focused on the full sample journey, or the turnaround time between ordering the test and receiving the results, including steps such as sample transport to the laboratory, or pathologist sign off time. Researchers found that the average turnaround time for test results could be cut by more than 50% from 15 days to 5 days, with some results available in a single day, with Idylla™.

The study, using the Idylla™ KRAS Mutation Assay (RUO²) and the Idylla™ NRAS-BRAF Mutation Assay (RUO), also concluded that the simplicity and ease of use of Idylla™ compared with other molecular techniques make it suitable for integration into laboratories of any size, including those that may not have much molecular expertise. Finally, the study addressed the use of minimal tissue from the samples, showing that even smaller tissue-based specimens can be successfully analyzed by Idylla™.

Herman Verrelst, Chief Executive Officer of Biocartis, stated: “We are very pleased with this large new multicenter study focusing on the full sample journey. Results show that Idylla™ performs very strongly in terms of delivering highly accurate, rapid results, but also in terms of its simplicity, making Idylla™ suitable even for smaller laboratory settings.”

Gregory Tsongalis, PhD, HCLD, CC, Professor and Vice Chair of Research in the Department of Pathology and Laboratory Medicine at Dartmouth’s Geisel School of Medicine, reacted:“Our results are in line with findings of other studies showing successful analyses with Idylla™, using very small tissue amounts, including those deemed too small for standard molecular testing methods. Idylla™’s simplicity and ease of use compared with other molecular techniques make it suitable for routine laboratory testing.”

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More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
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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, with a focus 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 statements
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.

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¹ Tsongalis et al., “Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer”, Am J Clin Pathol. 2020 Jun 11;aqaa044. doi: 10.1093/ajcp/aqaa044. Online ahead of print.

² RUO = Research Use Only, not for use in diagnostic procedures

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