Press release Biocartis Group NV: Biocartis Announces Launch of its Rapid CE-marked IVD Idylla™ GeneFusion Panel for Fast Treatment Decisions in Lung Cancer

2022年06月20日13:00

PRESS RELEASE: 20 June 2022, 07:00 CEST

Biocartis Announces Launch ofits Rapid CE-marked IVD Idylla™ GeneFusion PanelforFastTreatment Decisions in Lung Cancer

  • Idylla™ GeneFusion Panel available as rapid CE-marked IVD lung cancer testing solution for laboratories, with results within 180 minutes
  • 10% to 20% of advanced lung cancer patients don’t receive the appropriate targeted therapy due to slow turnaround time of many current testing methods, leading to a delayedtime-to-treatment1

Mechelen, Belgium, 20 June 2022 Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), announces the CE-marking of its fully automated Idylla™ GeneFusion Panel (CE-IVD). The Panel detects in one single cartridge ALK, ROS1, RET and METex14 skipping, a wide range of actionable targets relevant in non-small cell lung cancer (NSCLC). Designed for use in clinical laboratories, the Panel provides comprehensive testing results within 180 minutes, significantly faster than currently available testing methods which often take days or even weeks before results are available.

Lung cancer remains the leading cause of cancer deaths, with NSCLC being the most common type of lung cancer. The survival rate has increased over the past years due to the rapidly evolving treatment landscape for NSCLC. Gene fusions represent an important class of gene rearrangements and have become important in NSCLC, as they are linked to responses to certain targeted therapies. Their accurate and fast detection is critical to guide therapy choices, which is the reason why testing for gene rearrangements such as gene fusions is included in international NSCLC testing guidelines (including ESMO and NCCN).

However, comprehensive testing of actionable gene rearrangements in NSCLC is often complex and can require different technologies2. In order to test all needed biomarkers, laboratories usually have to use different instruments which are often not available within their own lab. Using different instruments also requires having enough biopsy samples of sufficient good quality, which can be difficult to obtain, especially in NSCLC patients.

Commenting on the launch of the Idylla™ GeneFusion Panel, Herman Verrelst, Chief Executive Officer of Biocartis, said:Turnaround time and time-to-treatmentremains an important barrier to molecular testing. It has been demonstrated that 10% to 20% of advanced lung cancer patients do not receive the appropriate targeted therapy because biomarker results are not provided in a timely fashion1. With the CE-marked IVD of the Idylla™ GeneFusion Panel, laboratories will have a rapid actionable and in-house solution at their disposal which can be seamlessly integrated into virtually any laboratory workflow.

The Idylla™ GeneFusion Panel consolidates traditional testing workflows into one streamlined, fully-automated process which provides reliable information on ALK, ROS1, RET and METex14 skipping and delivers results within 180 minutes. Moreover, the Panel only requires a limited amount of sample, thereby saving valuable tissue specimens. The Idylla™ GeneFusion Panel demonstrated high concordance results in a clinical comparison study where ALK was compared with IHC, and ROS1, RET and METex14 skipping were compared with NGS3.

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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

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, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for COVID-19, flu, RSV and sepsis. 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. 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.

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.

1 Finall et al. Integration of rapid PCR testing as an adjunct to NGS in diagnostic pathology services within the UK: evidence from a case series of non-squamous, non-small cell lung cancer (NSCLC) patients with follow-up? J Clin Pathol. 5 Jan 2022 Chu et al. Clinical Utility and Performance of an Ultrarapid Multiplex RNA-Based Assay for Detection of ALK, ROS1, RET, and NTRK1/2/3 Rearrangements and MET Exon 14 Skipping Alterations. J Mol Diagn. 2022 Apr

2 I.e. gene fusions and METex14 skipping. Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse-transcriptase PCR (RT-PCR), fluorescence in situ hybridisation (FISH), and immunohistochemistry (IHC). Source: OncologyPro, ESMO, see here, last consulted on 2 June 2022

3 Data obtained from the clinical performance evaluation performed by Biocartis in view of the CE-marking. The clinical performance evaluation compared the Idylla™ GeneFusion Panel with IHC (VENTANA ALK (D5F3) Assay, Roche Diagnostics GmbH) for ALK; ROS1, RET and METex14 skipping were evaluated versus NGS (Oncomine™ Focus Assay, Thermo Fisher Scientific)

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