Press news Biocartis Group NV: Biocartis Receives EUR 1.2 million Grant for Development of Highly Innovative Idylla™ GeneFusion Assay

Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that it has received a EUR 1.2 million grant from VLAIO, the Flanders organization for Innovation Entrepreneurship, for the development of the highly innovative GeneFusion Assay on its easy, rapid molecular and fully automated diagnostics platform Idylla™.

The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and will be the first FFPE1 RNA2-based assay on the Idylla™ platform. The Idylla™ GeneFusion Assay is expected to bring results in approx. 3 hours, with less than 2 minutes hands-on time. The VLAIO grant is intended to support the development of the GeneFusion Assay on the Idylla™ platform, and to support related research studies on different sample and tumor tissue types, including on lung cancer tissue.

Lung cancer is the most common cause of cancer-related deaths worldwide (27%) with 1.7 million deaths annually3. Clinical non-small cell lung cancer (NSCLC) guidelines4 recommend testing for amongst others EGFR mutations5. Today, gene fusions represent an increasingly important biomarker test category6. Although detected in a small portion of NSCLCs, testing for these gene fusions is important for the identification of patients who may benefit from different fusion gene targeted therapies, which show high response rates and long disease control upon treatment7. Current testing methods however are cumbersome because different technologies8 are needed to test all required biomarkers. Additionally, sample quantity and quality to perform all these tests are commonly suboptimal. Due to these complexities, time to results can be delayed, which can lead to inappropriate treatment decisions.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very pleased to receive this VLAIO grant and support from the Flemish government for highly innovative projects such as our GeneFusion Assay project. In the area of lung cancer testing, there is a clear unmet diagnostic need for comprehensive and fast molecular testing solutions that are compatible with a limited amount of sample. Together with the existing Idylla™ EGFR Mutation Test (CE-IVD), a key test in our lung cancer menu, the Idylla™ GeneFusion Assay (RUO9) is expected to offer our customers-laboratories a comprehensive testing solution for molecular biomarkers in this area, without the need for different instruments, and covering the majority of clinical guideline-recommended biomarkers.”

Biocartis expects to launch its Idylla™ GeneFusion Assay as a Research Use Only (RUO) assay in Q1 2021. Validation and release of an IVD version for use in NSCLC is also anticipated.

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More information: Renate DegraveHead of Corporate Communications Investor Relations Biocartise-mail rdegrave@biocartis.comtel +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. 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 Formalin fixed, paraffin embedded

2 Rubonucleic Acid. RNA is one of the three major biological macromolecules that are essential for all known forms of life (along with DNA and proteins)

3 Despite advances in early detection and treatment, most patients are diagnosed at an advanced stage and have a poor prognosis, with an overall 5-year survival rate of approx. 15%. Source: Kim E.S., Roy U.B., Ersek J.L., King J., Smith R.A., Martin N., Martins R., Moore A., Silvestri G.A., Jett J., 2019, Updates regarding biomarker testing for non-small cell lung cancer: considerations from the National Lung Cancer Roundtable

4 CAP/IASLC/AMP: College of American Pathologists/ International Association for the study of lung cancer/ Association for Molecular Pathology

5 And for ALK fusions, ROS1 fusions and BRAF mutations

6 One of the best-characterized examples is the fusion of EML4 and ALK genes, which is also the most prevalent fusion occurring in about 5% of NSCLCs

7 Villalobos P., Wistuba I.I, 2018, Lung cancer biomarkers. See also https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/targeted-therapies.html, last consulted on 24 September 2020. Peters et al, N Engl J Med 2017 377:829-838; Hong et al, Lancet Oncol 2020 21(4):531-540; Drilon et al N Engl J Med 2020; 383:813-824

8 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 23 September 2020

9 Not for use in diagnostic procedures