BCART Biocartis Group NV

PRESS RELEASE: 8 February 2022, 07:00 CET

Biocartis and Ophiomics to Collaborate on Liver Cancer Test

• Primary liver cancer1 is the sixth most common and third most lethal cancer in the world
• Collaboration to focus on commercialization of HepatoPredict™, a prognostic gene expression signature test to identify which patients will benefit from liver transplantation

Mechelen, Belgium, 8 February 2022 - Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), and Ophiomics, a Lisbon (Portugal) based biotech company developing a precision medicine portfolio focused on liver cancer, today announce that they entered into a collaboration which will initially focus on the commercialization of HepatoPredict™, a prognostic gene expression signature test to help identify which patients will benefit from curative-intent surgery, in particular liver transplantation. HepatoPredict™ will be distributed by Biocartis in Europe as a manual kit mainly addressing centralized expert laboratories, and the test may later be translated into a version on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™.

Primary liver cancer is the sixth most common and third most lethal cancer in the world, with more than 900,000 new cases per year resulting in more than 800,000 deaths per year2. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer that frequently occurs in people with chronic liver diseases, such as cirrhosis3. Treatment options include ablation4, surgical resection5 or transplantation, with liver transplant being the most effective curative treatment for HCC patients with cirrhosis6. Due to shortage of donor organs, the proper selection of patients is crucial. Current models to select patients are sub-optimal7, leading to potential exclusion of patients that may benefit from surgery.

HepatoPredict™ is a gene expression signature test that combines clinical parameters with molecular markers to assess the tumor biology, aiming to predict which patients will benefit most from liver transplant and identifying those for which a transplant should be avoided. HepatoPredict™ has been validated retrospectively with encouraging results, increasing the number of patients that can benefit from curative-intent transplantation by 32%8. Further prospective and retrospective validation is ongoing9. HepatoPredict™ will be launched as a CE-marked IVD manual kit in Q1 2022. The partnership will initially focus on Biocartis’ commercialization of the manual kit in Europe. In a next stage, depending on successful commercial uptake of the manual kit, Ophiomics and Biocartis aim to initiate the development of a fully automated version of the test on Biocartis’ decentralized Idylla™ platform.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are excited to partner with Ophiomics to improve outcomes for liver cancer patients. The availability of a manual kit version of the Ophiomics test allows us to help patients and generate commercial traction right from the start of the collaboration while we prepare to bring this test onto our Idylla™ platform to maximize patient access to the test long term.”

José Pereira Leal, Chief Executive Officer of Ophiomics, added: “We are thrilled to be initiating this collaboration with a company that is complementary to Ophiomics’ vision to develop effective precision medicine solutions that enable patients and healthcare providers to make the best treatment decisions. This partnership will enable us to immediately leverage Biocartis’ commercial organization for an early access to the European market, anticipating future, closer collaboration on this and other assays.”

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More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-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_.

About Ophiomics

Ophiomics is a biotech company developing new products and services integrating machine learning and genomics in support of diagnostic, prognostic, pharmacogenomics, and clinical follow up in liver cancer. Ophiomics is based in Lisbon, Portugal, at the LISPOLIS incubator, close to multiple small and large companies focusing on human health technologies. Ophiomics was founded and is managed by José Leal and Joana Vaz, specialists in Bioinformatics and in Genomics, respectively. They have worked together for close to a decade, as academic researchers, establishing a clinical services laboratory focusing on oncogenomics, and now developing the next generation of products that will disrupt the way we manage liver cancer. More information: www.ophiomics.com.

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 Primary liver cancer is a cancer that starts in the liver, in contrast to secondary liver cancer where the liver tumors are the result of metastasis from a primary tumor elsewhere in the patient2 Source: Globocan 20203 Cirrhosis is a late-stage liver disease that is characterized by fibrosis (scarring) of the liver tissue. Main causes include alcoholic liver disease (resulting from long term alcohol overconsumption), non-alcoholic steatohepatitis (NASH; linked to obesity and type 2 diabetes) and chronic hepatitis B or hepatitis C infection4 Ablation removes or destroys diseased tissue, for instance by using high temperature treatment5 In a partial hepatectomy the diseased section of the liver is removed. The remaining part of the liver may regrow, although with a reduced liver function6 Dhir M, Melin AA, Douaiher J, et al. A Review and Update of Treatment Options and Controversies in the Management of Hepatocellular Carcinoma. Annals of Surgery. 2016;263:1112–11257 Currently used selection models rely on clinical morphological models (e.g. Milan criteria: Mazzaferro et al., N Engl J Med (1996) 334:693-700 or San Francisco criteria: Yao et al., Hepatology (2001) 33:1394-40)8 Over Milan criteria, with a disease-free survival rate of 89%, or 94% when used in highest precision model. Source: Pinto-Marques et al. Submitted for publication. HepatoPredict improves current expanded selection models with precisions ranging between 53% and 84,5% while providing a clear, reproducible, objective prognosis in a few days. Source: Pavel M-C, Fuster J. Expansion of the hepatocellular carcinoma Milan criteria in liver transplantation: Future directions. WJG. 2018;24:3626–36369 ClinicalTrials.gov identifier: NCT04499833

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