Press release Biocartis Group NV: Biocartis Announces Expansion of its Collaboration with APIS Assay Technologies to Commercialize the APIS ESR1 Mutations Kit

PRESS RELEASE 12 October 2023, 7:00 CEST

Biocartis Announces Expansion of its Collaboration with APIS Assay Technologies to Commercialize the APIS ESR1 Mutations Kit

Mechelen, Belgium, 12 October 2023 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company and APIS Assay Technologies Ltd. (‘APIS’), a private UK based company specializing in molecular diagnostics, today announced the expansion of their partnership¹ to include the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ worldwide commercial network.

Roger Moody, Chief Executive Officer of Biocartis, commented: “We are excited to expand our partnership with APIS Assay Technologies to commercialize the APIS ESR1 Mutations Kit. Together with the Idylla™ PIK3CA-AKT1 Mutation Assay and the APIS Breast Cancer Subtyping Kit we will be able to provide a comprehensive menu of products in the breast cancer domain to our customers. Our commercial team has been building a network within the breast cancer domain and we will be able to not only to leverage it but also to further expand it by adding the APIS ESR1 Mutations Kit on our product portfolio.”

Ian Kavanagh, Chief Executive Officer of APIS, added: “We are very much looking forward to our further collaborations with the Biocartis team. Biocartis’ global presence will allow a fast commercialization and worldwide roll out of the APIS ESR1 Mutations Kit. As we are currently developing the APIS Breast Cancer Subtyping Kit on the Idylla™ Platform, our teams are already working closely together and are fully up-to-speed to enable a broader availability of our innovative breast cancer assay portfolio, as well as to explore the opportunity of also developing a fully automated version of the APIS ESR1 Mutations Kit on the Idylla™ Platform.”

Breast cancer is the most common cancer diagnosed globally² and it is classified into different molecular subgroups according to hormone receptor and HER2 status. Estrogen Receptor-positive (ER+) breast cancer is the most common subtype of breast cancer and endocrine therapy is the main therapeutic option for this group. Most tumors, however, develop resistance to endocrine therapy as the cancer progresses.³ Several mechanisms of resistance have been described, including mutations in the estrogen receptor (ESR1) gene.⁴ ESR1 mutations are a common mechanism of endocrine resistance⁵ and are associated with a shorter progression-free survival⁶.

New therapeutic options are becoming available that have the potential to overcome ESR1 mutation-mediated resistance.⁷ ESR1 mutation monitoring has the potential for playing a key role in monitoring disease progression and appearance of resistance in breast cancer patients receiving endocrine therapy.^8,9 Further research is, however, needed to better understand the potential value of ESR1 mutation monitoring.

The APIS ESR1 Mutations Kit is a qualitative, qPCR¹⁰ based, Research Use Only (RUO) product for the detection of ESR1 mutations in plasma samples. Biocartis will distribute the kit via its commercial network with an initial focus on Europe.

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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 and liver cancer, as well as for sepsis. More information: www.biocartis.com. Follow us on X (Twitter): @Biocartis_.

About APIS

APIS is leveraging systems biology, interrogating multi-OMICs biodata, and deploying innovative ‘Clickmer’ ligand binding technology, for the validation and translation of biomarker and therapeutic assets into clinical utility. APIS has deep expertise and capabilities in IVD development of molecular & immune assays for ultimate product realization as diagnostic tests. In addition, APIS' expertise in bioinformatics and software development is offered as an agile service to our clients, to develop bespoke, end-to-end multi-OMICs solutions and platform development. The new APIS ESR1 Mutations Kit is an advanced qPCR based RUO product for the sensitive and precise detection of mutations within the estrogen receptor gene. The ESR1 Mutations Kit is a qualitative test, detecting eleven ESR1 mutations across three exons. It is applicable for use in both centralized and decentralized settings, especially for those facilities that require a testing solution without the need for additional specialised NGS or digital PCR instruments. For more information, visit https://www.apisassay.com/, or follow APIS on X (Twitter) @ApisAssay or LinkedIn.

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 The partnership between Biocartis NV and APIS was announced on 4 April 2023
² WHO Globocan; https://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf
³ Colleoni et al. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol (2016) 34: 927-35
⁴ Hartkopf et al. Endocrine-Resistant Breast Cancer: Mechanisms and Treatment. Breast Care (2020) 15: 347-54
⁵ Brett et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. (2021) 23: 85
⁶ Hernando et al. Oral Selective Estrogen Receptor Degraders (SERDs) as a Novel Breast Cancer Therapy: Present and Future from a Clinical Perspective. Int J Mol Sci (2021) 22: 7812
⁷ Ferro et al. Oral selective estrogen receptor degraders (SERDs): The new emperors in breast cancer clinical practice? Semin Oncol (2023) 26: S0093
⁸ Li et al. Clinical Implications of Monitoring ESR1 Mutations by Circulating Tumor DNA in Estrogen Receptor Positive Metastatic Breast Cancer: A Pilot Study. Transl Oncol (2020) 13: 321-28
⁹ Zunderlevich et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res (2020) 22: 16
¹⁰ PCR (Polymerase Chain Reaction)