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.