Press release Biocartis Group NV

Biocartis Honors Breast Cancer Awareness Month with Launch of Breast Cancer Portfolio

PRESS RELEASE 16 October 2023, 7:00 CEST

Biocartis Honors Breast Cancer Awareness Month with Launch of Breast Cancer Portfolio

Mechelen, Belgium, 16 October 2023 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces the launch of the new Breast Cancer Portfolio during the Breast Cancer Awareness month: the Idylla PIK3CA-AKT1 Mutation Assay and, in collaboration with APIS Assay Technologies (‘APIS’), the APIS Breast Cancer Subtyping Kit and the APIS ESR1 Mutations Kit.

The Idylla PIK3CA-AKT1 Mutation Assay (RUO¹), performed on the Biocartis Idylla Platform, is a fully automated real-time polymerase chain reaction (PCR) Assay for the qualitative detection of 13 mutations in the PIK3CA gene and one mutation in the AKT1 gene in formalin-fixed, paraffin-embedded (FFPE) human tissue sections. The Idylla PIK3CA- AKT1 Mutation Assay, which was developed in collaboration with LifeArc, covers the entire process from FFPE sample to result, including fully integrated sample preparation, liberation of nucleic acids, real-time PCR amplification and detection, and data analysis. With a turnaround time of approximately 150 minutes, the Assay provides a rapid actionable solution which can be seamlessly integrated into virtually any laboratory workflow.

The APIS Breast Cancer Subtyping Kit (RUO¹) is a gene expression assay based on a real-time reverse transcription quantitative polymerase chain reaction (RT-qPCR). The kit detects and enables relative gene expression quantification of ten human mRNA target genes extracted from formalin-fixed, paraffin embedded (FFPE) pre-operative core needle biopsies (CNB) or FFPE resected breast tumour tissue. The manual kit will be distributed by Biocartis in selected European countries ahead of an Idylla version of the assay becoming available. While the manual kit already offers a reduced time for results interpretation (as compared to current IHC² based workflows), the future Idylla version of the Breast Cancer Subtyping Assay will further benefit from the workflow and decentralization advantages of the Idylla Platform.

The APIS ESR1 Mutations Kit (RUO¹) is an advanced real-time PCR assay for the sensitive and precise detection of mutations within the estrogen receptor gene. The kit detects eleven ESR1 mutations in circulating free DNA from plasma samples. Biocartis will distribute the manual kit via its commercial network with an initial focus on Europe and will explore, together with APIS, the opportunity of also developing a fully automated version of the APIS ESR1 Mutations Kit on the Idylla Platform.