Biocartis Idylla PIK3CA-AKT1 Mutation Assay, APIS Breast Cancer Subtyping Kit, APIS ESR1 Mutations Kit

Biocartis has launched a new portfolio of research-use-only breast cancer tests including the Idylla PIK3CA-AKT1 mutation assay and, in collaboration with APIS Assay Technologies, the APIS Breast Cancer Subtyping Kit and APIS ESR1 Mutations Kit.

The Idylla PIK3CA-AKT1 Mutation Assay is a fully automated real-time PCR test performed on the Biocartis Idylla platform for the qualitative detection of 13 mutations in the PIK3CA gene, plus one mutation in the AKT1 gene in FFPE human tissue sections. It has a turnaround time of approximately 150 minutes.

The APIS Breast Cancer Subtyping Kit is an RT-qPCR gene expression assay that enables relative gene expression quantification of 10 human mRNA target genes extracted from FFPE pre-operative core needle biopsies or resected breast tumor tissue. Biocartis will distribute the manual kit in selected European countries ahead of a planned Idylla version.

The APIS ESR1 Mutations Kit is designed to detect 11 ESR1 mutations in circulating DNA from plasma samples. Biocartis will also distribute this manual kit initially in Europe and will explore, together with APIS, the development of a fully automated version on Idylla.