The Idylla PIK3CA-AKT1 Mutation Assay, 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 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.

 

The APIS Breast Cancer Subtyping Kit (RUO) is a gene expression assay based on a real-time reverse transcription polymerase chain reaction (RT-qPCR). The kit detects and enables relative gene expression quantification of standard biomarkers (HER2, ER, PR, Ki67) and a novel proliferative signature from pre-operative core needle biopsies (CNB) or FFPE resected breast tumour tissue.

 

The APIS ESR1 Mutations Kit (RUO) is an advanced real-time PCR assay for the sensitive and precise detection of mutations within the estrogen receptor gene. The APIS ESR1 Mutations Kit is a qualitative test, detecting 11 ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H L536P, Y537C, Y537S, Y537N and D538G).