Breast Cancer Assay Portfolio

An assay for the molecular characterization of hormone receptor positive (HR+) HER2 negative (HER2-) metastatic breast cancer. For Research Use Only.

The APIS Breast Cancer Subtyping Kit is a highly reproducible, RNA-based diagnostic workflow for detecting mRNA expression of standard biomarkers (ER, PR, HER2, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumour tissue.

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

A digital PCR (dPCR) workflow allowing for reliable detection of mutations within the oestrogen receptor (ESR1) gene. The kit detects eleven ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H, L536P, Y537C, Y537S, Y537N and D538G).

The APIS ESR1 Mutations Controls serve as a quality control material and can be used for oestrogen receptor gene (ESR1) mutations assay validations, or alongside the APIS ESR1 Mutations Kit as run validity controls. The product consists of two tubes, a negative and a positive control. The positive control contains DNA fragments encoding eleven mutations within the ESR1 gene, as well as a reference sequence encoding a fragment of exon 3.

The APIS PIK3CA Mutations Kit is a real-time qualitative PCR test for the detection of the five most prevalent activating mutations in the PIK3CA gene, using DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue (gDNA) or blood plasma (cfDNA).