APIS Breast Cancer Subtyping Kit (RUO*)

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 tumor tissue.

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Description

The APIS Breast Cancer Subtyping Kit is a highly reproducible, RT-qPCR-based kit for detecting mRNA expression of standard breast cancer biomarkers (HER2, ER, PR, Ki67) and novel proliferative biomarkers from core-needle biopsy (CNB) or resected formalin-fixed paraffin embedded (FFPE) breast tumor tissue. Receptor tyrosine-protein kinase erbB-2 (HER2), oestrogen receptor (ER), progesterone receptor (PR), and marker of proliferation (Ki67) biomarkers play a key role in breast cancer.

The kit also includes a novel four-gene proliferative signature that comprises four markers (MKI67, CCNA2, KIF23, and PCNA) associated with proliferation. These markers are expressed throughout all cell cycle stages, providing a more precise representation of tumor proliferation.

*APIS Breast Cancer Subtyping Kit is for Research Use Only (RUO), not for use in diagnostic procedures.

Download Leaflet: APIS RUO – Leaflet – Sep2023

Specimen Requirements:

  • 10 µM FFPE core needle biopsy or resected tissue section
  • Neoplastic cells ≥20%

 

A Comprehensive Molecular Profile for Breast Cancer

The APIS Breast Cancer Subtyping Kit uses One Step RT-qPCR with dye-linked oligonucleotides to detect sequence amplification. To selectively amplify the mRNA sequence, at least one of the oligonucleotides used to generate the amplicon is spanning an exon-exon boundary. The probe binds to the target sequence between the primers.

APIS Breast Cancer Subtyping Kit Controls

The APIS Breast Cancer Subtyping Kit contains an internal control (IC), a synthetic RNA sequence, which monitors for assay set up, reagent performance and interfering substances. Positive and Negative Template Controls (PC and NTC), which monitor run validity and reagent performance, are also supplied with the kit.