APIS Breast Cancer Subtyping Kit (RUO*)
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 tumour 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 tumour proliferation.
*APIS Breast Cancer Subtyping Kit is distributed by Biocartis for Research Use Only (RUO), not for use in diagnostic procedures. Data and conclusions have not been validated by Biocartis NV.
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.
APIS Breast Cancer Subtyping Kit Performance
Comparison of APIS Breast Cancer Subtyping Kit expression measure (ΔCt) with IHC% nuclei staining for each target. A strong* correlation between IHC% staining and the APIS Breast Cancer Subtyping Kit can be observed.
Y axis; APIS RNA gene expression (ΔCt value) with assays cut-off (dashed line) indicating positive/negative calling. Cut off values valid only when analysis performed using QS5™Dx instrument. X axis; IHC positive nuclei (%).
*ER: R2 0.639; p <.0001 | PR: R2 0.633; p <.0001 | Ki67: R2 0.414; p <.0001 | Proliferation Signature: R2 0.475; p <.0001
