APIS Breast Cancer Subtyping Kit (IVD)

Understanding Breast Cancer Tumour Biology

Molecular subtyping is critical for therapy selection

Receptor tyrosine-protein kinase erbB-2 (HER2), oestrogen receptor (ER), progesterone receptor (PR), and marker of proliferation Ki67 expression plays a key role in breast cancer intrinsic subtype evaluation and guides treatment decisions.

The APIS Breast Cancer Subtyping Kit is an RNA-based diagnostic workflow for detecting mRNA expression of standard biomarkers (HER2, ER, PR, Ki67) and a novel proliferative signature from pre-operative core needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumour tissue. The test serves as an alternative method to current standard of care – immunohistochemistry (IHC).

The APIS Breast Cancer Subtyping Kit is an advanced assay for characterising breast cancer, providing fast and highly accurate results in less than 5 hours*

*when processing 10 samples

Automated Breast Cancer Subtyping Results Interpretation

Quick analysis using the automated APIS Breast Cancer Subtyping Kit Software, with the results available in seconds.

Gene-level nomenclature, HER2 = ERBB2, ER = ESR1, PR = PGR, Ki67 = MKI67

Clinical Performance Evaluation

The performance of the APIS Breast Cancer Subtyping Kit was assessed as an agreement with the current standard of care (IHC) using over 600 breast cancer CNB and resected specimens.

ER, PR and HER2

Concordance for ER, PR and HER2 Between APIS Breast Cancer Subtyping Kit and IHC-based Biomarker Assessment

Strong correlation to IHC with highly reproducible and accurate ER, PR and HER2 detection

Providing a single resolution method for HER2 detection with the opportunity to enhance HER2 stratification

Ki67 and Proliferative Signature

Concordance for Ki67 and Proliferative Signature Between APIS Breast Cancer Subtyping Kit and IHC-based Biomarker Assessment

Good correlation to IHC, with the novel proliferative signature supporting the use of Ki67 alone for measuring proliferation