Biocartis Group NV and APIS Assay Technologies Ltd. announced that they have entered into a new partnership agreement which targets the development of APIS' Breast Cancer Subtyping assay on Biocartis' rapid and easy-to-use molecular diagnostics platform Idylla™. Under the terms of the partnership agreement, APIS will lead the development of the Breast Cancer Subtyping test on Idylla™, while Biocartis will lead the commercialisation through its growing Idylla™ network. Breast cancer is the most commonly diagnosed cancer among women, accounting for 11.7% of all cancer cases globally.

In 2020, it was estimated that there were over 2.2 million new cases of breast cancer worldwide. Invasive breast cancer is classified into distinct categories with differing tumour behaviour and prognosis. Based on the expression of hormone receptors that are present in breast cancer cells (HER2, ER, PR) and a proliferation marker (Ki67), the main molecular subtypes of invasive breast cancer can be distinguished.

The presence or absence of these markers can guide the selection of appropriate treatment options. ER and PR are important indicators of how well a breast cancer tumour will respond to hormone therapy. HER2, on the other hand, is an important predictor of response to targeted therapy, such as trastuzumab.

The detection of these markers is routinely performed with IHC. APIS' current Breast Cancer Subtyping Kit is an RNA-based diagnostic assay for detecting mRNA expression of standard biomarkers (HER2, ER, PR, Ki67) and novel proliferative biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumour tissue. The test aims to address a number of unmet needs in current practice, including improving reproducibility and accuracy in the Ki67 proliferation measurement and assessment of low HER2 expression status.

The latter is especially important as recent studies have shown HER2-low patients to be responsive to a new category of HER2 targeting therapies. Currently, the APIS Breast Cancer Subtyping Kit is available as a manual kit for in vitro diagnostic use, mainly addressing centralized expert laboratories. The kit is currently offered by APIS in the UK and will be broadly commercialised by Biocartis ahead of the Idylla™ version of the assay becoming available.

While the manual kit already offers a reduced time for results interpretation (as compared to current IHC based workflows), the Idylla™ version of the Breast Cancer Subtyping assay will further benefit from the workflow and decentralization advantages of the Idylla™ platform. This is expected to allow for the fastest time to results and for improved access to the most accurate biomarker results for patients worldwide.