Breast Cancer Subtyping Assay on Rapid MDx Platform to Deliver Fastest Time to Results

7% of all cancer cases globally, is the most frequently diagnosed cancer among women. As of 2020, more than 2.2 million new cases of breast cancer were estimated to occur worldwide. Invasive breast cancer is classified into different categories based on tumor behavior and prognosis. The main molecular subtypes of invasive breast cancer can be identified by examining the presence of hormone receptors (HER2, ER, PR) and a proliferation marker (Ki67) in breast cancer cells. These markers serve as a guide for selecting the most appropriate treatment options. ER and PR are key markers used to predict the effectiveness of hormone therapy for breast cancer. In contrast, HER2 is a critical indicator for targeted therapies like trastuzumab. The identification of these markers is typically done through immunohistochemistry screening (IHC). Now, a new collaboration will provide the ability to perform breast cancer subtyping analysis directly in pathology labs utilizing a molecular diagnostics platform capable of delivering the fastest time to results.

Biocartis Group NV (Mechelen, Belgium) and APIS Assay Technologies Ltd. (Manchester, UK) have entered into a new partnership agreement for the development of APIS’ Breast Cancer Subtyping assay on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla. Based on the terms of their agreement, APIS will lead the development of the Breast Cancer Subtyping test on Idylla, while Biocartis will be in charge of the commercialization via its expanding Idylla network.

APIS’ current Breast Cancer Subtyping Kit is an RNA-based diagnostic assay designed to detect mRNA expression of standard biomarkers (HER2, ER, PR, Ki67), as well as novel proliferative biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed paraffin-embedded (FFPE) breast tumor tissue. The kit is intended to address several unmet needs in current practice, such as enhancing reproducibility and accuracy in measuring Ki67 proliferation, and evaluating low HER2 expression status. This is particularly crucial since recent studies have demonstrated that HER2-low patients are responsive to a new class of HER2 targeting therapies.

At present, the APIS Breast Cancer Subtyping Kit is available as a manual kit for in vitro diagnostic use and mainly targets centralized expert laboratories in the UK. Biocartis will soon commercialize the kit on a broader scale ahead of the availability of the Idylla version of the assay. Although the manual kit already offers a shorter time for results interpretation than current IHC-based workflows, the Idylla version is expected to benefit from the workflow and decentralization advantages of the Idylla platform. This is expected to enable the fastest time to results and enhance access to the most accurate biomarker results for patients worldwide.

“We are excited about partnering with APIS Assay Technologies to improve molecular classification for breast cancer patients,” said Herman Verrelst, Chief Executive Officer of Biocartis. “The APIS team is highly experienced in IVD development and will lead the porting of the assay to our Idylla platform. Our sales team has become highly proficient in distribution of manual kits across its extensive laboratory network, while developing Idylla version of partner assays. The combination of the APIS Breast Cancer Subtyping test with the Idylla PIK3CA-AKT1 Mutation Assay that is under development will allow us to offer a complementary set of assays in the breast cancer domain.”

“We are very much looking forward to our collaboration with the Biocartis team,” added Joachim Schorr, Chief Executive Officer of APIS Assay Technologies. “The Idylla platform and its all-in-one cartridge-based tests provide an optimized, fully automated solution for fast and effective treatment selection for breast cancer patients. Furthermore, Biocartis’ global presence will further allow our innovative solution to benefit breast cancer patients worldwide. The collaboration with Biocartis will provide the ability to perform Breast Cancer Subtyping analysis also directly in pathology labs utilizing the Idylla platform’s ease of use and integrated FFPE sample-to-result performance.”

Related Links:
Biocartis Group NV 
APIS Assay Technologies Ltd.