Biocartis Group NV announced expansion of its collaboration with APIS Assay Technologies Ltd. to commercialize the APIS ESR1 Mutations Kit. Breast cancer is the most common cancer diagnosed globally2 and it is classified into different molecular subgroups according to hormone receptor and HER2 status. Estrogen Receptor-positive (ER+) breast cancer is the most common subtype of breast cancer and endocrine therapy is the main therapeutic option for this group.

Most tumors, however, develop resistance to endocrine therapy as the cancer progresses. Several mechanisms of resistance have been described, including mutations in the estrogen receptor (ESR1) gene.ESR1 mutations are a common mechanism of endocrine resistance5 and are associated with a shorter progression-free survival. New therapeutic options are becoming available that have the potential to overcome ESR1 mutation-mediated resistance.ESR1 mutation monitoring has the potential for playing a key role in monitoring disease progression and appearance of resistance in breast cancer patients receiving endocrine therapy.8,9 Further research is, however, needed to better understand the potential value of ESR1 mutation monitoring.

The APIS ESR1 Mutations Kit is a qualitative, qPCR10 based, Research Use Only (RUO) product for the detection of ESR1 mutations in plasma samples. Biocartis will distribute the kit via its commercial network with an initial focus on Europe.