The collaboration between Biocartis Group NV, a molecular diagnostics company, and APIS Assay Technologies, a private U.K.-based company specializing in molecular diagnostics, is expanding(1) to include the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ worldwide commercial network.

“We are excited to expand our partnership with APIS Assay Technologies to commercialize the APIS ESR1 Mutations Kit,” says Roger Moody, CEO of Biocartis. “Together with the IdyllaTM PIK3CA- AKT1 Mutation Assay and the APIS Breast Cancer Subtyping Kit we will be able to provide a comprehensive menu of products in the breast cancer domain to our customers. Our commercial team has been building a network within the breast cancer domain and we will be able not only to leverage it but also to further expand it by adding the APIS ESR1 Mutations Kit on our product portfolio.”

Breast cancer is the most common cancer diagnosed globally(2) 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.(3) Several mechanisms of resistance have been described, including mutations in the estrogen receptor (ESR1) gene.(4) ESR1 mutations are a common mechanism of endocrine resistance(5) are associated with a shorter progression-free survival.(6)

Further reading: Study Finds Reductions in Breast Cancer Screening During Pandemic

New therapeutic options are becoming available that have the potential to overcome ESR1 mutation-mediated resistance.(7) 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.

“We are very much looking forward to our further collaborations with the Biocartis team,” says Ian Kavanagh, CEO of APIS. “Biocartis’ global presence will allow a fast commercialisation and worldwide roll out of the APIS ESR1 Mutations Kit. As we are currently developing the APIS Breast Subtyping Cancer Kit on the IdyllaTM platform, our teams are already working closely together and are fully up-to-speed to enable a broader availability of our innovative breast cancer assay portfolio, as well as to explore the opportunity of also developing a fully automated version of the APIS ESR1 Mutations Kit on the IdyllaTM platform.”

The APIS ESR1 Mutations Kit is a qualitative, qPCR(10) 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. 

Featured image: The APIS ESR1 Mutation Kit. Photo: APIS


  1. The partnership between Biocartis NV and APIS was announced on 4 April 2023
  2. WHO Globocan;
  3. Colleoni et al. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol (2016) 34: 927-35
  4. Hartkopf et al. Endocrine-Resistant Breast Cancer: Mechanisms and Treatment. Breast Care (2020) 15: 347-54
  5. Brett et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. (2021) 23: 85
  6. Hernando et al. Oral Selective Estrogen Receptor Degraders (SERDs) as a Novel Breast Cancer Therapy: Present and Future from a Clinical Perspective. Int J Mol Sci (2021) 22: 7812
  7. Ferro et al. Oral selective estrogen receptor degraders (SERDs): The new emperors in breast cancer clinical practice? Semin Oncol (2023) 26: S0093
  8. Li et al. Clinical Implications of Monitoring ESR1 Mutations by Circulating Tumor DNA in Estrogen Receptor Positive Metastatic Breast Cancer: A Pilot Study. Transl Oncol (2020) 13: 321-28
  9. Zunderlevich et al. ESR1 mutations are frequent in newly diagnosed metastatic and loco-regional recurrence of endocrine-treated breast cancer and carry worse prognosis. Breast Cancer Res (2020) 22: 16
  10. PCR (Polymerase Chain Reaction)