APIS Assay Technologies
APIS, a private UK based company specializing in molecular diagnostics, is leveraging systems biology, interrogating multi-OMICs biodata, and deploying innovative ‘Clickmer’ ligand binding technology, for the validation and translation of biomarker and therapeutic assets into clinical utility. APIS has deep expertise and capabilities in IVD development of molecular & immune-assays for ultimate product realisation as diagnostic tests.
APIS Assay Technologies and Biocartis announced their partnership agreement on 4 April 2023, which targets the development of APIS Breast Cancer Subtyping Kit on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™.
Breast cancer
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 worldwide1 .
Invasive breast cancer is classified into distinct categories with differing tumour behaviour and prognosis2 . Based on the expression of hormone receptors that are present in breast cancer cells (HER2, ER, PR)3 and a proliferation marker (Ki67)4 , the main molecular subtypes of invasive breast cancer can be distinguished5. 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 trastuzumab6. The detection of these markers is routinely performed with IHC7 .
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 progresses8. Several mechanisms of resistance have been described, including mutations in the estrogen receptor (ESR1) gene9. ESR1 mutations are a common mechanism of endocrine resistance10 and are associated with a shorter progression-free survival11.
13th St. Gallen International Breast Cancer Conference 2013, Expert panel consensus opinion
ER: estrogen receptor, PR: progesterone receptor, HER2: human epidermal growth factor receptor 2
Ki67: marker of proliferation Ki-67
Four main molecular subtypes: Luminal A, Luminal B, HER2, and Basal-like (triple negative)
Trastuzumab, sold among others under the brand name Herceptin®, is a monoclonal antibody used to treat HER2-positive breast cancer
IHC or Immunohistochemistry is a laboratory method that uses antibodies to check for certain antigens (markers) in a sample of tissue. Source: https://www.cancer.gov/
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
Hartkopf et al. Endocrine-Resistant Breast Cancer: Mechanisms and Treatment. Breast Care (2020) 15: 347-54
Brett et al. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. (2021) 23: 85
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
APIS Breast Cancer Subtyping Kit
The APIS Breast Cancer Subtyping Kit is a highly reproducible, RT-qPCR-based kit for detecting mRNA expression of standard breast cancer biomarkers (HER2, ER, PR, Ki67) and novel proliferative biomarkers.
APIS Breast Cancer Subtyping Kit is for Research Use Only (RUO), not for use in diagnostic procedures.
APIS ESR1 Mutations Kit
The APIS ESR1 Mutations Kit is an advanced qPCR assay for the sensitive and precise detection of mutations within the oestrogen receptor gene. The APIS ESR1 Mutations Kit is a qualitative test, detecting eleven ESR1 mutations across three exons: exon 5 (E380Q), exon 7 (S463P) and exon 8 (P535H, L536R, L536Q, L536H, L536P, Y537C, Y537S, Y537N and D538G).
The APIS ESR1 Mutations Kit includes mutation-specific probes to enable highly sensitive detection of the target mutations. Additionally, it uses PCR clamp and blocker technology, which ensures specific amplification of the mutant sequence, even in the presence of a high wild-type background.
APIS ESR1 Mutations Kit is for Research Use Only (RUO), not for use in diagnostic procedures.
WHAT OUR PARTNER SAYS ABOUT THE COLLABORATION
“We are very much looking forward to our collaboration with the Biocartis team. The Idylla™ Platform and its all-in-one cartridge-based tests provide an optimised, 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 utilising the Idylla™ Platform’s ease of use and integrated sample-to-result performance on FFPE samples.”
Joachim Schorr, Executive Chair of the Board of APIS Assay Technologies
