Biocartis and APIS Expand Partnership in Breast Cancer with ESR1 Test Added to ASCO Guidelines in May
Biocartis, an oncology focused molecular diagnostics company, is expanding its partnership with APIS Assay Technologies. This expansion includes the commercialization of the APIS ESR1 Mutations Kit through Biocartis’ global commercial network. The APIS ESR1 Mutations Kit, a qualitative qPCR-based product for detecting ESR1 mutations in plasma samples. The kit will initially be available in Europe.
The companies are working to commercialize the kit on the IdyllaTM Platform, a fully-automated system for molecular testing using real-time PCR. It offers rapid results, and all necessary consumables are conveniently contained within a single cartridge, reducing handling time and the risk of contamination. Biocartis and APIS previously announced plans to create a breast cancer subtyping kit on the system.
ESR1 mutation testing is used in patients with Estrogen Receptor-positive (ER+) breast cancer, the common subtype, where endocrine therapy is a primary treatment option. Of the roughly 298,000 cases of breast cancer diagnosed in the U.S. every year, about 223,000 or 75% are estrogen receptor positive. Unfortunately, many tumors become resistant to endocrine therapy as the cancer progresses. One common mechanism of this resistance is the presence of mutations in the estrogen receptor (ESR1) gene. These mutations are associated with shorter progression-free survival. In May, the American Society of Clinical Oncology recommended ESR1 mutation testing for specific cases of metastatic breast cancer. Their guidelines suggest that patients with metastatic, estrogen receptor-positive breast cancers that exhibit growth or recurrence should undergo ESR1 mutation testing.