Collaboration Expands Access to Tests for Cancer Treatment Resistance and Toxicity Risk

In hormone receptor-positive, HER2-negative metastatic breast cancer, ESR1 mutations are associated with acquired resistance to endocrine therapy, while DPYD variants can indicate increased risk of severe toxicity from fluoropyrimidine-based chemotherapy.

APIS Assay Technologies (Manchester, UK) and BIOTYPE (Dresden, Germany) have entered a commercial partnership to bring the ExaccType ESR1 dPCR Kit and the ExaccType DPYD Kit to market under BIOTYPE’s ExaccType brand. Built on APIS’s established molecular assay technologies, both assays will be commercialized by BIOTYPE. This arrangement will expand BIOTYPE’s oncology and pharmacogenetics offering while extending the commercial reach of APIS’s molecular testing portfolio.

The two kits address distinct aspects of cancer treatment. The ExaccType ESR1 dPCR Kit uses digital PCR technology to detect key ESR1 mutations associated with acquired resistance to endocrine therapy in hormone receptor-positive, HER2-negative metastatic breast cancer. The ExaccType DPYD Kit detects relevant DPYD genetic variants associated with an increased risk of severe toxicity from fluoropyrimidine-based chemotherapy, supporting efforts to improve cancer treatment safety.

The collaboration builds on the companies’ complementary capabilities and creates opportunities for both to strengthen their presence in molecular diagnostics. BIOTYPE offers molecular precision diagnostics products and services for analyzing and interpreting clinical biomarkers, with applications in hemato-oncology, liquid biopsy, and molecular profiling of solid tumors. APIS contributes biomarker products and services, supported by capabilities in in vitro diagnostic development, bioinformatics, software, systems biology, multi-OMICs.

“We are pleased to partner with BIOTYPE to bring our ESR1 mutation detection and DPYD testing solutions to a broaderomics market. This collaboration reflects our commitment to working with established industry partners to extend the reach of our portfolio. We look forward to building a strong and productive relationship with the BIOTYPE team,” said Dr. Ian Kavanagh, Chief Executive Officer of APIS.

“Expanding our portfolio with these molecular testing solutions is an important step in strengthening our offering in oncology and pharmacogenetics. Working with APIS allows us to introduce additional high-quality testing options to our customers. We look forward to developing this partnership and continuing to expand our molecular diagnostics portfolio,” added Dr. Timm Zörgiebel, BIOTYPE CEO.

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