The agreement covers an ESR1 mutation detection kit for metastatic breast cancer and a DPYD genotyping kit for assessing chemotherapy toxicity risk.


BIOTYPE and APIS Assay Technologies have entered a commercial partnership to bring two molecular testing solutions to market under BIOTYPE’s ExaccType brand: the ExaccType ESR1 dPCR Kit and the ExaccType DPYD Kit.

The partnership builds on APIS’s molecular assay technologies to address clinical applications in precision medicine, specifically ESR1 mutation detection in metastatic breast cancer and DPYD genotyping to evaluate genetic factors associated with fluoropyrimidine toxicity risks.

The ExaccType ESR1 dPCR Kit uses digital PCR (dPCR) technology to detect key ESR1 mutations associated with acquired resistance to endocrine therapy in hormone receptor-positive, HER2-negative metastatic breast cancer. Meanwhile, the ExaccType DPYD Kit enables the detection of relevant DPYD genetic variants linked to an increased risk of severe toxicity from fluoropyrimidine-based chemotherapy, supporting clinical efforts to enhance the safety of cancer treatments.

“We are pleased to partner with BIOTYPE to bring our ESR1 mutation detection and DPYD testing solutions to a broader market,” says Dr Ian Kavanagh, CEO of APIS, in a release. “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.”

Expanding Oncology and Pharmacogenetics Portfolios

Under the agreement, BIOTYPE will commercialize both assays to expand its diagnostic menu in oncology and pharmacogenetics, while APIS extends the commercial footprint of its molecular testing portfolio.

“Expanding our portfolio with these molecular testing solutions is an important step in strengthening our offering in oncology and pharmacogenetics,” says Dr Timm Zörgiebel, BIOTYPE CEO, in a release. “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.”

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