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Biocartis, Apis Assay Technologies to Develop Breast Cancer Subtyping Test

NEW YORK – Biocartis and Apis Assay Technologies announced on Tuesday that they have entered into a partnership agreement to develop and commercialize Apis' Breast Cancer Subtyping assay on Biocartis' Idylla platform. 

Manchester, UK-based Apis will lead the development of the test on the molecular diagnostic platform, and Biocartis will lead commercialization efforts through its existing Idylla network, the companies said in a statement.

The Apis test is an RNA-based assay that detects mRNA expression of both standard biomarkers — HER2, ER, PR, and Ki67 — and novel proliferative biomarkers from preoperative core-needle biopsy or resected formalin-fixed paraffin-embedded breast tumor tissue. The assay is being developed to improve reproducibility and accuracy in Ki67 proliferation measurement and assessment of low HER2 expression status, the firms said.

The test is currently available as a manual kit for in vitro diagnostic use, mainly for centralized laboratories, and is offered by Apis in the UK. Mechelen, Belgium-based Biocartis will broadly commercialize the test before the Idylla version becomes available, the companies said. 

Financial and other terms of the agreement were not disclosed.

"The Idylla platform and its all-in-one cartridge-based tests provide an optimized, fully automated solution for fast and effective treatment selection for breast cancer patients," Apis CEO Joachim Schorr said in a statement. "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 utilizing the Idylla platform’s ease of use and integrated FFPE sample-to-result performance," Schorr added.