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ROLLE, Switzerland & BELFAST, Northern Ireland, Monday, June 1, 2026 — SOPHiA GENETICS today announced the signing of a Master Collaboration Agreement with ARC Regulatory, a clinical research and regulatory compliance solutions partner specializing in IVDR and Clinical Performance Studies (CPS) as well as operating an EU & UK Health Institution laboratory.
The collaboration establishes a framework in which the two companies can provide genomic testing and regulatory support to pharmaceutical sponsors, combining SOPHiA GENETICS's global AI-based analytics platform and NGS applications with ARC's deep European regulatory expertise.
ARC Regulatory has launched a CAP-accredited and ISO15189 certified laboratory in Belfast, designated as an EU and UK health institution for genomic and molecular testing and is in the process of implementing MSK-IMPACT Flex® powered with SOPHiA DDMTM, SOPHiA GENETICS's world-class Solid Tumor application for Comprehensive Genomic Profiling.
Together, the two organisations will support Pharma companies with a streamlined offering from study design through clinical execution. Under the agreement, SOPHiA GENETICS and ARC will highlight the significant opportunity of the partnership, providing the sector with a trusted platform to support diagnosis, treatment and decision making.
Beyond clinical trial support, the partnership is designed as a strategic foundation for diagnostic development opportunities in the EU, with the aim of supporting Pharma partners from clinical discovery through to regulatory submission — and ultimately, to commercial launch.
SOPHiA GENETICS products are for Research Use Only and not for use in diagnostic procedures unless specified otherwise.
SOPHiA DDM™ Dx Hereditary Cancer Solution, SOPHiA DDM™ Dx RNAtarget Oncology Solution and SOPHiA DDM™ Dx Homologous Recombination Deficiency Solution are available as CE-IVD products for In Vitro Diagnostic Use in the European Economic Area (EEA), the United Kingdom and Switzerland. SOPHiA DDM™ Dx Myeloid Solution and SOPHiA DDM™ Dx Solid Tumor Solution are available as CE-IVD products for In Vitro Diagnostic Use in the EEA, the United Kingdom, Switzerland, and Israel. Information about products that may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications for use. Please contact us to obtain the appropriate product information for your country of residence.
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