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) in addition to operating a health institution.
The collaboration establishes a framework in which the two companies may develop Clinical Trial Assays (CTAs) and 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 is outfitting a CAP-accredited, CLIA-certified laboratory in a Belfast health institution for routine genomic 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 companies will support Pharma companies with a streamlined offering from study design through clinical execution. Under the agreement, SOPHiA GENETICS and ARC plan to co-sell CTA and evidence generation services to Pharma, providing them with a trusted platform to support diagnosis, treatment, and decision-making.
Beyond potential 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.