time per case. The product suite has three modules on a single deployment. Qnomx Report automates clinical NGS reporting. Qnomx Insight supports the clinical interpretation of human sequence variants by retrieving, organising, and synthesising evidence from curated biomedical sources, producing structured, source-cited draft content for review and finalisation by a qualified molecular pathologist. Qnomx DataStudio serves as the lab knowledge base and system of record. Every output comes with a traceable, source-based evidence chain. When the evidence is unclear or contradictory, the system defers rather than forcing a call. The qualified user remains responsible for the final classification. Qnomx is one of the first variant interpretation platforms designed for simultaneous IVDR Class C and EU AI Act conformity, with the quality management system built for both regulatory frameworks from inception rather than retrofitted after certification. ISO 27001 certification obtained in May 2026; MDR submission is planned for Q4 2026; clinical validation runs with Vall d'Hebron Institute of Research in Barcelona. The team is led by Dr. Jörg Hölzing (former Roche SVP, MD of mySugr), James Creeden MD PhD (former CMO Roche Diagnostics, interpreted 5,000+ cancer cases at Foundation Medicine), and Marcus Olivecrona (pioneered GenAI for drug discovery at AstraZeneca, shipped MDR Class IIa AI software at Visiba Care). Headquartered in Basel, Switzerland.