Montpellier, France – November 14, 2024 – SeqOne, a pioneer in clinical genomic data interpretation, today announced its SeqOne Platform has received certification under IVD Regulation EU 2017/746 (IVDR) from the notified body GMED. This milestone establishes the SeqOne Platform as one of the first comprehensive bioinformatics solutions certified as a Class C medical device for next-generation sequencing (NGS) data analysis in oncology and rare disease diagnostics.
“This certification represents a pivotal milestone that goes far beyond regulatory compliance,” said Martin Dubuc, CEO of SeqOne. “It reflects years of dedication from our entire team in building a platform that combines cutting-edge technology with the highest standards of quality and safety. As genomics becomes increasingly central to routine clinical care, this IVDR certification validates our commitment to providing healthcare professionals with trusted, transparent, and reliable tools for genomic analysis. Our platform not only meets today’s stringent requirements but is architected to adapt to evolving technologies and standards in precision medicine. Most importantly, we remain deeply committed to an agile, customer-centric approach in evolving the SeqOne Platform, ensuring that our continuous innovation aligns with both IVDR requirements and the evolving needs of genomic labs and healthcare professionals.”
Meeting the Highest Standards in Clinical Diagnostics
The SeqOne Platform’s IVDR certification as a Class C device represents one of the highest risk classifications for in vitro diagnostic software, specifically designed for genetic testing and companion diagnostics. This classification acknowledges the critical role of bioinformatics in clinical decision-making, particularly in oncology and rare disease diagnostics where accurate variant interpretation directly impacts patient care.
The IVDR Class C designation applies to high-risk diagnostic devices, including Software intended for genetic testing, Companion diagnostics, Cancer screening, Hereditary disorder screening, etc.
This classification requires:
- Thorough clinical evidence and performance evaluation
- Stringent quality management systems
- Regular audits by notified bodies
- Enhanced post-market surveillance
- Comprehensive technical documentation
The certification builds upon SeqOne’s established ISO 13485:2016 certified Quality Management System (QMS), demonstrating our comprehensive approach to quality in medical device software development. This internationally recognized QMS standard ensures:
- Systematic control over software development and validation processes
- Rigorous risk management throughout the product lifecycle
- Comprehensive documentation and traceability
- Structured approach to continuous improvement
- Regular independent audits of quality processes
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About SeqOne
SeqOne is a leading European provider of AI-powered software for next-generation sequencing (NGS) data analysis in oncology and rare diseases. Its cloud-based platform transforms complex genomic data into fast, precise, and actionable insights, supporting molecular labs in delivering life-saving diagnoses and treatments. The SeqOne Platform is a CE-IVD Class C certified under IVDR in vitro diagnostic medical device. Driven by the vision of personalized medicine for every patient, everywhere, SeqOne is scaling the future of genomic medicine—one lab at a time.
For more information, visit seqone.com.
