Catalan biotech company Sequentia Biotech, a member of Catalonia.health, has announced the achievement of CE-IVD marking under the new European IVDR regulation for its MICK Clinical™ solution, designed for gastrointestinal pathogen diagnostics.
This bioinformatics platform enables microbiology laboratories to automate diagnostic processes using next-generation sequencing (NGS) data, integrating into existing workflows and supporting clinical decision-making.
MICK Clinical™ converts complex genomic data into reproducible and clinically actionable results, contributing to faster identification of gastrointestinal infections and improved patient management at early stages.
The solution has been clinically validated in a study conducted at Vall d’Hebron University Hospital in collaboration with the Vall d’Hebron Research Institute (VHIR), demonstrating a sensitivity of 91.7% and a specificity of 99.5%.
Obtaining CE-IVD marking under the IVDR (EU 2017/746) represents a significant step toward integrating genomics into clinical practice, ensuring compliance with the highest European standards for safety and clinical evidence.
With this milestone, Sequentia Biotech strengthens its position in bioinformatics applied to healthcare and in the development of omics-based solutions for clinical diagnostics.
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