Advanced LIMS designed for the Altum Sequencing laboratory, optimizing the comprehensive monitoring of cancer through detailed analysis of minimal residual disease (MRD), providing crucial insights for tracking and treatment.
Integrating the LIMS required deep customization to align with the unique and complex workflows of minimal residual disease (MRD) analysis, ensuring the correct management of each stage of the process.
Establishing a complete and detailed traceability system for each sample and generated data was fundamental to comply with regulations and facilitate comprehensive audits, guaranteeing the integrity and provenance of critical information.
Ensuring strict compliance with the specific regulations and standards governing clinical laboratories handling oncology samples was a key challenge, demanding the implementation of robust controls and processes within the LIMS.
The secure and accurate transfer of a significant volume of historical information from multiple Excel spreadsheets to the new LIMS demanded meticulous planning and exhaustive validation to avoid the loss or corruption of crucial data for operational continuity.
A comprehensive strategy focused on lab collaboration to understand workflows was implemented. Detailed planning and validation of data migration from Excel were prioritized, alongside progressive training for LIMS adoption. Iterative configuration and thorough testing ensured regulatory compliance and traceability, achieving a successful transition and improved efficiency.
The LIMS implementation resulted in a significant improvement in operational efficiency and a drastic reduction in manual errors. Complete traceability of samples and data was achieved, facilitating regulatory compliance and audits. Information management was centralized and optimized, providing rapid and secure access to crucial data, which improved decision-making and the quality of laboratory results.
Phase 1
Through the development of new algorithms based on artificial intelligence and mass sequencing, and by digitalizing Precision Medicine, the project seeks to detect Minimal Residual Disease in oncology patients. The participating companies are: Altum; Bimaxpro; Cenit; and the University of Seville (US). This initiative is funded by the Ministry of Industry and Tourism within the AEI support program to enhance the competitiveness of Spanish industry, with reference AEI-010500-2024-12.Phase 2
Phase 2 of the IA4MRD project addresses two critical processes of clinical analysis through next-generation sequencing (NGS) in oncology patients: the visual validation of genetic variants and the selection of tumor markers for monitoring Minimal Residual Disease (MRD). Both steps are currently manual, slow, and dependent on the analyst's expertise, which limits their scalability, traceability, and reproducibility. This phase proposes the development of artificial intelligence (AI) models to automate and optimize these processes, integrating them into the digital platform that will be evolved in this Phase 2. Participating companies: Itexon Systems, Altum Sequencing, Cenit SL, Bimaxpro, Tecnara, University of Seville, and onTech Innovation. This initiative is funded by the Ministry of Industry and Tourism within the AEI support program to enhance the competitiveness of Spanish industry, with reference AEI-010500-2025-26.
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