Development of a Laboratory Data Processing and Management Platform for Cancer Detection Tests

The client faces difficulties in efficiently processing, storing, and managing complex laboratory assay data related to blood-based cancer detection tests. Their small development team lacks comprehensive frontend solutions to handle scanned microarray slide images, automate data calculations, and facilitate sample analysis, resulting in bottlenecks and potential compliance issues. There is a need for scalable and compliant software tools to improve laboratory technician workflows and enable rapid, accurate test results generation.

A medium to large biotech or diagnostics company specializing in developing blood-based diagnostic tests for early disease detection, with a focus on cancer biomarker analysis and laboratory assay automation.

• Develop a frontend application to facilitate processing, storage, and management of laboratory assay data, including image analysis and result generation.
• Implement automated data acquisition and analysis workflows to optimize sample processing speed and accuracy.
• Create scalable, cloud-configurable software to support reagent production and diagnostic testing operations.
• Ensure compliance with relevant medical device standards (e.g., IEC 62304) to support quality assurance and regulatory requirements.
• Enhance laboratory technician productivity by providing an intuitive interface for assay data handling and reporting.

• Image processing module for scanning and analyzing microarray slide images to extract raw data.
• Automated calculation engine to derive test results from acquired data.
• Secure data storage system for sample information, raw data, and analysis results.
• User interface tailored for laboratory technicians, enabling easy sample input, data review, and reporting.
• Support for reagent creation, production, and management workflows.
• Scalable cloud deployment options to support variable workloads and future growth.
• Compliance with industry standards for medical device software quality and security.

• Imaging systems for microarray slide scanning
• Laboratory information management systems (LIMS)
• Regulatory compliance modules or standards to ensure alignment with IEC 62304
• Data repositories for sample and reagent management

• High scalability to support increasing sample volumes and expanding workflows
• Performance optimization for rapid image processing and data analysis
• Robust security features to ensure patient data confidentiality and compliance
• Audit trails and traceability for regulatory audits
• 99.9% system uptime with disaster recovery capabilities

The implementation of this platform is expected to streamline laboratory workflows, automate data analysis, and ensure compliance with medical standards, ultimately enabling rapid and accurate cancer detection. This will improve test turnaround times, enhance data integrity, and support the scaling of diagnostic product development, leading to increased market readiness and improved patient outcomes.