GenDAI – AI-Assisted Laboratory Diagnostics for Genomic Applications

An Event-Driven Architecture for Genomics-Based Diagnostic Data Processing

“…In Krause et al [11,12], we have introduced the GenDAI model for the processing and analysis of GBDD, which abstracts the different process steps and discusses necessary components and concepts to meet the requirements of GBDD processes. Figure 1 shows an overview of the GenDAI conceptual model.…”

“…A detailed discussion of various tools for qPCR analysis and their potential use for laboratory diagnostics is found in Krause et al [7,10]. The tools examined are of limited suitability for medical laboratories as they were primarily designed for research, cover only part of the laboratory process, and have not been validated for diagnostic use according to regulatory legislation [9].…”

“…The reporting and visualization of test results are also implemented as a separate microservice and thus enable both the integration of existing software through wrappers and the implementation of new approaches. These services support the interaction and perception aspect of the GenDAI conceptual model [11].…”

“…At the same time, it must be possible to trace in detail at any time how a particular diagnosis was determined to verify the accuracy and validity of the results as required by regulatory frameworks such as the In Vitro Diagnostic Regulation (IVDR) of the European Union or comparable international regulations [8,9]. Common tools for processing GBDD, on the other hand, are primarily designed for research purposes where individual experiments with variable parameters can be performed and where automation, standardization, and reproducibility are less essential [7,10]. For example, these tools may allow for individual experiments with variable parameters, making it difficult to achieve the necessary level of standardization required for clinical diagnostics.…”