A Preliminary Evaluation of “GenDAI”, an AI-Assisted Laboratory Diagnostics Solution for Genomic Applications

Genomic data enable the development of new biomarkers in diagnostic laboratories. Examples include data from gene expression analyses or metagenomics. Artificial intelligence can help to analyze these data. However, diagnostic laboratories face various technical and regulatory challenges to harness these data. Existing software for genomic data is usually designed for research and does not meet the requirements for use as a diagnostic tool. To address these challenges, we recently proposed a conceptual architecture called “GenDAI”. An initial evaluation of “GenDAI” was conducted in collaboration with a small laboratory in the form of a preliminary study. The results of this pre-study highlight the requirement for and feasibility of the approach. The pre-study also yields detailed technical and regulatory requirements, use cases from laboratory practice, and a prototype called “PlateFlow” for exploring user interface concepts.