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. 2022 Sep 3;35(12):1882–1887. doi: 10.1038/s41379-022-01141-4

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© The Author(s) 2022

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 2 — Schematic overview of the integration of the AI-solution into the routine pathological biomarker diagnostic practice. After the biopsy is cut and stained with H&E, it is digitally scanned and transferred for pathological examination. Samples are further processed by the traditional route including IHC screening as well as FISH and NGS, to assess ALK and ROS1 status. A final biomarker report is produced after an average of four weeks. The AI software (Imagene-AI. LTD) automatically analyses the WSI directly after the scanning of the H&E slide, taking an average of 2 min for ALK/ROS1 status inference. Flagging of samples carrying ALK or ROS1 alterations can be viewed immediately after this process by the pathologist and assist in their further analysis prioritization. After the results of the routine test panel are ready, they can be compared to the AI classifier inference. Discrepant cases can then be subjected to additional testing and clarification. AI artificial intelligence, WSI whole image slide, IHC Immunohistochemistry, FISH Fluorescence in situ hybridization, NGS Next-generation sequencing.