Biomarkers identify patient response to therapy. The potential immune-checkpoint biomarker, Inducible T-cell COStimulator (ICOS), expressed on regulating T-cell activation and involved in adaptive immune responses, is of great interest. We have previously shown that open-source software for digital pathology image analysis can be used to detect and quantify ICOS using cell detection algorithms based on traditional image processing techniques. Currently, artificial intelligence (AI) based on deep learning methods is significantly impacting the domain of digital pathology, including the quantification of biomarkers. In this study, we propose a general AI-based workflow for applying deep learning to the problem of cell segmentation/detection in IHC slides as a basis for quantifying nuclear staining biomarkers, such as ICOS. It consists of two main parts: a simplified but robust annotation process, and cell segmentation/detection models. This results in an optimised annotation process with a new user-friendly tool that can interact with1 other open-source software and assists pathologists and scientists in creating and exporting data for deep learning. We present a set of architectures for cell-based segmentation/detection to quantify and analyse the trade-offs between them, proving to be more accurate and less time consuming than traditional methods. This approach can identify the best tool to deliver the prognostic significance of ICOS protein expression.

Artificial intelligence (AI) is transforming many fields, including healthcare and medicine. In biomarker discovery, AI algorithms have had a profound impact, thanks to their ability to derive insights from complex high-dimensional datasets and integrate multi-modal datatypes (such as omics, electronic health records, imaging or sensor and wearable data). However, despite the proliferation of AI-powered biomarkers, significant hurdles still remain in translating them to the clinic and driving adoption, including lack of population diversity, difficulties accessing harmonised data, costly and time-consuming clinical studies, evolving AI regulatory frameworks and absence of scalable diagnostic infrastructure. Here, we provide an overview of the AI toolkit available for biomarker discovery, and we discuss exciting examples of AI-powered biomarkers across therapeutic areas. Finally, we address the challenges ahead of us to ensure that these technologies reach patients and users globally and unlock a new era of fast innovation for precision medicine.

Integrating artificial intelligence (AI) tools in the tissue diagnostic workflow will benefit the pathologist and, ultimately, the patient. The generation of such AI tools has two parallel and yet interconnected processes, namely the definition of the pathologist’s task to be delivered in silico, and the software development requirements. In this review paper, we demystify this process, from a viewpoint that joins experienced pathologists and data scientists, by proposing a general pathway and describing the core steps to build an AI digital pathology tool. In doing so, we highlight the importance of the collaboration between AI scientists and pathologists, from the initial formulation of the hypothesis to the final, ready-to-use product.

In this article, we propose ICOSeg, a lightweight deep learning model that accurately segments the immune-checkpoint biomarker, Inducible T-cell COStimulator (ICOS) protein in colon cancer from immunohistochemistry (IHC) slide patches. The proposed model relies on the MobileViT network that includes two main components: convolutional neural network (CNN) layers for extracting spatial features; and a transformer block for capturing a global feature representation from IHC patch images. The ICOSeg uses an encoder and decoder sub-network. The encoder extracts the positive cell’s salient features (i.e., shape, texture, intensity, and margin), and the decoder reconstructs important features into segmentation maps. To improve the model generalization capabilities, we adopted a channel attention mechanism that added to the bottleneck of the encoder layer. This approach highlighted the most relevant cell structures by discriminating between the targeted cell and background tissues. We performed extensive experiments on our in-house dataset. The experimental results confirm that the proposed model achieves more significant results against state-of-the-art methods, together with an 8× reduction in parameters.