Non-invasive technologies for diagnosis and monitoring of inflammatory bowel diseases

炎症性肠病（IBD）是引起胃肠道炎症的慢性免疫介导疾病。IBD已成为一项公共卫生挑战，仅在欧盟就有370万人患有该疾病，全球患病率超过0.3%。目前IBD的诊断很大程度上依赖于侵入性结肠镜检查和组织活检的组织学分析。监测IBD的微创方法在对患者进行分层和报告疾病严重程度方面存在局限性。对非侵入性技术的强烈需求，可以改善IBD患者的诊断和分层，以获得最佳治疗选择，同时监测疾病进展和对治疗的反应。这种未满足的患者需求推动了IBDSENSE项目的发展。IBDSENSE是一种创新的基于荧光的技术，可以快速和选择性地测量患者生物样品中人类酶颗粒酶B （GzmB）的活性。GzmB由T细胞分泌，而T细胞是IBD的关键效应细胞，我们已经证明其活性与IBD患者肠道炎症直接相关。该项目建立在ERC PoC项目IBDIMAGE的基础上，该团队已经验证了该技术用于测量非IBD和IBD患者生物样本中的活性GzmB，显示出比现有技术更高的灵敏度和竞争优势。来自EIC的资金将扩大IBDSENSE技术的规模，并将研究成果转化为创造市场的创新。我们已经建立了一支高素质的团队，以1)开发临床和家庭测试的原型，并在应用相关的环境中验证它们，并获得医疗保健专业人员和患者作为最终用户的意见；2)生成可信的商业计划，最终形成一家衍生公司。IBDSENSE将通过改善IBD诊断、促进疾病监测和加速个性化治疗，创造广泛的社会、经济和患者效益。

Inflammatory Bowel Diseases (IBD) are chronic immune-mediated disorders causing inflammation of the gastrointestinal tract. IBD has emerged as a public health challenge, with >3.7 million people suffering from the disease alone in the EU, and a global prevalence exceeding 0.3%. Current diagnosis of IBD relies heavily on invasive colonoscopies and histological analysis of tissue biopsies. Less invasive methods for monitoring IBD show limitations to stratify patients and report disease severity. There is a strong demand for non-invasive technologies that can improve the diagnosis and stratification of IBD patients to optimal treatment choices whilst monitoring disease progression and response to therapy. This unmet patient need drives the development of the project IBDSENSE. IBDSENSE is an innovative fluorescence-based technology that can rapidly and selectively measure the activity of the human enzyme Granzyme B (GzmB) in patient biosamples. GzmB is secreted by T cells, which are key effector cells in IBD, and we have demonstrated that its activity is directly implicated in the inflammation of the guts from IBD patients. This project builds on the ERC PoC project IBDIMAGE, where the team has validated the technology to measure active GzmB in biosamples from non-IBD and IBD patients, displaying enhanced sensitivity and competitive advantages over existing technologies. Funding from EIC will scale up the IBDSENSE technology and transform research results into a market-creating innovation. We have built a high-quality team to 1) develop prototypes for clinical and at-home testing and validate them in application-relevant environments with input from healthcare professionals and patients as end-users, and 2) generate a credible business plan that culminates in the formation of a spin-out company. IBDSENSE will create broad social, economic and patient benefit by improving IBD diagnosis, facilitating disease monitoring and accelerating personalised treatments.