Commercialization of a CT-based Technique for BOS Assessment

接受异基因造血干细胞移植(allo-HSCT)或肺移植的患者 移植通常会出现肺部并发症。这些移植受者通常会患上一种 可能危及生命的疾病称为闭塞性细支气管炎综合征(BOS)，一种 移植物抗宿主病(GVHD)的后果。早期诊断BOS是维持BOS的关键 生活质量和提高总体存活率，因为一旦BOS成为 在肺组织中建立。与其他肺部并发症一样，BOS的治疗仍然有限 与BOS相似的症状，如感染，很常见，最终会延误诊断。 临床获得PRM技术，具有同时描绘特定疾病的能力 疾病，将对这一患者群体产生直接和积极的影响。为了这个 移植受者有望进入常规临床应用的技术商业化 必须使用相关CT在临床工作流程中开发、测试和集成应用程序 数据和适合于这一患者群体的PRM技术。在这项拨款工作中，我们建议 通过密歇根大学(UM)和英比奥有限责任公司之间的密切合作实现这一目标 调查人员。因此，这项快速通道提案的具体目标将开发一种商业PRM 软件应用，包括FDA 510(K)所需的产品测试和数据采集 应用配对CT数据和HSCT及肺移植受者信息。

Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lung transplantation often develop pulmonary complications. These transplant recipients often develop a potentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), a consequence of graft versus host disease (GVHD). Early diagnosis of BOS is vital for maintaining quality of life and improving overall survival, as few treatment options exist once BOS becomes established in lung tissue. Treatments for BOS remain limited, as other pulmonary complications with similar symptoms to BOS, such as infections, are prevalent and ultimately delay diagnosis. Clinical access to the PRM technology, with its ability to simultaneously delineate specific diseases, would have an immediate and positive impact on this patient population. For this promising technology to enter routine clinical use for transplant recipients a commercial application must be developed, tested and integrated within the clinical workflow using relevant CT data and a PRM technique adapted to this patient population. In this grant effort, we propose to achieve this goal through our close partnership between University of Michigan (UM) and Imbio, LLC investigators. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRM software application, including product testing and data acquisition necessary for a FDA 510(k) application using paired CT data and HSCT and lung transplant recipient information.