Commercialization of a CT-based Technique for BOS Assessment

Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lungtransplantation often develop pulmonary complications. These transplant recipients often develop apotentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), aconsequence of graft versus host disease (GVHD). Early diagnosis of BOS is vital for maintainingquality of life and improving overall survival, as few treatment options exist once BOS becomesestablished in lung tissue. Treatments for BOS remain limited, as other pulmonary complicationswith 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 specificdiseases, would have an immediate and positive impact on this patient population. For thispromising technology to enter routine clinical use for transplant recipients a commercialapplication must be developed, tested and integrated within the clinical workflow using relevant CTdata and a PRM technique adapted to this patient population. In this grant effort, we propose toachieve this goal through our close partnership between University of Michigan (UM) and Imbio, LLCinvestigators. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRMsoftware 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.Patients who have undergone allogenic hematopoietic stem cell transplantation (allo-HSCT) or lungtransplantation often develop pulmonary complications. These transplant recipients often develop apotentially life threatening condition known as bronchiolitis obliterans syndrome (BOS), aconsequence of graft versus host disease (GVHD). In this application, we propose to extend our FDAapproved Lung Density Analysis software, which is currently used for COPD diagnosis, to aid in theearly diagnosis of (BOS). This software is based on a technique called “Parametric Response Mapping(PRM),” which has been featured in Nature Medicine as a novel CT-based technique for assessment ofsmall airways disease. The Specific Aims of this Fast-Track proposal will develop a commercial PRMsoftware application, including product testing and data acquisition necessary for a FDA 510(k)approved clinical application for the BOS population.