Commercialization of a CT-based Technique for BOS Assessment

Patients who have undergone allogenic hematopoietic stem cell transplantationallo HSCTor lungtransplantation often develop pulmonary complicationsThese transplant recipients often develop apotentially life threatening condition known as bronchiolitis obliterans syndromeBOSaconsequence of graft versus host diseaseGVHDEarly diagnosis of BOS is vital for maintainingquality of life and improving overall survivalas few treatment options exist once BOS becomesestablished in lung tissueTreatments for BOS remain limitedas other pulmonary complicationswith similar symptoms to BOSsuch as infectionsare prevalent and ultimately delay diagnosisClinical access to the PRM technologywith its ability to simultaneously delineate specificdiseaseswould have an immediate and positive impact on this patient populationFor thispromising technology to enter routine clinical use for transplant recipients a commercialapplication must be developedtested and integrated within the clinical workflow using relevant CTdata and a PRM technique adapted to this patient populationIn this grant effortwe propose toachieve this goal through our close partnership between University of MichiganUMand ImbioLLCinvestigatorsThus the Specific Aims of this Fast Track proposal will develop a commercial PRMsoftware applicationincluding product testing and data acquisition necessary for a FDAkapplication using paired CT data and HSCT and lung transplant recipient information Patients who have undergone allogenic hematopoietic stem cell transplantationallo HSCTor lungtransplantation often develop pulmonary complicationsThese transplant recipients often develop apotentially life threatening condition known as bronchiolitis obliterans syndromeBOSaconsequence of graft versus host diseaseGVHDIn this applicationwe propose to extend our FDAapproved Lung Density Analysis softwarewhich is currently used for COPD diagnosisto aid in theearly diagnosis ofBOSThis software is based on a technique calledParametric Response MappingPRMwhich has been featured in Nature Medicine as a novel CT based technique for assessment ofsmall airways diseaseThe Specific Aims of this Fast Track proposal will develop a commercial PRMsoftware applicationincluding product testing and data acquisition necessary for a FDAkapproved clinical application for the BOS population