BIOFLUIDICA, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

AbstractAcute myeloid leukemiaAMLis the most common adult leukemia withnew cases expected inin the US and ayear survival rate of onlyThe primary cause of death for AML is due to disease relapseThe consequences of relapse are significant with it not atypical to see a relapse rate ofof which onlysurvive afteryearsIf clinicians could easily identify a patient s minimum residual diseaseMRDbefore the tumor rapidly expands to florid to relapsepreemptive therapies could be taken with better patient outcomesUnlike other leukemiasAML s inter patient heterogeneity is immensethere is no characteristic genetic mutation or aberrant protein expression pattern for all AML patientsthus complicating the broad applicability of conventional MRD approachesPCRnext generation sequencing or multiparameter flow cytometryIf MRD could be detected in all AML patientsfrom peripheral bloodnot bone marrowwith higher sensitivity than achieved by current methodsthe corresponding assay could assist in guiding therapy to enable precision medicine resulting in better patient outcomeIn this fast tracked Phase II applicationwe propose to build upon a highly successful project to commercialize a microfluidic assay which is highly sensitive for MRD testingpermits frequent sampling by using peripheral blood as opposed to a bone marrow biopsy and is currently applicable toof all AML patientsThe assay uses a microfluidic device to detect MRD and searches unprocessed peripheral blood for circulating leukemic cellsCLCsAntibodies immobilized within three separate microfluidic devices affinity selected CLC subpopulations expressing CDCDand CDcell surface antigens commonly expressed by AML leukemic cells so that each subpopulation s CLC numbers could be tracked to determine the onset of relapseStaining against aberrant markerse gCDCDidentified low levelsmLof CLCsUsing our device to follow CLCs from AML patients after a stem cell transplantationSCTwe detected MRD at an earlier stagemonths earliercompared to both MFC and PCRwhich used bone marrow biopsiesThis earlier detection of relapse in AML post SCT can enable curative clinical decisions for AML patientsDue to the minimally invasive nature of the assayit allowed for more frequent testing as wellIn this SBIR Phase II proposalwe plan to expand and develop for commercialization our microfluidic assay for AML CLC analysis providing coverage for rtof all AML casesGiven the strong data generated to date and the urgent diagnostic need for an improved commercially available easy to implement MRD assay for frequent monitoringbroad patient coverage and early detection of AML relapse we propose a Direct to Phase II work plan toward the commercialization development of this powerful assay