ISOPLEXIS CORPORATION — Department of Health and Human Services SBIR Phase II: NIBIB

Description

MyelofibrosisMFbelongs to a group of closely related chronic blood diseasesmyeloproliferative disordersMPDMost MF patients have no symptoms or present with nonspecific constitutional symptomsweight lossfatigueas such an early stage diagnosis of MF is challengingMF is clinically suspected when patients present with an enlarged spleen and or with anemiathrombocytopeniaor leukopenia leukocytosishoweverthese are neither sensitive nor specific enough to establish a diagnosis of MFHistological examination is unable to detect early onset bone marrow fibrosis or predict the progression from pre fibrotic polycythemia veraPVessential thrombocythemiaETto MF or the likelihood of malignant transformation of MF to leukemiaIsoPlexis is developing a device to monitor individual multi secreting hematopoietic cells that will not only be able to analyze bone marrow samples but also capture and analyze rare cell count from easily obtainable peripheral blood samples allowing for early diagnosis and better treatment optionsIsoPlexis has already validated the device to CDand CDcells and seeks to demonstrate its critical value to detecting rare circulating hematopoietic cellsThe IsoPlexis device can isolate thousands of individual live cells and analyzesecreted proteins to characterize the complexcell specific inflammatory response that is correlative to the MF patient survivalThe device measures all safety and efficacy functional cytokines per cell and can predict therapeutic responses and potentially enable patient stratification and improved treatment managementHereinwe propose to use the SBIR direct to Phase II grant to demonstrate the validity of our system for use in characterizingmonitoring and predicting the progression of MPD or its treatmentWe propose the following specific aimsAIMDevelop a fully packaged singlecell protein secretion assay device to meet commercial usability and validity standardsbenchmarking sensitivityspecificityand sample variability for hematopoietic cells from MF patient bone marrow samples collected at MSKCCAIMDevelop algorithmic software and protocols to adeptly compare single cell cytokine profiles between patients with polycythemia veraPVessential thrombocytosisETand MFAIMImplement enrichment technologyon chipthat IsoPlexis is currently developing as an all in one device to enrich rare cells from circulating blood and detect single cell activity from that subpopulation