An in vitro diagnostic assay for the early and accurate detection of platelet-activating antibodies associated with Heparin-induced Thrombocytopenia

PROJECT SUMMARY ABSTRACT This SBIR proposal is aimed at demonstrating feasibility of developing a technically simple and highly accurate in vitro diagnosticIVDassay for Heparin induced thrombocytopeniaHITa serious complication of heparin treatmentThe proposed assay is based on recent findings that Platelet FactorPFtreated platelets can be used for the sensitive and specific detection of clinically significant HIT antibodiesHIT is frequently suspected in heparin treated hospitalized patients who may have a number of potential causes of thrombocytopeniaTo assist with diagnosis and managementphysicians rely on two families of HIT assaysThe firstthe PFPolyanion ELISAPFELISAbased in vitro diagnosticIVDassays are sensitive for the detection of pathogenicplatelet activating HIT antibodiesbut are highly non specific such that the positive predictive valuePPVof these assays is poorThe secondmore accurate platelet activation based assays such as the Serotonin release assaySRAare technically complex and are performed using radioactivity or HPLC coupled mass spectrometry at only a small number of reference laboratoriesAs a resultPFELISAs are used to manage most HIT suspected patientsMany patients with false positive ELISAs are inappropriately treated with non heparin alternative anticoagulants which have a worse bleeding profile than heparinand unlike heparinlack an antidoteThe goal of Retham Technologies LLC is to revolutionize HIT diagnosis by replacing both the inaccurate ELISA and technically complex SRA with HITDxa simple yet accurate IVD that can be performed near patient in the hospital laboratoryHITDx is based on recent groundbreaking research that suggests that pathogenic HIT antibodies can bind to and activate PFtreated platelets in a heparinindependent mannerRecent studies demonstrate that this technology can be leveraged to provide both early and accurate HIT diagnosis and the USPTO has issued patents related to this technologyThis proposal will demonstrate feasibility of developing a self contained HIT IVD kit using PFtreated long term stored plateletsThe project will be led by DrGian VisentinMDan IVD expertwhoseveral years backwas key to developing and launching one of the most widely used PFELISAs in the US marketIn the proposed studieshe will be supported by DrPadmanabhanlead inventor of the technologyexpert consultants and Retham s advisory board membersFirm commitments from regulatoryquality assurance and business experts for the next phase of development are expected to ensure timely commercialization of this patient impacting product PROJECT NARRATIVE Heparin induced thrombocytopeniaHITis a life and limb threatening complication of heparin treatmentbut current HIT diagnostic tests are either non specific or too technically complexThe goal of this project is to demonstrate feasibility of developing a technically simple in vitro diagnosticIVDassay for the early and accurate diagnosis of HITthereby enabling timely treatment and improving patient outcomes