FLOBIO LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTIONFLoBio LLCin conjunction with researchers at the University of Pennsylvaniahas pioneered low volume microfluidic assays to monitor blood function under diverse disease and pharmacological conditionsUtilizing over a decade of experience with protein micropatterningmicrofluidicsnovel fluorescent biosensorsand patient blood testingthe team has developed a point of carePOCdisposable chip that allows scalable manufacturing and reliable bedside emergency roomERuseSuch single use chips will be developed for rapid patient monitoring in the context of detection of direct oral anticoagulantsDOACsIn overmillion treatment visitsdirect oral anticoagulantDOACsuch as apixabanrivaroxabanor dabigatran are prescribedDOACs are used for stroke prevention in patients with atrial fibrillationA fiband in the treatment of venous thromboembolismVTEor prevention of VTE following hip or knee arthroplastyThese drugs potently inhibit coagulation Factor XaFXaor thrombinFIIaUnfortunatelythese patients are at greater risk of bleeding following trauma or emergency elective surgeryFor exampleA fib patients on DOACs that suffer a stroke are poor candidates for emergency lytic therapyA technology for monitoring DOAC levels and clearance would address an unmet medical need to identify bleeding risk during trauma or surgeryespecially in elder patients with poor renal clearance of a DOACFLoBio will implement Phase I research on the following Specific AimsManufacture of a single use chip for detection of FXa inhibitorsFXior direct thrombin inhibitorsDTIespecially at levels below andltng mLandltnMwhere clinicians specifically need diagnostic informationDevelopment of an alpha unit for chip reading with robust chip operating protocols and data analysis for scoring DOAC levelsand placement of a unit for preliminary on site tests using blood from consentingnon emergency A fib or VTE patients taking DOACs for comparison of chip readout with LCMS gold standard measurements made on stored plasmasIn Phase IIbeta units for chip reading will be developed and larger chip manufacturing runs will be implemented for deployment at a major trauma surgery site in the US and at major thrombosis treatment clinical centerIn the USthis technology has the potential to benefit nearlypatients annually on DOACs that suffer stroketraumaor a major bleed NARRATIVE FLoBio LLC proposes to designmanufactureand validate a novel microfluidic chip to monitor whole blood function including plateletthrombinand fibrin production under microfluidic conditionsThe development of a technology that is small and easy to use will be essential for bedside monitoring of patients taking direct oral anticoagulantsDOACswho suffer stroketraumaor major bleeding episodesThe need for rapid DOAC monitoring is an urgent unmet need widely recognized by cliniciansIn the USthis DOAC detection technology has the potential to benefit nearlypatients on DOACs that suffer stroketraumaor a major bleed