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

Description

Parent Project AbstractHLSAnemiaor low blood hemoglobin levelsis a public health problem affecting overbillion people worldwideOverbillion of people affected live in low resource settingsCurrentlyanemia is typically diagnosed with a complete blood countCBCvia a clinical hematology analyzer that is clinic or hospital basedTo that endSanguina has completed development of a first generation AnemoCheck testa disposablecolorbased test for screening and monitoring anemiaAnemoCheck utilizes one drop of bloodLfrom a finger stickBlood is then mixed with our assay components and within two minutesa redox reaction between the assay s reagents and the hemoglobin in the patient s blood will lead to a specific color change of the assay that correlates with the patient s degree of anemiaif anyHencethis simple assay with a straightforwardcolorbased visual readout is similar to a urine analysis dipstick and does not require any electricity nor additional equipmentWe have published clinical assessments successfully completed on AnemoCheck technologyTyburskiet alJ Clin InvestMcGann et alAJHand fully developed this solution based first generation productHoweverwe realize the limitations on our current test for use in low resource settingsMany resource poor regions cannot afford standard hematology analyzers or store them in current infrastructureAdditionallyalthough several point of care and portable anemia diagnostic assays existthere is currently no inexpensivedisposabletest robust enough to handle storage in extreme temperature sCoften experiences by remotelow resource settingsThereforea robust disposable test for detecting or monitoring anemia akin to point of care testing would enable populations in low resource settings to diagnose and screen for anemia in relatively remote settingsTo that endSanguina has recently developed modified chemistryutilizing dry components we call AnemoCheck Dwhich has the potential to be stored for extended periods in extreme environments and serve low resource setting populationsIn this Phase I SBIRwe planMilestoneto develop robust dry form chemistryoptimizing each ingredient for accuracy and stability andMilestonedevelop robust assay packaging specifically suited for target low resource setting storage in extreme temperaturesWe propose to evaluate the robustness of the assay by performing verification testinginterference testingand aMilestoneconduct a pilot clinical assessment testing within a target sickle cell populationwith a head to head comparison with a standard clinical hematology analyzerComprised of a successful serial bioentrepreneura clinical hematologist bioengineera renowned chemistand a bioengineer original inventor of the POC anemia testour interdisciplinary team that leads SanguinaLLC will ensure the success of this projectCompletion of these Phase I milestones will enable us to put a design lock on the chemistry of the assayfinalize our product with packaging and labeling and create a manufacturing plan that is specifically suited and cost effective for low resource settings while remaining feasible for SanguinaThis work will feed into a Phase IIwhere we plan to conduct larger clinical assessments to satisfy regulatory and quality requirements specific to target regionsUltimatelyour AnemoCheck D test could offer affordable anemia testing for a variety of settings and populationsworldwideUltimatelyavailability of screening can help direct treatment of anemiathe world s most common blood disorderimprove clinical outcomes and save lives Parent Public Health Relevance Anemiathe most common blood disease that affects overbillion people worldwideoften requires a clinic or hospital based blood count for diagnosisbut in low resource settingswhere anemia is more prevalentblood counts areunfortunately and ironicallytoo expensive to be made availableOur company is dedicated to developing newinexpensive anemia tests to be used in low resource nations and for this grantwe will modify our existing anemia test technology such that it can be stored and used in the harsh environmentsextreme heat and humidityof those global health settingsThis assay could provide populations with the highest risk for severe anemia an affordable option for screening and monitoring anemiawhich will then enable allocation of rare medical resources and services for the menwomen and children who need it most