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

Description

AbstractAnemiacharacterized by low blood hemoglobinHgblevelsis the world s most common blood disorderafflicting nearly two billion peopleespecially young childrenthe elderlyand women of childbearing ageDue to numerous etiologiesanemia can also be chronic and potentially life threateningCurrentlythe gold standard diagnostic test for anemia is the complete blood countCBCwhich requires a patient visit to a clinic hospital or commercial lab as well as trained phlebotomists techniciansHoweveraccess to this test is cost prohibitive in low resource settingsLRSwhere unfortunatelyanemia is most prevalent worldwide with the highest rates of anemia associated mortalityDue to the inconvenienceinvasivenesslack of accessibilityand cost associated with CBCspoint of carePOCHgb diagnostics have been developedbut current systems all suffer from high costhandheld Hgb meters cost USD $$inaccuracythe need for blood samplingor reagent instability in the potentially harsh environments of LRSCurrentlyno non invasiveinexpensiveeasily accessiblei eexternal device free and widely availablePOC anemia diagnostic exists that accurately measures a patient s Hgb levelsespecially as a patient self testTo address these critical challengesSanguinaLLC has developed a novelnon invasive smartphone app that measures blood Hgb levels using only smartphone photos and the smartphone s native hardware and has recently published the initial presentation and clinical assessment of this novel technologyMannino et alNature CommunicationsInterestinglywhereas medical infrastructure in LRS is lackingmobile phone infrastructure is comparatively advanced and significant parts of the population in LRS have smartphone accessenabling smartphone based solutions to be ideal diagnostics in global healthAs conducting a true clinical validation study in global health settings requires access to gold standard CBC Hgb levelswhich is logistically difficult to implement in LRSwe will conduct our study on local refugee populations recently emigrated from LRS as a surrogate global health populationAnemia affectsof these refugees and as suchnecessitates intake screening and monitoring through anemia control programsThis population represents an ideal study population to locally evaluate the potential of our app to effectively screen anemia in LRSIn this Phase I SBIRwe aim toevaluate the accuracy of our low costnon invasive smartphone Hgb level measurement app against Hgb levels obtained with routinely used POC tools in the refugee population at the Dekalb County Board of HealthAssess the usability of the app in the hands of clinicians and patientsandDevelop a consumer facinguser friendly app based on clinician and patient feedbackOverallthe successful completion of this proposal will result in a truly paradigm shifting and cost effective tool in the management of anemia worldwide and especially in global health settings Public Health Relevance Anemiathe most common blood disease that affects overbillion people worldwidecurrently requires a clinic or hospital based blood count for diagnosisWe have recently developed a non invasive smartphone app for anemia detection that requires no additional equipment or training and here we propose tovalidate our technology via direct head to head comparison with the gold standard blood counts and two existing point of care anemia testsassess usability of appandrefine our app to for optimized ease of useOur smartphone anemia app has the potential to provide on demand access for low resource settings where medical equipment and personnel are severely limitedbut smartphones and internet are widely availablethus dramatically increasing access to detection of anemia to populations who need it most!