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Principal Investigator: Erika Amy Tyburski
Organization: SANGUINA, LLC
Fiscal Year: 2024
Award: $986,670
Funding agency: National Heart Lung and Blood Institute
Anemia, characterized by low blood hemoglobin (Hgb) levels, is the world’s most common blood
disorder, afflicting 1.6 billion people, with 80 million at high risk in the US alone. Due to numerous etiologies,
anemia can also be chronic and potentially life-threatening. Given the severity and epidemiological impact of
anemia, screening is crucial for those at risk for anemia, and those with diagnosed chronic anemia require
frequent monitoring. Currently, the gold-standard diagnostic test for anemia is the complete blood count (CBC),
which requires a patient visit to a clinic/hospital or commercial lab as well as trained phlebotomists/technicians.
However, access to this test is cost-prohibitive and inconvenient. Due to the inconvenience, and cost associated
with CBCs, point-of-care (POC) Hgb diagnostics have been developed, but current systems all suffer from high-
cost (handheld Hgb meters cost USD $30-$1000), or inaccuracy, and no non-invasive, inexpensive, easily
accessible over the counter (OTC) anemia diagnostic exists that accurately measures a patient’s Hgb levels,
especially as a patient self-test. To address these critical challenges, Sanguina, Inc has developed a novel,
multi-faceted anemia screening and monitoring suite of products comprising 3 key products 1) AnemoCheck
Home (under FDA interactive review) – a “single drop of blood” fingerstick test that utilizes our clinical FDA-
cleared technology to elicit a color change that correlates to Hgb levels, 2) The AnemoCheck app - a
smartphone app that screens for anemia using only smartphone photos and the phone’s native hardware and
3) AnemoCheck MyMobile, a marriage of the Home and app products in which the app is calibrated with the
AnemoCheck Home to significantly improve the apps accuracy and personalize Hgb level results. These
technologies have been published in high-impact, peer-reviewed journals (Tyburski et at., JCI 2014, Mannino et
al, Nature Communications 2018). Sanguina has leveraged the ubiquity of smartphones and the familiarity of
fingerpick-based self-testing to develop a paradigm-shifting platform for managing chronic anemia at home.
The goal of this Phase IIB SBIR is to complete additional studies requested by FDA for human
factors validation and head-to-head clinical performance in actual home settings of AnemoCheck
MyMobile with AnemoCheck Home for training the algorithm. We will leverage our collaborations with co-I,
Dr. Wilbur Lam and existing relationships with the Sickle Cell Foundation of Georgia, Cooley’s Anemia
Foundation and eMed to conduct our expanded multi-site clinical validation on a diverse cohort of adult and
pediatric patients with chronic anemia. Results will be compared against AnemoCheck MyMobile when
trained by a traditional blood test and traditional blood testing in order submit to FDA for clearance of
AnemoCheck MyMobile as the first non-invasive smartphone app technology for anemia management
in those with chronic anemia.
Terms: <21+ years old><Address><Adult><Adult Human><Affect><Algorithms><Android App><Android Application><Anemia><Assay><Beds><Bioassay><Biological Assay><Blood><Blood Diseases><Blood Reticuloendothelial System><Blood Tests><Calibration><Cancers><Cardiovascular><Cardiovascular Body System><Cardiovascular Organ System><Cardiovascular system><Caring><Causality><Cell Phone><Cell Phone Application><Cell phone App><Cellular Phone><Cellular Phone App><Cellular Phone Application><Cellular Telephone><Chronic><Chronic Kidney Failure><Chronic Renal Disease><Chronic Renal Failure><Clinical><Clinical Research><Clinical Study><Clinics and Hospitals><Clinics or Hospitals><Collaborations><Color><Communication><Complete Blood Count><Computer software><Cooley's anemia><Data><Death Rate><Detection><Devices><Diagnosis><Diagnostic><Diagnostic Reagent Kits><Diagnostic tests><Drops><Epidemiology><Equipment><Equity><Erythroblastic Anemia><Etiology><Familiarity><Fatigue><Finger Nail><Fingernail><Fingers><Foundations><Funding><Goals><Hb SS disease><HbSS disease><Head><Health><Heart Vascular><Hematologic Diseases><Hematologic Tests><Hematological Disease><Hematological Disorder><Hematological Tests><Hematology><Hematology Testing><Hemoglobin><Hemoglobin S Disease><Hemoglobin concentration result><Hemoglobin sickle cell disease><Hemoglobin sickle cell disorder><Home><Human><Human Resources><Image><Journals><Lack of Energy><Left><Life><Link><Magazine><Malignant Neoplasms><Malignant Tumor><Malnutrition><Manpower><Marketing><Marriage><Measurement><Measures><Mediterranean Anemia><Methods><Mobile Phones><Modern Man><Monitor><Morbidity><Morbidity - disease rate><Nature><Nutritional Deficiency><Outcome><Output><Oxidation-Reduction><Patients><Peer Review><Performance><Persons><Phase><Phone><Population><Pregnant Women><Productivity><Public Health><Publishing><QOL><Quality Control><Quality of life><Reaction><Reagent><Recommendation><Recurrence><Recurrent><Redox><Risk><Risk Assessment><SBIR><Severities><Sickle Cell><Sickle Cell Anemia><Small Business Innovation Research><Small Business Innovation Research Grant><Smart Phone App><Smart Phone Application><Smartphone App><Software><Source><Structure of nail of finger><Symptoms><System><Technology><Telephone><Testing><Thalassemia><Thalassemia Major><Time><Training><Translations><Undernutrition><Validation><Visit><adulthood><algorithm training><blood disorder><causation><cell phone based app><child patients><chronic kidney disease><circulatory system><clinical research site><clinical site><cohort><cost><design><designing><diagnostic kit><diagnostic tool><dietary deficiency><disease causation><empowerment><epidemiologic><epidemiological><expectant mother><expecting mother><gastrointestinal><hemoglobin level><high risk><home test><home-based test><homes><iOS app><iOS application><iPhone><iPhone App><iPhone Application><imaging><improved><improved outcome><individual patient><malignancy><malnourished><meter><mobile phone app><mortality rate><mortality ratio><neoplasm/cancer><novel><nutrition deficiency><nutrition deficiency disorder><nutritional deficiency disorder><oxidation reduction reaction><pediatric patients><personalization of treatment><personalized medicine><personalized therapy><personalized treatment><personnel><point of care><pregnant mothers><response to therapy><response to treatment><screening><screenings><self testing><sickle RBC><sickle cell disease><sickle cell disorder><sickle disease><sickle erythrocyte><sickle red blood cell><sicklemia><smart phone><smartphone><smartphone application><smartphone based app><smartphone based application><technology implementation><technology validation><test kit><therapeutic response><therapy response><tool><translation><treatment response><treatment responsiveness><validation studies><validations><β-thalassemia major>