SBIR-STTR Award

HLS17-03 Anemia, or low blood hemoglobin levels, is a public health problem affecting over 2 billion people worldwide. Over 1 billion of people affected live in low-resource settings. Currently, anemia is typically diagnosed with a complete blood count (CBC) via a clinical hematology analyzer that is clinic or hospital- based. To that end, Sanguina has completed development of a first generation AnemoCheck test, a disposable, color-based test for screening and monitoring anemia. AnemoCheck utilizes one drop of blood (5µL) from a finger stick. Blood is then mixed with our assay components and within two minutes, a 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 anemia, if any. Hence, this simple assay with a straightforward, color-based visual readout is similar to a urine analysis dipstick and does not require any electricity nor additional equipment. We have published clinical assessments successfully completed on AnemoCheck technology (Tyburski, et al, J Clin Invest. 2014 McGann et al, AJH, 2015) and fully developed this solution-based first generation product. However, we realize the limitations on our current test for use in low-resource settings. Many resource-poor regions cannot afford standard hematology analyzers or store them in current infrastructure. Additionally, although several point-of-care and portable anemia diagnostic assays exist, there is currently no inexpensive, disposable, test robust enough to handle storage in extreme temperature's (40-60°C) often experiences by remote, low-resource settings. Therefore, a 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 settings. To that end, Sanguina has recently developed modified chemistry, utilizing dry components we call AnemoCheck-D, which has the potential to be stored for extended periods in extreme environments and serve low-resource setting populations. In this Phase I SBIR, we plan (Milestone 1) to develop robust dry form chemistry, optimizing each ingredient for accuracy and stability and (Milestone 2) develop robust assay packaging specifically suited for target low resource setting storage in extreme temperatures. We propose to evaluate the robustness of the assay by performing verification testing, interference testing, and a (Milestone 3) conduct a pilot clinical assessment testing within a target sickle cell population, with a head-to-head comparison with a standard clinical hematology analyzer. Comprised of a successful serial bioentrepreneur, a clinical hematologist/bioengineer, a renowned chemist, and a bioengineer/original inventor of the POC anemia test, our interdisciplinary team that leads Sanguina, LLC will ensure the success of this project. Completion of these Phase I milestones will enable us to put a design lock on the chemistry of the assay, finalize 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 Sanguina. This work will feed into a Phase II, where we plan to conduct larger clinical assessments to satisfy regulatory and quality requirements specific to target regions. Ultimately, our AnemoCheck-D test could offer affordable anemia testing for a variety of settings and populations, worldwide. Ultimately, availability of screening can help direct treatment of anemia, the world's most common blood disorder, improve clinical outcomes and save lives.

Public Health Relevance Statement:
Public Health Relevance Anemia, the most common blood disease that affects over 2 billion people worldwide, often requires a clinic or hospital-based blood count for diagnosis, but in low resource settings, where anemia is more prevalent, blood counts are, unfortunately and ironically, too expensive to be made available. Our company is dedicated to developing new, inexpensive anemia tests to be used in low resource nations and for this grant, we will modify our existing anemia test technology such that it can be stored and used in the harsh environments (extreme heat and humidity) of those global health settings. This assay could provide populations with the highest risk for severe anemia an affordable option for screening and monitoring anemia, which will then enable allocation of rare medical resources and services for the men, women and children who need it most. !

Project Terms:
Adult; Affect; Anemia; base; Bedside Testings; Biochemical; Biological Assay; Biomedical Engineering; Blood; Blood specimen; cardiovascular collapse; Cessation of life; Chemicals; Chemistry; Child; Chronic; Clinic; Clinical; Clinical assessments; clinical infrastructure; Clinics and Hospitals; cognitive function; Color; Complete Blood Count; cost; cost effective; Data; design; Developing Countries; Development; Diagnosis; diagnostic assay; Diagnostic tests; Diarrhea; Drops; Drug usage; Electricity; Ensure; Environment; Equipment; Erythrocytes; Evaluation; experience; extreme heat; extreme temperature; Failure; feeding; Fingers; Formulation; Generations; Genetic; global health; Goals; Gold; Government Agencies; Grant; head-to-head comparison; Health; Healthcare; Hematological Disease; Hematologist; Hematology; Hemoglobin; Hemoglobin concentration result; High Prevalence; high risk; HIV; Hookworms; Humidity; Impairment; improved; India; Infection; inhibitor/antagonist; Institutes; Intake; Intuition; Iron; Label; Legal patent; Maintenance; Malaria; Malignant Neoplasms; Medical; men; meter; Methods; Modeling; Monitor; Morbidity - disease rate; novel; Nutrient; Outcome; Oxidation-Reduction; Patients; Pharmaceutical Preparations; Phase; Physical Function; point of care; Population; portability; Pregnancy Outcome; Productivity; Public Health; public health relevance; Publishing; Reaction; Reagent; reagent testing; Recording of previous events; Refrigeration; Regulatory Pathway; Research Infrastructure; Resources; Risk; screening; Services; Severities; Sickle Cell; Sickle Cell Anemia; Small Business Innovation Research Grant; success; Tablets; Technology; Temperature; Testing; Training; Universities; Urine; Visual; Woman; Work

Anemia, characterized by low blood hemoglobin (Hgb) levels, is the world's most common blooddisorder, afflicting nearly two billion people, with 80 million at high risk in the US alone. Due to numerousetiologies, anemia can also be chronic and potentially life-threatening. Given the severity and epidemiologicalimpact of anemia, screening is crucial for those at risk for anemia, and those with diagnosed chronic anemiarequire 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 trainedphlebotomists/technicians. However, access to this test is cost-prohibitive and inconvenient. Due to theinconvenience, and cost associated with CBCs, point-of-care (POC) Hgb diagnostics have been developed, butcurrent systems all suffer from high-cost (handheld Hgb meters cost USD $30-$1000), or inaccuracy, and nonon-invasive, inexpensive, easily accessible over the counter (OTC) anemia diagnostic exists that accuratelymeasures 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 productscomprising 3 key products 1) AnemoCheck for home use - a "single drop of blood" fingerstick test that utilizesour FDA-cleared technology to elicit a color change that correlates to Hgb levels, 2) AnemoCheck Mobile - asmartphone app that screens for anemia using only smartphone photos and the phone's native hardware and3) AnemoCheck MyMobile, a marriage of the Home and Mobile products in which the app is calibrated withthe AnemoCheck blood test to significantly improve the apps accuracy and personalize Hgb level results. Thesetechnologies have been published in high-impact, peer-reviewed journals (Tyburski et at., JCI 2014, Mannino etal, Nature Communications 2018). The goal of this Phase II SBIR is to finalize AnemoCheck MyMobile, Sanguina has leveraged the ubiquity of smartphones and the familiarity of fingerpick-based self-testingto develop a paradigm shifting platform for managing anemia at home and maintaining wellness, as demandedby people at the highest risk for anemia. The goals of this Phase II SBIR are to validate the AnemoCheckMyMobile platform for management of anemia in chronic anemic patients, which was developed utilizing phaseI SBIR funding. We will leverage our collaborations with co-PI and co-I's Robert Sidonio, MD, Wilbur Lam, MD,PhD, and Traci Leong, PhD of Emory University School of Medicine to conduct our clinical validation on a cohortof bleeding disorder, hemolytic anemia, sickle cell disease and hemoglobinopathy patients with chronic anemia,and healthy individuals. We plan to validate this platform for managing general wellness and screening andmonitoring anemia via the following proposed aims 1) Personalize AnemoCheck Mobile to create AnemoCheckMyMobile for chronic anemia patients and 2) Validate AnemoCheck MyMobile as a personalized system forchronic anemia management.

Public Health Relevance Statement:
PROJECT NARRATIVE Anemia, the most common blood disease that affects over 2 billion people worldwide, currently requires a clinic or hospital-based blood count for diagnosis. We have recently developed a novel, multi-faceted anemia screening and monitoring suite of products comprising 3 key products for home testing: 1) AnemoCheck for home use - a "single drop of blood" fingerstick test that utilizes our FDA-cleared technology to elicit a color change that correlates with degree of anemia, 2) AnemoCheck Mobile - a smartphone app that screens for anemia using only smartphone photos and the phone itself with no additional equipment and 3) AnemoCheck MyMobile- a marriage of the AnemoCheck blood test and AnemoCheck Mobile products in which the app is "personalized" for each patient to significantly improve accuracy and enable self-monitoring of anemia. In this proposal, we aim to 1) Finalize the "personalization" AnemoCheck Mobile algorithms to create AnemoCheck MyMobile for chronic anemia patients and 2) Validate AnemoCheck MyMobile as a personalized system for chronic anemia management to shift the paradigm-shifting anemia screening and monitoring platform will markedly improve patient quality of life in an extremely cost-effective manner and empower patients to manage their own care.

Project Terms:
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