R44HL139250

Anemia, characterized by low blood hemoglobin (Hgb) levels, is the world’s most common blood disorder, afflicting nearly two 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 for home use – a “single drop of blood” fingerstick test that utilizes our FDA-cleared technology to elicit a color change that correlates to Hgb levels, 2) AnemoCheck Mobile - 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 Mobile products in which the app is calibrated with the AnemoCheck blood test 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). 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-testing to develop a paradigm shifting platform for managing anemia at home and maintaining wellness, as demanded by people at the highest risk for anemia. The goals of this Phase II SBIR are to validate the AnemoCheck MyMobile platform for management of anemia in chronic anemic patients, which was developed utilizing phase I 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 cohort of 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 and monitoring anemia via the following proposed aims 1) Personalize AnemoCheck Mobile to create AnemoCheck MyMobile for chronic anemia patients and 2) Validate AnemoCheck MyMobile as a personalized system for chronic anemia management.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.