Translation of a personalized, non-invasive smartphone app for hemoglobin monitoring for chronic anemia patients

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.