SBIR phase II: A personalized, non-invasive hemoglobin level monitoring and management platform for chronic anemia patients.

贫血是世界上最常见的血液，以低血红蛋白(HGB)水平为特征 混乱，困扰着近20亿人，仅在美国就有8000万人处于高危状态。由于数量众多 在病因方面，贫血也可能是慢性的，并可能危及生命。考虑到严重程度和流行病学 贫血的影响，筛查对于有贫血风险的人和被诊断为慢性贫血的人至关重要 需要经常监控。目前，诊断贫血的金标准是全血细胞计数 (CBC)，这需要患者访问诊所/医院或商业实验室，并接受培训 抽血师/技师。然而，使用这种测试的成本高昂，而且不方便。由于 已经开发了与CBCS、护理点(POC)HGB诊断相关的不便和成本，但是 目前的系统都存在成本高(手持HGB测量仪的成本为30-1000美元)或不准确的问题，而且没有 非侵入性、廉价、易于获得的非处方药(OTC)贫血诊断存在 测量患者的HGB水平，特别是作为患者自我测试。为了应对这些关键挑战， Sanguina，Inc.开发了一套新颖的、多方面的贫血筛查和监测产品 包括3个关键产品1)家庭使用的AnemoCheck-一种使用 我们的FDA批准的技术可以引发与HGB水平相关的颜色变化，2)AnemoCheck Mobile-a 智能手机应用程序，只使用智能手机的照片和手机的本地硬件来筛选贫血 3)AnemoCheck MyMobile，家庭和移动产品的结合，应用程序的校准 AnemoCheck血液测试显著提高了应用程序的准确性，并使HGB水平结果个性化。这些 技术已发表在影响较大的同行评议期刊上(Tyburski等人，JCI 2014，Mannino等人 Al，自然通信2018)。此阶段SBIR的目标是最终确定AnemoCheck MyMobile， Sanguina利用了智能手机无处不在的优势和人们熟悉的指检自检 根据要求，开发一个管理家庭贫血和保持健康的范式转换平台 是贫血风险最高的人群所致。此阶段SBIR的目标是验证AnemoCheck 利用阶段开发的慢性贫血患者贫血管理MyMobile平台 我为SBIR提供资金。我们将利用我们与co-Pi和co-I的Robert Sidonio医学博士、Wilbur Lam医学博士、 博士和Emory大学医学院博士Traci Leong对我们的队列进行临床验证 出血性疾病、溶血性贫血、镰状细胞病和慢性贫血患者， 和健康的个体。我们计划验证该平台用于管理一般健康和筛查，并 通过以下拟议目标监测贫血1)个性化AnemoCheck Mobile创建AnemoCheck MyMobile用于慢性贫血患者和2)验证AnemoCheck MyMobile作为个性化系统用于 慢性贫血管理。

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.