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

SBIR II 期：针对慢性贫血患者的个性化、无创血红蛋白水平监测和管理平台。

• 批准号: 10325763
• 负责人: Wilbur A Lam
• 金额: $ 71.95万
• 依托单位: SANGUINA, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325763
• 关键词: Address; Affect; Algorithms; Anemia; Beds; Biological Assay; Blood; Blood Coagulation Disorders; Blood Tests; Calibration; Cardiovascular system; Caring; Cellular Phone; Child; Chronic; Clinic; Clinic Visits; Clinical; Clinical Research; Clinical assessments; Clinics and Hospitals; Collaborations; Color; Communication; Complete Blood Count; Computer software; Consumption; Custom; Data; Devices; Diagnosis; Diagnostic; Diagnostic tests; Doctor of Philosophy; Drops; Elderly woman; Epidemiology; Equipment; Etiology; Familiarity; Fatigue; Fingers; Funding; Goals; Gold; Head; Health; Hematological Disease; Hemoglobin; Hemoglobin concentration result; Hemoglobinopathies; Hemolytic Anemia; Home; Human Resources; Image; Individual; Journals; Label; Left; Life; Malignant Neoplasms; Malnutrition; Marriage; Measurement; Measures; Medical Device; Methods; Monitor; Nature; Outcome; Output; Oxidation-Reduction; Patients; Peer Review; Performance; Phase; Pregnant Women; Productivity; Protocols documentation; Public Health; Publishing; Quality of life; Reaction; Reagent; Risk; Self Management; Severities; Sickle Cell Anemia; Small Business Innovation Research Grant; Source; Structure of nail of finger; Symptoms; System; Technology; Telephone; Testing; Time; Training; Universities; Validation; Visit; base; cohort; cost; cost effective; gastrointestinal; hazard; high risk; home test; improved; individual patient; medical schools; meter; mobile application; novel; point of care; screening; self testing; smartphone Application; tool; treatment response; usability

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.

贫血的特点是血液血红蛋白（Hgb）水平低，是世界上最常见的血液 这种疾病困扰着近20亿人，仅在美国就有8000万人处于高风险之中。由于多种 除了病因外，贫血也可能是慢性的，并可能危及生命。鉴于其严重性和流行病学 贫血的影响，筛查对于那些有贫血风险的人和那些被诊断为慢性贫血的人至关重要 需要经常监测。目前，诊断贫血的金标准是全血细胞计数 (CBC)，这需要患者前往诊所/医院或商业实验室， 抽血师/技师。然而，获得这种测试是成本高昂和不方便的。由于 由于与CBC相关的不便和成本，已经开发了护理点（POC）Hgb诊断，但是 当前的系统都遭受高成本（手持Hgb计花费USD $30-$1000），或不准确，并且没有 非侵入性，廉价，易于获得的非处方（OTC）贫血诊断存在， 测量病人的血红蛋白水平，特别是作为病人的自我测试。为了应对这些重大挑战， Sanguina公司开发了一种新颖的，多方面的贫血筛查和监测产品套件 包括3个主要产品1）AnemoCheck家庭使用-“一滴血”手指针刺测试， 我们的FDA批准的技术可以引起与Hgb水平相关的颜色变化，2）AnemoCheck移动的- a 智能手机应用程序，仅使用智能手机照片和手机的本地硬件筛选贫血症， 3)AnemoCheck My移动的，家庭和移动的产品的结合，其中应用程序使用 AnemoCheck血液测试，以显着提高应用程序的准确性和个性化的血红蛋白水平的结果。这些 这些技术已经发表在高影响力的同行评审期刊上（Tyburski等人，JCI 2014，Mannino et 等人，Nature Communications 2018）。第二阶段SBIR的目标是完成AnemoCheck MyMobile， Sanguina利用了智能手机的普及和基于手指采集的自我测试的熟悉程度 根据需要，开发一个范式转变平台，用于在家管理贫血和保持健康， 贫血风险最高的人群。本阶段II SBIR的目标是验证AnemoCheck MyMobile平台用于管理慢性贫血患者的贫血，该平台是利用阶段开发的 I SBIR资助。我们将利用我们与共同PI和共同I的Robert Sidonio，MD，Wilbur Lam，MD， 埃默里大学医学院的Traci Leong博士对一个队列进行临床验证 出血性疾病、溶血性贫血、镰状细胞病和血红蛋白病患者的慢性贫血， 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， 通过以下拟议目标监测贫血1）个性化AnemoCheck移动的，以创建AnemoCheck MyMobile用于慢性贫血患者，2）将AnemoCheck MyMobile作为个性化系统， 慢性贫血管理