Parent Project Abstract 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 (5?L) 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 (40-60C) 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.
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.