STTR Phase I: Development of a novel patient-operated, color-based, disposable diagnostic self-test for anemia

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is high and focuses on optimizing an inexpensive, disposable, home-based self-test for anemia that can potentially serve millions of people in the U.S. suffering from anemia, including patients with blood diseases, chronic kidney disease, HIV/AIDS, cancer, and inflammatory diseases.. This screening and monitoring test for anemia can be performed in under a minute, with one drop of blood and produces a color result that can be interpreted by the naked eye. The colors correlate to the degree of anemia, if any and range from blue to red. While the colors are easily differentiated from one another and can be interpreted without any additional electronic equipment an optional smartphone app can be used to enable automated analysis, if desired. Overall, this simple, anemia self-test, can enable patients with chronic anemia to monitor their own disease and to guide their medication dosing, the general public to screen for themselves for anemia, and clinicians in resource-poor settings to inexpensively diagnose anemia, which is currently cost-prohibitive with current technologies. The proposed project will comprise optimization of our chemical solution for accuracy and increased shelf life via chemometric experimentation, with the goal of extending shelf life to over 12 months. The project will also assess the potential interference of common drugs and their metabolites across physiologic and non-physiologic ranges that are commonly prescribed to the target patient populations. Additionally, the physical device will be 3D printed and optimized for ease of use by the user (with or without the smartphone app) while minimizing cost of materials and manufacturing. These deliverables will enable an FDA submission necessary for commercialization.