An at-home test for chronic kidney disease

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PROJECT SUMMARY Chronic kidney disease (CKD) is a major global public health problem. The early stages of CKD usually do not present clear symptoms, and, as a result, as many as 9 in 10 affected adults are unaware of their condition. This translates to approximately 30 million undiagnosed CKD cases in the US alone. End-stage renal disease (ESRD) is an outcome of undiagnosed and untreated CKD, requiring costly renal-replacement therapy in the form of dialysis or transplantation and resulting in $114 billion in healthcare spending in the US each year. While routine screening of patients who are at risk for developing CKD (e.g., patients with hypertension or diabetes), this strategy is costly and inconvenient, requiring multiple clinic visits for testing to accurately diagnose the disease. However, proper diagnosis of CKD requires only two simple tests: a urine albumin to creatinine ratio (ACR) test to look for albumin in the urine, indicative of kidney damage, and a serum creatine to estimate the glomerular filtration rate (eGFR). The prolonged elevation of these two parameters can be used to effectively identify patients with CKD and direct them for follow-up with a physician for treatment. Scanwell Health is a digital healthcare company delivering simple and affordable access to in vitro diagnostic testing. The company aims to provide scalable diagnostics for healthcare companies and accurate, at-home testing for everyone. Scanwell is developing a CKD Test that enables simple, accurate, and cost-effective assessment of kidney function in a kit that can be self-administered by the patient in an at-home environment. The test is a comprehensive, user-friendly kit designed to work in conjunction with a smartphone app, allowing proactive monitoring of renal health. Extensive preliminary data demonstrates accurate and repeatable laboratory measurements of urine albumin, urine creatinine, and serum creatinine using a smartphone app to read the results. Here we propose a series of clinical studies to validate the usage of Scanwell’s Urine ACR and Serum Creatinine Test Kits in the hands of lay users. Demonstration of accurate results when the test is self-administered is critical to the value proposition of the product, enabling much lower test costs and facilitating more frequent monitoring without the need for clinic visits. As a first step, we will assess the overall usability in the hands of lay users, assessing kit design, clarity of the instructions, ease of completing the test, satisfaction with the ability to use the product, and patient confidence in the test results. We will follow this with studied benchmarking the performance of the two test components (Urine ACR and Serum Creatinine) to current standard, FDA-cleared clinical tests administered by a healthcare professional. Successful demonstration of accurate results and excellent ease of use will allow for more widespread CKD screening, and enable earlier diagnosis and more efficient monitoring. This will lower the cost burden of CKD on the healthcare system and lead to improved patient outcomes.