Novel Urine Collection Kit for Obstructive Sleep Apnea

PROJECT SUMMARY This Phase I STTR project is a collaboration between PGXL Technologies, LLC (Company) and the University of Louisville Research Foundation (University) to develop an innovative urine collection kit used to detect obstructive sleep apnea (OSA) in patients. PGXL Technologies is developing a US-Patented, non-invasive urine-based assay for obstructive sleep apnea (OSA) in children. The test is comprised of a panel of four protein biomarkers detected in urine. OSA occurs in up to 3% of children and as much as 10% of the pediatric orthodontic population including 7% in adults. OSA can lead to disturbed sleep, neurobehavioral problems, neurocognitive impairments, and hypertension in children and adults. Diagnosis is primarily limited to in-clinic sleep studies because patient history and physical examinations are not adequately able to differentiate OSA from primary snoring (PS). Polysomnography (PSG) tests are administered in sleep studies and are the gold standard for diagnosis, but they are highly expensive, require an overnight stay in a supervised sleep clinic, are difficult for children as well as adults, and do not meet the need for efficient screening for OSA. There is only one at-home sleep diagnostic that has been cleared by the FDA for use in children and it requires attachment of wires and sensors overnight, which is challenging to implement with children. There is an unmet need for a rapid and sensitive test for OSA that can be used for potential diagnosis, patient monitoring as they undergo treatment, and screening of broader populations. The Company is developing an immunoassay-based multiplex panel comprised of four proteins (uromodulin, urocortin-3, orosomucoid-1, and kallikrein) associated with stress and hypoxia detected in the urine of children with OSA. Preliminary published data indicates that this set of markers provides a diagnostic sensitivity of 100% and specificity of 96.5% for OSA in children. To confirm the efficacy of this test-panel with controlled studies we will require shipping of urine samples to our testing facility after collection. Securing the integrity of the proteins during shipping and storage is essential to our success. To address this challenge there is an imminent need to develop a simple yet rigorous process for stabilizing the proteins during specimen transport. In this Phase I STTR project we will use an innovative silica-based reagent (BioCaRGOS) developed by our team and demonstrate that the reagent is compatible with our immunoassay system and stabilizes the target proteins in urine under shipping conditions. This proof-of-concept will enable the design of a rigorous urine collection kit required for our Phase II clinical studies. Completion of these goals will enable advancement toward a laboratory developed test using a novel method for stabilizing and processing of urine samples needed for routine collection and provide an approach towards FDA clearance of a multiplexed high throughput assay for OSA. Commercialization of these products will enable delivery of a critically needed rapid test that can be administered by PGXL Technologies or licensed to CLIA-certified clinical labs. This will fill a need for rapid, sensitive, and cost-effective identification of OSA in children and adults.