A Non-invasive Assay for Obstructive Sleep Apnea

项目摘要 PGXL技术公司正在开发一种新的基于尿液的检测阻塞性睡眠呼吸暂停的方法 (OSA)小儿阻塞性睡眠呼吸暂停（OSA）是一种引起行为和学习障碍的疾病 问题，包括误诊为儿童注意力缺陷多动障碍（ADHD）。的 CDC估计美国儿童OSA的患病率为3% -约230万。一个额外 并发症是儿童原发性打鼾（PS）的患病率接近20%，因此 医生在区分OSA和PS方面面临挑战。诊断的“黄金标准”测试 儿童OSA是多导睡眠图（PSG），但它是昂贵的（每次测试高达1,200美元），涉及 在睡眠实验室中过夜，并且需要放置许多传感器。父母 通常不愿意--孩子们也太不合作--忍受PSG测试。带回家的睡眠设备 允许患者在家中监测他们的睡眠模式，但不适用于儿童。因此， 并且便宜的尿液测试将满足重要且显著的临床需求。初探 通过比较多导睡眠图诊断为OSA的儿童与PS儿童， 尿皮质素3肽（UCN 3），一种应激相关的生物标志物， 儿童OSA我们有一个美国专利，使用UCN 3作为生物标志物， OSA和还开发了一种基于质谱的测定和免疫测定来测量 UCN 3。为了完成确定性研究，验证使用该方法的临床灵敏度和特异性， 作为OSA的诊断生物标志物，有必要进行稳健的CLIA验证和标准化 检测试剂盒-目前不可用。在第一阶段项目完成后，我们将优化质量 CLIA验证标准品的光谱测定，包括建立初步参考范围 尿液中的UNC 3。该项目的成功完成将使我们公司进入第二阶段 严格开发免疫测定和临床验证UCN 3作为生物标志物的项目 用于检测OSA。该项目在应用新型生物标志物检测 儿童OSA和使用新的提取方法测量UCN 3。具有健壮 用于检测OSA的检测方法预计将在重大且多方面产生可持续的高影响。 诊断儿童睡眠呼吸暂停所需的临床问题。这将提供可持续的 PGXL技术的商业化途径，以开发简单，廉价的临床试验 实验室通过测定试剂盒以及护理点和其他体外诊断应用。

Project Abstract PGXL Technologies is developing novel urine-based tests for detecting obstructive sleep apnea (OSA) in children. Obstructive sleep apnea (OSA) is a disorder giving rise to behavioral and learning problems, including misdiagnoses as attention deficit hyperactivity disorder (ADHD) in children. The CDC estimates the prevalence of pediatric OSA in the US at 3% - around 2.3 million. An added complication is that the prevalence of primary snoring (PS) in children approaches 20%, thus physicians are challenged in differentiating OSA from PS. The “gold standard” test for diagnosing OSA in children is polysomnography (PSG), but it is expensive (up to $1,200 per test), involves an overnight stay in a sleep laboratory, and requires the placement of numerous sensors. Parents are often unwilling – and children too uncooperative – to endure a PSG test. Take-home sleep devices allow patients to monitor their sleep patterns at home, but are not available to children. Thus, a simple and inexpensive urine test would fill an important and significant clinical need. A preliminary study comparing children diagnosed with OSA by polysomnography to children with PS revealed that the peptide urocortin 3 (UCN3), a stress-related biomarker, was significantly increased in the urine of children with OSA. We have an issued US patent for the use of UCN3 as a biomarker for detecting OSA and have also developed a mass spectrometry-based assay and an immunoassay to measure UCN3. To complete definitive studies validating the clinical sensitivity and specificity of using this biomarker as a diagnostic for OSA, it is necessary to have robust CLIA-validated and standardized assays - not available today. Upon completion of this Phase I project, we will have optimized a mass spectrometry assay to CLIA-validated standards including establishing preliminary reference ranges for UNC3 in urine. Successful completion of this project will position our company for a Phase II project to rigorously develop immunoassays and clinically validate the use of UCN3 as a biomarker for detection of OSA. This project is innovative in the application of a novel biomarker for detection of OSA in children and in the use of novel extraction methods for measuring UCN3. Having robust assays for detection of OSA is anticipated to have sustainable high impact in a significant and much needed clinical problem of diagnosing sleep apnea in children. This will provide a sustainable commercialization path for PGXL Technologies to develop simple and inexpensive assays for clinical laboratories by way of assay kits as well as point-of-care and other vitro diagnostics applications.