Assessment of Peripherally Circulating Plasma Proteins and Clinical Risks toDifferentiate Epileptic Seizure from Psychogenic Nonepileptic Seizure

评估外周循环血浆蛋白和区分癫痫发作和心因性非癫痫发作的临床风险

• 批准号: 10044988
• 负责人: John Gledhill
• 金额: $ 5.5万
• 依托单位: EVOGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-24 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10044988
• 关键词: Address; Administrative Supplement; Adverse event; Blood Tests; Brain; CLIA certified; Complex; Consumption; Development; Development Plans; Diagnosis; Diagnostic; Epilepsy; Evaluation; Event; Foundations; Health; Health Professional; Healthcare; Healthcare Systems; Hospitals; Innovation Corps; Inpatients; Market Research; Medical; Neurologic; Outcome; Patient Care; Patients; Peripheral; Pharmaceutical Economics; Physicians; Plasma Proteins; Price; Provider; Reporting; Research; Resources; Sampling; Seasons; Seizures; Small Business Innovation Research Grant; Surveys; Syndrome; System; Testing; Time; Work; accurate diagnosis; clinical risk; commercialization; cost; experience; nervous system disorder; programs; tool; wasting

Abstract Accurately diagnosing epilepsy is very challenging and time consuming because clinicians rarely observe the actual seizure, and there are many different types of seizures and epilepsy syndromes with differing presentations. Furthermore, other neurological disorders can be mimics of seizures leading to erroneous diagnosis, inappropriate treatments with significant potential adverse events, incorrect prognoses, and significant waste of healthcare resources. A primary indication that is mistaken for epilepsy is psychogenic non-epileptic seizure (PNES) which is commonly misdiagnosed even by seasoned clinicians. Patients that suffer PNES events experience convulsive events which are similar to epileptic seizures but do not arise from aberrant, synchronous, electrical activity in the brain. Rendering a definitive diagnosis of either PNES or epilepsy is critical to long-term patient health and outcome. Currently, obtaining a definitive diagnosis of epilepsy or PNES is expensive and inconvenient for patients as it may require inpatient evaluation and a battery of costly tests. To address this unmet need Evogen’s predicate SBIR proposes to further develop an accurate diagnostic blood test that can be used to stratify transient neurological events as either PNES or epilepsy. This work will include collecting additional patient samples to confirm pilot results. Upon confirmation, a streamlined development plan has been created to collect all of the information required for CLIA accreditation and bring the test to market. In tandem with scientific development, Evogen has developed an initial commercialization plan and with this I- Corps administrative supplement we propose to create a comprehensive, effective, and multi-faceted commercialization and launch plan. Our previous market research has established that patients and health care professionals are overwhelmingly enthusiastic and ready to embrace such a test. In a survey of 115 physicians, 97% reported that they would be a “very likely” to use the test as part of their diagnostic workup for suspected epilepsy patients. Evogen is eager to embark on the next step of our commercialization plan under the auspices of the I-Corps program. Specifically, we hope to gain the tools necessary to thoroughly understand our varied groups of customers, which consists not only of patients and medical providers, but also healthcare systems and payors. To this end, we will embark on extensive research about how the latter two groups in particular will receive our product, and test our initial pharmacoeconomic research on pricing and reimbursement.

摘要 准确诊断癫痫是非常具有挑战性和耗时的，因为临床医生很少观察到癫痫发作。 癫痫发作的类型有很多种，癫痫发作的类型也有很多种。 介绍。此外，其他神经系统疾病可能是癫痫发作的模拟，导致错误的诊断。 诊断、不适当的治疗与重大潜在不良事件、不正确的诊断，以及 严重浪费医疗资源。被误认为癫痫的主要指征是心因性的 非癫痫性发作（PNES），即使是经验丰富的临床医生也经常误诊。的患者 发生PNES事件的患者经历类似于癫痫发作的惊厥事件，但不是由 异常的同步的脑电活动明确诊断为PNES或 癫痫对患者的长期健康和结果至关重要。目前，获得明确的诊断， 癫痫或PNES对患者来说是昂贵和不方便的，因为它可能需要住院评估， 一系列昂贵的测试。为了解决这一未满足的需求，Evogen的同品种器械SBIR提议进一步开发 准确的诊断性血液检查，可用于将一过性神经系统事件分层为PNES或 癫痫这项工作将包括收集额外的患者样本，以确认试点结果。一经确认， 已经制定了一个简化的发展计划，以收集CLIA所需的所有信息 认证并将测试推向市场。 随着科学的发展，Evogen已经制定了初步的商业化计划，并与此我- 兵团行政副刊我们建议创建一个全面的、有效的、多方面的 商业化和启动计划。我们之前的市场调查已经确定，患者和健康 护理专业人员非常热情，并准备接受这样的测试。在115项调查中， 97%的医生报告说，他们“很有可能”使用该测试作为诊断检查的一部分， 疑似癫痫患者Evogen渴望开始我们商业化计划的下一步， I军团项目的赞助具体来说，我们希望获得必要的工具， 了解我们不同的客户群体，不仅包括患者和医疗提供者， 医疗保健系统和付款人。为此，我们将展开广泛的研究，探讨后两者如何 特别是将收到我们的产品，并测试我们的初步药物经济学研究的定价和 报销