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

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 实际癫痫发作，有许多不同类型的癫痫发作和不同的综合征 演示文稿。此外，其他神经系统疾病可能是癫痫发作的模仿物，导致错误 诊断、具有重大潜在不良事件的不适当治疗、不正确的预后以及 严重浪费医疗资源。被误认为癫痫的主要症状是心理原因。 非癫痫发作(PNES)，即使是经验丰富的临床医生也经常误诊。患者 遭受PNES事件经历类似于癫痫发作但不是由 大脑中异常的、同步的电活动。明确诊断为PNES或 癫痫对患者的长期健康和预后至关重要。目前，正在获得明确的诊断 癫痫或PNES对患者来说既昂贵又不方便，因为它可能需要住院评估和 一系列昂贵的测试。为了解决这一未得到满足的需求，Evogen的谓词SBIR建议进一步开发 准确的诊断血液测试，可用于将暂时性神经事件分层为PNES或PNES 癫痫。这项工作将包括收集更多的患者样本以确认试点结果。在确认后， 已创建简化的开发计划，以收集CLIA所需的所有信息 并将该测试推向市场。 与科学发展同步，Evogen制定了初步的商业化计划，并以此为基础-- 兵团行政副刊我们建议打造全面、有效、多方面的 商业化和推出计划。我们之前的市场研究已经确定，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。在一项有115人参与的调查中 医生中，97%的人报告说，他们很可能会将这项测试作为诊断工作的一部分 疑似癫痫患者。Evogen急于开始我们的商业化计划的下一步， I-Corps项目的赞助。具体地说，我们希望获得必要的工具，以彻底 了解我们不同的客户群体，其中不仅包括患者和医疗提供者，还包括 医疗保健系统和付款人。为此，我们将展开广泛的研究，研究后两者如何 特别是集团将收到我们的产品，并测试我们最初的药物经济学研究定价和 报销。

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.