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

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.Project Narrative Commercializing a blood test that differentiates epileptic seizures from psychogenic non- epileptic seizure is a complex and necessary endeavor. Evogen’s commercialization team has made significant progress in establishing that enthusiastic demand exists for such a test among patients and healthcare professionals, and seeks to build on this foundation by better exploring and understanding how hospital systems and payors are likely to receive and reimburse the test.