Epilepsy affects approximately 1% of the world population, totaling >50 million patients. While anti-epileptic drug (AED) treatment is successful in many patients, 40-70% of patients continue to experience seizures causing physicians to adjust/change medications or other treatment parameters. Current diagnostic tools are incapable of differentiating between patients experiencing a recent seizure and those who are either seizure free or experiencing non-seizure events. Complicating matters, patients frequently under-report seizures in self-reported seizure diaries. To aid physicians in assessing the current state of seizure control in epilepsy patients, Evogen is developing a diagnostic test to distinguish epilepsy patients who have recently experienced a seizure from those who have not. Towards developing this test, Evogen has identified and patented a unique combination of 5 proteins that stratify actively seizing patients from those who have not experienced a recent seizure. To confirm the previous results, Evogen will first measure the plasma levels of 5 target proteins in powered cohorts of patients using validated ELISA run on the Meso Scale Discovery platform. Mean protein concentration will be calculated and cohorts compared to determine if significant differences exist. Subsequently, we will combine the 5 target protein levels into a diagnostic algorithm, toward the goal of achieving a diagnostic output of a single âseizure probability score.â We recognize that ideal diagnostic results are concise and simple (ideally just one number or a yes/no) so a physician can quickly interpret and appropriately act. Both descriptive statistic results and algorithm performance will be used to determine the success of this effort. The test will have a profound impact on diagnosis and treatment of epilepsy. Future applications to support patient care throughout the life of the patient include identifying initial seizures and identifying potential refractory patients. Also, the test will serve to bolster drug development and clinical trial success by ensuring the right types of patients are enrolled and provide an objective clinical endpoint.
Public Health Relevance Statement: Project Narrative Epilepsy actively affects approximately 1% of the world population, totaling 50 million patients. Current tools to diagnosis if epileptic patients recently had a seizure have limited performance, high costs and limited availability. A diagnostic test that indicates if a patient recently experienced a seizure would provide physicians with objective, actionable data that can result in improved clinical care, patient outcomes and healthcare system savings.
NIH Spending Category: Brain Disorders; Epilepsy; Neurodegenerative; Neurosciences
Project Terms: Affect; Age; Algorithms; Antiepileptic Agents; base; Biological Assay; Blood; CCL17 gene; CCL2 gene; CLIA certified; Clinical; clinical care; Clinical Research; Clinical Trials; cohort; cost; Data; Development; Diagnosis; Diagnostic; diagnostic assay; Diagnostic Sensitivity; Diagnostic tests; diaries; drug development; Electroencephalography; Enrollment; Ensure; Enzyme-Linked Immunosorbent Assay; Epilepsy; Event; experience; Future; Gender; Goals; Healthcare Systems; Human; improved; Individual; Inflammation; Inflammatory; Interleukin-16; Laboratories; Legal patent; Life; Measures; Medical; Monitor; Motor; Neurologic; Neurologist; novel diagnostics; off-patent; Output; Patient Care; Patient Self-Report; Patient-Focused Outcomes; Patients; Performance; personalized medicine; Pharmaceutical Preparations; Pharmacotherapy; phase 2 study; Physicians; Plasma; Plasma Proteins; Population; Probability; Proteins; Recording of previous events; Refractory; Reporting; Running; Sampling; Savings; Seizures; Single Seizures; Source; Specificity; statistics; success; Symptoms; Testing; Time; TNF gene; tool; Vascular Cell Adhesion Molecul
