SPRING HOUSE, Pa., Dec. 4, 2019 /PRNewswire/ -- Cognizance Biomarkers, LLC, a wholly-owned subsidiary of Evogen, Inc., a leader in proteomic and genomic-based testing for improved diagnosis and treatment of neurological disorders, today announced initiation of a clinical trial with Mayo Clinic that aims to confirm its blood-based protein biomarker test and algorithm accurately distinguish epileptic seizures (ES) from psychogenic nonepileptic seizures (PNES). The trial is supported by a recently awarded grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Number R43NS113724.
The new clinical trial is intended to confirm the results of a clinical study reported at the 2018 Annual Meeting of the American Epilepsy Society, which showed that the protein biomarker test and algorithm accurately distinguished ES from PNES with sensitivity and specificity. Gregory D. Cascino, MD, FAAN, the Whitney MacMillan, Jr. Professor of Neuroscience at Mayo Clinic College of Medicine and Science and the Enterprise Director of Epilepsy at Mayo Clinic, is Principal Investigator of the new trial.
Todd Wallach, CEO of Evogen/Cognizance Biomarkers commented, "We are delighted to initiate this clinical trial with Dr. Cascino at Mayo Clinic. Misdiagnosis of epilepsy is common and has substantial health, social and economic costs. Current methods for distinguishing epilepsy from the many types of nonepileptic seizures are slow, costly and often subjective. We are excited to work with Mayo Clinic as part of our commitment to supporting improved diagnostic options for the management of patients experiencing seizures."
Epilepsy is currently diagnosed using electroencephalograms (EEGs), video EEGs and comprehensive patient assessments. The process is widely viewed as slow, subjective, cumbersome and expensive. Cognizance Biomarkers' simple-to-administer EvoScoreDX blood test aims to accurately diagnose epileptic seizures based on proprietary methods that assess selected neuroinflammatory biomarkers.
PNES account for a significant percentage (a reported 20%-40%) of patients seeking medical care at comprehensive epilepsy centers. Although hard to distinguish from true epileptic seizures, PNES result from psychological factors rather than the electrical disturbances in the brain that cause epilepsy. Individuals with PNES are often assumed to have epilepsy and receive unnecessary testing and treatment, including antiepileptic drugs, while their underlying psychological disorders remain untreated.
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and more than 3 million people in the U.S., where it is the fourth most common neurological disorder. Although epilepsy may be linked to factors such as health conditions, race and age, it can develop in anyone at any age. The main characteristic of the condition is recurrent seizures caused by electrical disturbances in the brain. The accurate diagnosis of epilepsy remains a challenge as current diagnostic methods are subjective, cumbersome, expensive and imprecise.
Evogen, Inc. is a leading developer of diagnostic, detection and sample collection solutions with successful products deployed worldwide. Cognizance Biomarkers LLC, a wholly owned subsidiary of Evogen, is a neurology and neuroinflammation-focused diagnostics company focused on achieving leadership in proteomic and genomic-based testing for improved diagnosis and treatment of neurological disorders, offering rapid, accurate and cost-effective precision medicine solutions for optimal patient outcomes. Cognizance Biomarkers' patented EvoScoreDX biomarker-based blood test has the potential to revolutionize the diagnosis of epilepsy. In clinical trials, EvoScoreDX demonstrated sensitivity of 100% and specificity of 90%. The company is also developing comprehensive genomic testing for improved management of neurological disorders. For more information, visit cognizancebiomarkers.com.
SOURCE Evogen/Cognizance Biomarkers