Trial Will Assess Blood-Based Biomarker to Distinguish Epileptic From Psychogenic Seizures

December 15, 2019

A new trial will aim to confirm the findings of a previous study that showed novel combinations of peripherally circulating proteins coupled with risk factors can provide a diagnostic tool with significant clinical unity.

Todd Wallach

Cognizance Biomarkers recently announced the launch of a new clinical trial with Mayo Clinic that aims to confirm the accuracy and utility of its blood-based protein biomarker and algorithm test to accurately distinguish epileptic seizures (ES) from psychogenic nonepileptic seizures (PNES). The clinical trial is funded by a recently awarded grant from the National Institute of Neurological Disorders and Stroke.1

“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,” Todd Wallach, CEO of Evogen/Cognizance Biomarkers, said in a statement.1 “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.”

At the 2018 American Epilepsy Society Annual Meeting, Cognizance Biomarkers presented results from a clinical study that effectively distinguished the differences between ES and PNES with sensitivity and specificity using their protein biomarker test and algorithm.2 Evogen, the parent company of Cognizance Biomarkers, used their novel diagnostic technology to determine protein concentrations derived from blood samples collected within 24 hours of an event.2

READ MORE: Automated Monitoring Systems May Distinguish Epileptic From Psychogenic Seizures

The trial assessed the blood of 31 patients with ES and 9 patients with PNES admitted to the epilepsy monitoring unit (EMU) for definitive diagnosis or surgical evaluation. Investigators assessed blood samples taken each morning and within 24 hours of a clinical event captured by EEG video. They located and assayed 51 different proteins across 6 multiplex ELISA panels and quantitated them using the Meso Scale Discovery Platform, an electrochemiluminescent detection system.

Results from the study revealed predictive scores from plasma protein levels and PNES risk factors among patient groups. In total, 8 proteins with significant differences in mean plasma concentrations between ES and PNES were observed (P <.05). Additionally, investigators found that proteins IL-16, ICAM-1, TRAIL, MIP-1ß and the sum of PNES risk factors can lead to a better understanding of the differences between ES and PNES.

A reported 20% to 40% of patients seeking medical care at epilepsy centers have PNES, however current diagnostic methods for PNES are flawed and can contribute to healthcare cost increases and inpatient care.

REFERENCE

1. Cognizance biomarkers initiates clinical trial to confirm its test can distinguish epileptic seizures from psychogenic nonepileptic seizures [news release]. Spring House, PA. Evogen/Cognizance Biomarkers. December 4, 2019. prnewswire.com/news-releases/cognizance-biomarkers-initiates-clinical-trial-to-confirm-its-test-can-distinguish-epileptic-seizures-from-psychogenic-nonepileptic-seizures-300968902.html. Accessed December 12, 2019.

2. Gledhill JM, Brand E, St. Clair R, et al. Predictive blood test for psychogenic nonepileptic seizures: post hoc assessment of plasma biomarkers and risk factors. Presented at 2018 American Epilepsy Society Annual Meeting. November 30-December 4, 2018; New Orleans, LA.