Cognizance Biomarkers is answering the question: “Did you have a seizure?”

Cognizance Biomarkers, LLC, a molecular diagnostics company, originated at the University of Pennsylvania where two neurologists, Peter Crino and John Pollard set out to build diagnostic tools to aid their clinical practice. Frequently they would see patients who had some type of transient neurological event, but no subjective way to make a definitive diagnosis. To this end, the two leveraged a hypothesis that inflammation is both a cause and consequence of epileptic seizure and ran a pilot study to evaluate inflammation associated markers in patients with recent seizures. The study’s results were profound; evaluating modulations in a set of biomarkers allowed for perfect separation of patients with and without seizures. The exciting results lead to patenting the technology and working with UPenn’s UPstart program to found Cognizance Biomarkers. Cognizance Biomarkers was able to secure funding through an NIH sponsored SBIR, the results of which eventually lead to the acquisition of Cognizance Biomarkers by Evogen.  Cognizance is proposing a revolutionary shift in the diagnosis of epileptic seizures that will allow for rapid stratification, identification and treatment of patients who experienced an epileptic seizure, yielding improved patient outcomes, epilepsy management and significant cost savings to the healthcare system.

Epilepsy is the fourth most common neurological disorder that afflicts >65 million people worldwide. Greater than 1 million patients in the US present annually to emergency rooms or primary care settings reporting seizure-like events, but only a fraction of those events are actually epileptic seizures, as characterized by the occurrence of abnormal synchronized electrical activity in the brain. Epilepsy diagnosis is a long, expensive, and unreliable process requiring months to years of testing and evaluation. Diagnosis of epilepsy often remains subjective even after an extensive workup as it is difficult to differentiate seizures from other transient neurological events. Currently available diagnostic options lack conclusive results even after a combination of tools have been utilized, including the diagnostic gold standard electroencephalogram (“EEG”). An initial EEG is only positive in approximately 20% of cases which confirms the presence of seizures and epilepsy. The remaining 80% of patients have negative EEGs, which are often considered inconclusive and lead to additional diagnostic workup including: CT and MRI scans, trials of anti-epileptic drugs (“AEDs”) given empirically, and, where available, inpatient hospitalization for continuous video-EEG monitoring. Needless to say, diagnosis is extraordinarily difficult, wastefully expensive and often remains subjective. All patients need a better, objective, and actionable diagnostic pathway.

Cognizance’s diagnostic test, EvoScoreDX™, is a blood-based proteomic test with associated diagnostic algorithms (developed via artificial intelligence and machine learning) with an AUC of 0.95, and sensitivity and specificity up to 100% and 90%, respectively to determine if a patient experienced an epileptic seizure. It will provide rapid, clear, objective, and actionable results, ensuring the right patients undergo a neurology workup and associated care, and that those who have not experienced an epileptic seizure are directed elsewhere for further evaluation by the appropriate specialty.

Cognizance plans to initially launch EvoScoreDX as a Laboratory Developed Test (“LDT”) in 2021 to screen adult patients, ages 18 and above, presenting with a suspected seizure; a negative result rules out seizure, while a positive result directs the patient to continue with a neurology assessment and care. Future label expansion opportunities for EvoScoreDX include patient management of seizures and epilepsy, seizure prediction; AED clinical trial eligibility, endpoints, and effectiveness; companion diagnostics; and potential identification of inflammation-based therapeutics and response. Cognizance has broad and granted IP coverage that protects and encompasses the novel biomarkers and associated diagnostic algorithms for applications in epilepsy and other neurological conditions.