NextUp: The Company Improving Epileptic Seizure Diagnosis

Cognizance has developed a diagnostic test to accurately detect the difference between seizures and other commonly misdiagnosed neurological conditions.

Todd Wallach is the president and chief executive officer of Cognizance Biomarkers, a subsidiary of Evogen.

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Who: Cognizance Biomarkers, a molecular diagnostics company, originated at the University of Pennsylvania where two neurologists, Peter Crino and John Pollard, set out to build diagnostic tools for their clinical practice. Crino and Pollard often saw patients who had experienced some type of transient neurological event, but they lacked a subjective way to make a definitive diagnosis. The two explored the hypothesis that inflammation is both a cause and consequence of epileptic seizure and ran a pilot study to evaluate inflammation associated biomarkers in patients with recent seizures. The study results allowed for accurate identification and separation of patients with and without seizures and led the founders to patent the technology and formally launch the company in 2012.

Cognizance operates as a subsidiary of Evogen, a global developer of diagnostic, detection and sample collection solutions. The company’s headquarters are located at Spring House Innovation Park, a local hub for life science and biotech companies.

What: Cognizance has developed a blood-based protein test with associated diagnostic algorithms that use artificial intelligence and machine learning to determine whether a patient has experienced an epileptic seizure. The test quickly provides accurate results that enable physicians to ensure the right patients undergo a neurology workup and associated care. Those who have not experienced an epileptic seizure are directed elsewhere for further evaluation by the appropriate specialty.

“Our first blood test enables epilepsy to be diagnosed and treated more rapidly and accurately. This approach has the potential to empower physicians to more effectively manage their epilepsy patients’ treatment over time, as well as to inform new drug clinical development,” said Todd Wallach, president of Cognizance. “We look forward to advancing our proteomic tools for addressing major unmet needs in epilepsy diagnosis and management through further clinical development to full commercialization.”

When: In April 2019, Cognizance received a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to collaborate with the Human Epilepsy Project (HEP) and expand the utility of the company’s diagnostic test to better understand seizure test results. In 2021, Cognizance plans to launch EvoScoreDX to screen adult patients with suspected seizures.

Why: Epilepsy is the fourth most common neurological disorder that afflicts more than 65 million people worldwide. More than one million patients in the U.S. visit emergency rooms or primary care offices each year reporting seizure-like events, but only a fraction of those events are actual 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 since 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 percent of cases which confirms the presence of seizures and epilepsy. The remaining 80 percent 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) and, where available, inpatient hospitalization for continuous video-EEG monitoring.

What It Means: Epilepsy diagnosis is extraordinarily difficult, expensive and often remains subjective. Patients need a better path to an accurate diagnosis. Cognizance’s diagnostic test could result in a major shift in the way we diagnose epileptic seizures and may ultimately result in improved patient outcomes, better epilepsy management and significant cost savings to the healthcare system.