NEW YORK — Evogen's Cognizance Biomarkers subsidiary has launched a clinical trial with Mayo Clinic to validate its proteomic test for distinguishing between epileptic seizures and psychogenic non-epileptic seizures (PNES).
The company has received IRB approval from Mayo and plans to begin enrolling patients within the next several weeks, said Todd Wallach, president and CEO of Cognizance. He said that the trial aims to enroll 216 patients over the next year, with the primary goal of the study being to finalize the test's protein marker panel and algorithm.
Wallach said that the company aims to bring the test to market in early to mid-2021.
The trial is supported by a $562,119 Small Business Innovation Research grant Evogen received last year. In April, the company received an additional $224,515 SBIR grant that it is using to develop a protein panel for distinguishing patients who have had a recent seizure from those who have not.
The ultimate goal of the test being developed through the Mayo trial is to rule out patients without epilepsy, Wallach said, allowing for doctors to more quickly move these patients into appropriate treatment.
According to Evogen, some 20 percent to 40 percent of patients seeking medical care at epilepsy centers actually have PNES, which are caused not by the electric disturbances underlying epilepsy but, rather, by psychological factors.
Distinguishing between the two conditions can be difficult, though, Wallach noted, citing literature reviews that he said "indicate that it can take as much as seven to 10 years to correct an initial epilepsy misdiagnosis, during which time the patient is subjected to treatment not meant for their individual disease."
Cognizance was originally launched by Peter Crino – formerly a researcher at the University of Pennsylvania and currently chair of neurology at the University of Maryland School of Medicine – and John Pollard, director of the Christiana Care Epilepsy Center and adjunct associate professor of neurology at Penn's Perelman School of Medicine who formed the company to commercialize three protein markers they had linked to epilepsy.
Evogen purchased Cognizance in 2016 and originally planned to launch its epilepsy test as a laboratory-developed test in 2017. However, feedback from potential customers convinced the firm to work to improve the test's diagnostic performance before launching.
In 2017, the company presented data at the American Epilepsy Society annual meeting in which they measured 51 plasma proteins in 31 patients with confirmed epilepsy and 29 normal controls, arriving at a seven-marker panel that could distinguish between the two groups with sensitivity of 100 percent and specificity of 90 percent.
In 2018, Evogen and collaborating researchers presented data at the AES meeting that looked at 31 patients with epilepsy, 29 normal controls, and 9 patients with PNES and found that a four-protein panel along with known PNES risk factors was able to distinguish between epilepsy and PNES patients with sensitivity of 93.5 percent and specificity of 100 percent.
The Mayo trial will test these findings in a larger cohort.
Wallach said that he company is also in the process of seeking additional sites to expand the study.
Separate from the Mayo trial, Evogen is looking at potential sites for trials investigating its protein panel for identifying patients who have had seizures recently. Such a test could prove useful for helping doctors monitor how well controlled a patient's seizures are and adjust anti-seizure therapies if necessary.
In May, the company presented at the Antiepileptic Drug and Device Trials XV Conference findings from studies looking at panels for monitoring seizure burden derived from the same 51 plasma proteins used to develop the PNES test. In these studies, the company identified a set of five plasma proteins that appear useful for seizure monitoring, which it plans to test further using the Small Business Innovation Research grant it received earlier this year.