Evogen's Cognizance Strengthens Intellectual Property Portfolio with Issuance of New U.S. Patent for Its Diagnostic Biomarkers for Epilepsy

PHILADELPHIA, Oct. 10, 2018 /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 that the U.S. Patent and Trademark Office (USPTO) has issued a new patent providing further protection for its novel neuro-inflammatory biomarkers for the diagnosis, management and treatment of epileptic seizures. U.S. Patent 9,772,335 is owned by the University of Pennsylvania and exclusively licensed to Cognizance. This is the second issued patent covering methods for detecting seizures and assessing the effectiveness of treatments for seizures using neuro-inflammatory biomarkers. These patents, which are based on seminal work by Drs. Peter Crino and John Pollard, leading scientists in the field of neuro-inflammation, form the core of Cognizance's broad intellectual property portfolio.

"This new patent confirms our strategy of working closely with our academic colleagues to expand the patent protection for our novel neuro-inflammatory biomarkers for the diagnosis of epileptic seizures," said Todd Wallach, President and Chief Executive Officer. "This is an exciting time for our company, as we enlarge our patent estate while also generating new scientific data confirming the validity and utility of our unique diagnostic approach, which has demonstrated the potential to accurately distinguish between actual seizures and seizure-like events. We will be presenting clinical data later this year showing that we can detect whether patients have had a recent seizure by analyzing the modulation of selected neuro-inflammatory biomarkers. Importantly, the presence of potentially confounding inflammatory disease had no impact on the diagnostic accuracy of our approach."

Epilepsy is difficult to diagnose. Only an estimated 20% of suspected seizure-like events are epilepsy-related. Distinguishing actual epileptic seizures from seizure-like events currently involves use of an electroencephalogram (EEG) along with comprehensive patient assessments by epileptologists. This gold standard for diagnosing the condition remains subjective, cumbersome, expensive and imprecise. Evogen is developing simple-to-administer blood tests that aim to diagnose epileptic seizures based on proprietary methods for identification and assessment of neuro-inflammatory biomarkers, leveraging recent research showing that neuro-inflammation is associated with epilepsy and is both a cause and consequence of seizures. Clinical studies have confirmed the ability of the company's neuro-inflammatory biomarkers to distinguish actual seizures from seizure-like events.

An accurate blood-based diagnostic test would enable epilepsy to be diagnosed and treated more rapidly and effectively and would also reduce the false positive diagnoses that can limit individuals' life choices, such as becoming ineligible for certain occupations or losing the right to drive. A blood-based diagnostic test also could be used to guide clinical research and help manage treatment over the lifecycle of the condition.

Wallach continued, "We are encouraged that both of our foundational patents licensed from the University of Pennsylvania were awarded fast track review by the USPTO, despite a challenging patent environment for biomarkers. We believe this reflects the potential importance of our approach. Based on our recent progress, we are initiating a financing to support the continued development and commercialization of neuro-inflammatory biomarkers, which we believe have the potential to transform the management of epilepsy, a common and disabling condition that currently lacks objective diagnostic tools."

About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide and more than 2 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. There are many different types of epilepsy, but the main characteristic of the condition is recurrent seizures. The accurate diagnosis of epilepsy remains a challenge, as current methods are subjective, cumbersome, expensive and imprecise.

About Evogen    
Evogen, Inc. is a leading developer of diagnostic, detection and sample collection solutions with successful products deployed worldwide. The company's Cognizance Biomarkers subsidiary is 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's patented EvoScoreDXTMbiomarker-based blood test has the potential to help revolutionize the diagnosis of epilepsy. In clinical studies, EvoScoreDX demonstrated sensitivity and specificity of 90% or more. The company is also developing EvoScoreGXTM comprehensive genomic testing for improved management of neurological disorders. For more information, visit evogen.com.



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