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Evogen Moves Into Molecular Diagnostics With Initial Focus on Epilepsy

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NEW YORK (GenomeWeb) – Biotech firm Evogen is moving from its traditional focus on infectious disease threat detection to precision medicine and molecular diagnostics, with a primary emphasis on neurology.

The company's first product in this area is the EvoScore START test, a blood-based proteomic assay intended to help doctors distinguish epileptic seizures from seizures with other causes. According to Todd Wallach, Evogen's president and CEO, the company plans to launch the diagnostic in targeted markets as a laboratory-developed test in 2017.

Evogen also announced this week that it is collaborating with drugmaker UCB, a leading developer of anti-epileptic therapies, on the development of the EvoScore test. Wallach declined to provide details regarding specific goals of the collaboration but noted that it would give Evogen access toUCB's epilepsy resources, including patient databases, clinical trial data, and networks of thought leaders in the field.

According to Wallach, only around 15 percent of seizure-like events are actually epileptic seizures, and identifying which seizures are due to epilepsy can be challenging, often requiring months of follow up.

This, he noted, can delay patients starting effective treatment for the condition. The inconclusive nature of many diagnoses can also lead to patients without the condition receiving anti-epileptic drugs, many of which havesignificant side effects, he said.

"You wind up with both over-treatment and under-treatment," he said. Additionally, patients' quality of life can be significantly impacted during the time it takes to make a diagnosis.

"For instance, if someone has a suspected epileptic seizure, they lose their license, they can't drive," Wallach said, and patients frequently mentioned during interviews that they would like to get a diagnosis quickly.

"So the ability for this test to, first, confidently identify the seizure, and, second, get the person on the appropriate treatment is where we see it going," he said. "If they had [an epileptic] seizure, we can get them on therapy more quickly. If they're negative, we can move them to other specialties, for example, cardiology or infectious disease."

The assay looks for three protein markers, tumor necrosis factor alpha (TNFα), thymus and activation regulated chemokine (TARC), and soluble intercellular adhesion molecule 5 (sICAM5). The markers were originally identified 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, assistant director of the Penn Epilepsy Center. The two formed a company, Cognizance Biomarkers, to commercialize the markers, which Evogen acquired last year.

In a study presented this week at the America Epilepsy Society annual meeting, researchers including Pollard and Crino investigated the test's ability to distinguish between epilepsy patients and healthy controls. Looking at plasma samples from 28 patients with epilepsy who had experienced an event within 24 hours and plasma samples from 29 healthy controls, they found that the test could distinguish between the two populations with sensitivity ranging from 89.3 percent to 93.9 percent and specificity between 75.9 percent and 83.3 percent.

The data presented at the AES meeting derived from only a small sample size and looked at epilepsy patients versus healthy controls, as opposed to controls with seizure-like conditions that might be mistaken for epilepsy. Wallach said that it represented a subset of the data the company has generated on the test's performance to date and that in addition to this cohort, it has looked at other groups of patients, including those with conditions mimicking epilepsy. He said that the company planned to release data covering the test's performance in such populations in the future.

Researchers from Evogen and it collaborators also presented data at the AES meeting looking at the effectiveness of electroencephalograms (EEGs) for diagnosing epilepsy. EEGs are the current gold standard for diagnosing the condition, Wallach said, but they have a high false negative rate, detecting only about a third of cases. The study presented this week bore this out, finding in an analysis of 240 patients seen at the Penn Epilepsy Center that EEGs "provided some diagnostic value" for up to 32 percent of patients. The study noted that larger prospective studies of EEG effectiveness have found the tool useful in 33.6 percent of cases.

Evogen is launching the EvoScore test as an LDT, but the company will consider taking it through the US Food and Drug Administration if necessary, Wallach said.

"We envision the test as an LDT, and based upon our market feedback, a turnaround of 24 to 72 hours is sufficient for clinicians to respond," he said. "If we find that we need to get closer to the patients, that's when we'll look at [FDA clearance] — if we need to bring this into the clinic, into the ER, or into a doctor's office directly."

Wallach said Evogen also plans to develop its markers for use in guiding patient treatment and monitoring the status of patients' conditions.

"Moving forward, we will look at personalized medicine approaches, look at patient history over time and how these biomarkers help predict, for instance, [whether patients] are on the right drugs," he said. "Are you going to be seizing more often than not? Do you need increased epilepsy care?"

In addition to its proteomics work, Evogen is exploring genomic markers for neurological conditions that Wallach described as being "classically underserved," though he declined to elaborate.

Prior to acquiring Cognizance, Evogen's business centered primarily around biothreat detection, for which it offers its SpinCon platform for capturing airborne bioaerosols, vapors, and particulates, including pathogens, as well as its HyBeacon reagents, which are PCR probes for pathogen detection.

According to Wallach, the Overland Park, Kansas-based company, which has 10 employees, is profitable and is funding its move towards molecular diagnostics organically.

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