BioEP - a new digital biomarker of epilepsy
A digital biomarker of seizure risk that works on background (e.g. seizure free) EEG. Neuronostics are currently developing a clinical decision support system that will bring the power of BioEP to healthcare providers globally.
What is BioEP and how can it help?
BioEP is a new digital biomarker of epilepsy that uses routinely collected EEG recordings gathered as part of the patient’s diagnostic journey, and automatically utilises EEG features which, for the large part, are not visible to the naked eye. BioEP produces a mathematical model of the cortical network structure. Simulations of this model are run to observe how likely it is for the person’s brain to produce epileptiform activity. This helps to inform the likelihood that a person will have an epileptic seizure and therefore, acts as an additional piece of evidence to support diagnostic and prognostic decisions of epilepsy. Studies in over 700 people have demonstrated that BioEP can improve accuracy of diagnosis.
How BioEP works
A clinician uploads an EEG. The BioEP score is calculated and a report is made available to the clinic. The report is used alongside other clinical information to support clinical decision making.
How long BioEP takes
BioEP takes just 20 minutes to calculate from 5 minutes of EEG. The average clinical diagnosis takes over a year. BioEP has the potential to radically improve the speed to diagnosis
We have CE-marked BioEP v1.0 as a Class I medical device.
Epilepsy is hard to diagnose and difficult to treat
In current clinical practice, EEGs are used to search for the presence of abnormalities indicative of epilepsy (typically interictal spikes or discharges). These electrographic patterns, alongside behavioural manifestations, serve as the main diagnostic marker for epilepsy and signify an increased tendency for the brain to generate seizures. However, 70% of EEGs contain no such features and are considered clinically negative.
Because the majority of EEGs do not capture any epileptiform activity, multiple EEG tests are often required. This reduces service capacity in neurophysiology and neurology centres, is inconvenient for the individual undergoing diagnosis and results in delays and uncertainty. It takes on average longer than a year to diagnose epilepsy. Delays in diagnosis cause major impacts on quality and length of life.
There are no robust clinical markers of prognosis. Doctors rely on patient self-reports. Information gathered by patients about their condition is often missing or fallible. There is at present neither the capacity nor a marker to monitor treatment progress strategically. As a result, fewer than 50% of people are seizure free after one year on medication. Management is effectively trial and error, with doctors relying on patients to report their response to treatment. We are looking to change that.
How BioEP can improve clinical care pathways
Benefits at a glance
- Supports diagnosis from first EEG
- Informs optimal care pathway
- Indicates response to treatment
Supports diagnosis from first EEG
We don’t need to wait to observe epileptiform activity. We can use apparently normal, background EEG to identify the likelihood of future seizures. This means we can support a diagnosis from the first EEG that BioEP is run on. Using BioEP can therefore reduce diagnostic delay and improve quality of life for patients.
Currently in research
Informs optimal care pathway
BioEP can expedite a diagnosis of epilepsy or in some cases, a differential diagnosis such as dissociative seizures. In doing so, patients can be transferred to the next step of the care pathway more quickly. If BioEP predicts a high likelihood of a person having a seizure, doctors can refer with urgency for more tests or even have more certainty around prescribing medication. If BioEP indicates a likelihood of a person having dissociative seizures, that person could be referred to the care of neuropsychiatry earlier in the care pathway. Being able to expedite patients through the pathway towards treatment reduces the numbers of patients presenting in A&E with seizures and results in better quality of life for patients.
Indicates response to treatment
Once medication is started, BioEP can be performed regularly to capture the effect of treatment response. This objective approach reduces the uncertainty about whether medication is working and may speed up the trial-and-error process of identifying the optimal medication for a person with epilepsy. This could have a radical impact for people with epilepsy and the healthcare system improving lives and reducing costs.
BioEP regulatory compliance
BioEP is a Class 1 Medical Device under 93/42/EEC Medical Device Directive (MDD) and is both UKCA & CE marked. Neuronostics are Cyber Essentials certified and registered with ISO for data protection
Our research
BioEP is the culmination of over a decade of pioneering research exploring the role of dynamic brain network analysis in the diagnosis of neurological conditions. It represents a key milestone on the way to bringing neurology up to speed with other indications, such as cardiology, in creating a more proactive model of care.
