For the first time, instant and accurate blood level monitoring is possible for schizophrenia treatment, thanks to a sensor developed by Ben-Gurion University of the Negev (BGU) researchers.
Clozapine is considered the most effective antipsychotic medication for schizophrenia and the only antipsychotic currently approved for treatment-resistant schizophrenia (TRS) which afflicts approximately one-third of the three million US schizophrenic patients.
Monitoring clozapine blood levels is important and, prior to this breakthrough invention, often challenging. It involves frequent, invasive blood draws at a medical office with long test prep time, so it is difficult to accurately measure the correct dose for maximum therapeutic benefit and fewer side effects. Blood concentration levels can differ up to 20-fold between individuals prescribed identical doses, and can be greatly affected by age, gender, drug interactions and other parameters.
As a result, clozapine is still one of the most underutilized evidence-based treatments in the field of mental health.
The technology, developed by Dr Hadar Ben-Yoav, of theBGU Department of Biomedical Engineering and Ilse Katz Institute for Nanoscale Science and Technology,is essentially a miniaturised microelectrode sensor that will immediately detect clozapine levels in a microliter-sample of blood obtained by a simple finger prick.
The sensor can be used as a platform for detecting other redox (reducing-oxidizing) chemicals in small quantities of untreated, whole blood samples thus paving the way for developing miniaturised, point-of-care devices for monitoring.
A recent study conducted in collaboration with the School of Medicine at the University of Maryland showed reliable results in clozapine blood concentrations measured by the device compared to standard laboratory blood tests in schizophrenia patients.
According to Dr Ben-Yoav: ‘We were excited to see the promising initial results of our new device, that can supply instantaneous, accurate results of blood clozapine levels to people with schizophrenia and their caretakers. Our device can be the basis of rapid, point-of-care patient monitoring that will provide personalized medicine through close monitoring and dose adjustment of this important drug.’
‘We hope that this innovative invention will help increase patient compliance and facilitate the use of clozapine for people living with schizophrenia,’ said Josh Peleg, chief executive officer of BGN Technologies. ‘The medical research field is investing considerable effort in simplifying and miniaturising various blood tests, enabling patients to receive medical results immediately and at home and the device is an important contribution to this trend. Having filed for patent protection, BGN Technologies is currently seeking a strategic partner to further develop and commercialise this device.’