Innovative PoCT for Rapid Differential Diagnosis of Stroke

Thrombolytic treatment has proven and substantial benefit for patients with acute cerebral ischemia; however, this treatment must be administered within 3-4.5 hours to be effective. Much attention has therefore focused on identifying biomarkers for a Point-of-Care Testing (PoCT) platform for rapid and objective diagnosis of this condition.

To address this critical need, we utilized a biomimicry-based approach to produce a novel biosensor for biomarkers of brain injuries. Tethered Enzyme Technology (TET^TM) harnesses the catalytic efficiency of enzymes functionally immobilized onto nanoparticles as a novel biosensor platform that enables rapid, low-cost, and easy-to-use PoCT.

We have established the use of TET to rapidly detect the biomarker neuron-specific enolase (NSE), one of the most thoroughly studied brain injury biomarkers, in both an animal model of stroke and in blood samples from human subjects (Cohen et al. PLoS ONE, 2015). In related studies, we have demonstrated the advantages of using TET to quantify NSE’s enzymatic activity in bio-fluids when compared to gold-standard detection methods (Cohen et al. Current Biomarker Findings, 2017).

Importantly, through a pre-clinical study performed at the Stroke Center at Robert Packer Hospital (Sayre, PA, USA), we show that detecting circulating NSE levels with the TET based technology can significantly shorten the process of differentiating stroke patients from those that are presenting stroke-like symptoms due to “stroke-mimic” conditions.

Together, these data provide a compelling proof-of-concept for the use of TET as a platform for rapid biomarker detection, and the potential to fulfill the unmet need in acute stroke management.