Rugged, Hand-held, and Array-based Traumatic Brain Injury Biomarker Biosensor

Traumatic brain injury (TBI) accounted for 15 - 25 % of all combat casualties since WW-II. In the US, 1.4 million people annually sustain a TBI causing 50,000 deaths. Lynntech proposes to develop a hand-held, automated, rugged, field-deployable diagnostic sensor for use by deployed medical personnel for assessing the extent of a traumatic head injury in a wounded soldier. The diagnostic system utilizes small, disposable cartridges for analyzing a panel of clinically validated traumatic brain injury biomarkers in biological samples. In Phase I, Lynntech demonstrated specific concentration dependent response of a model biomarker system with detection limits from 50 pg/mL to 100 micrograms/mL in 10 minutes or less in a bench scale prototype detection system. In Phase II, Lynntech will assemble and deliver a prototype detection system incorporating a panel of traumatic brain injury biomarker recognition elements. Lynntech in collaboration with experts in traumatic brain injury biomarkers will validate the detection system with clinical biological samples in accordance with the FDA 510(k) application submission requirements to facilitate the transition of the technology to the Phase III commercial partner. Lynntech has identified and established a relationship with a potential Phase III partner for manufacturing and distribution of the proposed diagnostic system.