Signal-amplified, Real-time Therapeutic Drug Monitoring Device

Maximizing the effectiveness whilst simultaneously minimizing the toxicity of antimicrobial agents is the most important step in any effective infectious disease treatment regimen, however, escalating resistance, lack of novel antibiotics and complexity in patient populations has rendered many traditional dosing regimens ineffective. To compound the issue, some antimicrobials, such as aminoglycosides, possess narrow therapeutic indices, and toxicity may be severe and irreversible. One method to improve antimicrobial dosing in patients is through application of therapeutic drug monitoring (TDM). In Phase I, Lynntech obtained strong proof of concept for a novel microfluidic, real-time, point-of-care, therapeutic monitor capable of detecting antimicrobial concentrations in human blood within clinically relevant ranges. In the proposed Phase II, the biosensor will be optimized for clinical accuracy, reproducibility, stability and shelf-life. A compact, stand-alone device will be prototyped and evaluated, in vivo, in small animal model studies as well as a limited non-interventional human pre-clinical trial in collaboration with the University of Houston. In addition, we will develop the platform technology for the detection of additional antimicrobial targets of interest. Successful completion of the Phase II will enable the follow-on Phase III to focus on multicenter human clinical trials, if necessary, FDA clearance and commercial deployment.