Nanowire Array Diagnostics for Early Multiorgan Injury in Saliva

DoD requires a single multiplexed salivary diagnostic bioassay to indicate early multiorgan injury to determine systemic toxicity. This assay should detect clinically validated biomarkers quantitatively in saliva to indicate organ injury due to chemical/xenobiotic exposure. Innosense LLC (ISL) will innovate on its proprietary polymer nanowire platform to fabricate Nano-Mos, which will detect salivary biomarkers in a single assay within 30 minutes with =95 % specificity. Although saliva as a biofluid sample is considered the holy grail of diagnostics, its clinical utility was somewhat unsubstantiated for systemic diseases until recently when salivary genome, transcriptome, proteome results have exponentially increased our knowledge. Ultrasensitive nanowire-based devices have the analytical capability to detect biomarkers in the femtomolar range, hence ideal for detecting target molecules which are often present in low concentration in saliva than conventional testing matrices, such as serum. In Phase I, ISL will construct the working model of Nano-Mos and evaluate it. In Phase II, ISL will collaborate with Oasis Diagnostics to construct a prototype with accompanying hardware and software, and start laying out the plan for the FDA approval process.