Diagnostic Device for Detecting Biomarkers of Early Multiorgan Injury in Saliva

DoD requires a single, multiplexed, saliva-based diagnostic bioassay to determine multiorgan injury-relevant systemic toxicity. This assay should quantitatively-detect clinically relevant biomarkers in saliva and validate organ injury arising from chemical/xenobiotic exposure. Innosense LLC (ISL) is building on its proprietary carbon nanotube platform to construct Nano-Mos for detecting salivary biomarkers with =95 % specificity. Saliva as a non-invasively-acquired patient sample is considered the "Holy Grail" of molecular diagnostics. Its clinical utility, however, was somewhat unsubstantiated for systemic diseases until recently when salivary genome, transcriptome, proteome results have exponentially increased our knowledge. In Phase I, ISL detected cortisol as a biomarker in saliva samples in the femtomolar range within 15 minutes for indicating overall stress levels in human. In Phase II, ISL will optimize the fabrication steps with scale-up in focus, build a prototype and perform rigorous testing with saliva samples of diverse origin. ISL will formalize FDA approval steps toward market entry. Nano-Mos is ideal for detecting target molecules that are often present in low concentration in saliva compared to serum. This unique feature of Nano-Mos, coupled with uncomplicated sample processing for saliva, establishes its versatility as a fieldable diagnostic device for military personnel and first responders.