US military service members experiencing combated-related wounds have high chances of developing infection by multidrug resistant (MDR) bacteria. MDR infection results in higher amputation rate, subsequent operations and extended recovery time. Currently theres no FDA-cleared, deployable, rapid MDR bacteria testing assay. Optowares proposes to develop a portable, inexpensive lab-on-a-chip system, in combination with machine learning, for MDR bacteria detection and quantification directly from patient specimen. The proposed system is based on transmission Fourier transform infrared spectroscopy (FTIR) with attenuated total reflection (ATR). The proposed system leverages off Optowares expertise in ruggedizing laboratory-grade instruments for use in the field by the military, and past experience in ultra-sensitive and specific micro-organism detection in complex mixtures. In Phase I we will demonstrate the feasibility of laboratory prototype of the proposed system in identification and quantification of six MDR and six susceptible strains, with the goal to achieve 85% sensitivity and specificity. Guided by the Phase I results, we will finalize the system design, strategize for scale-up production, and deliver 3 initial lots of 250 prototypes for evaluation by Defense Health Agency while preparing for the data package to be submitted for FDA-approval at the end of Phase II.
