SBIR/STTR Award attributes
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 there is no FDA-cleared, deployable, rapid MDR bacteria testing assay. Optowares proposes to develop a RAPID (Rapid lAbel-free Pathogen Identification and Detection) system, a portable, inexpensive and integrated system combining ATR-FTIR (Fourier Transformed Infrared spectroscopy with Attenuated Total Reflection), sample processing and machine learning. Optowares’ RAPID system can detect and quantify MDR bacteria directly from patient specimen in the field environment. 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 demonstrated feasibility of our label-free technology detecting and distinguishing 12 MDR/susceptible strains, with high sensitivity and specificity. Building upon this success, in Phase II we will build and optimize the system design to achieve 85% sensitivity and specificity in preclinical and clinical samples. We will deliver a functional prototype system to DHA and prepare the data package plan to be submitted for FDA approval at the end of Phase II.
