SBIR-STTR Award

Battlefield Deployable Lab-on-a-chip for Rapid MDR Bacteria Detection and Quantification in Infected Combat-related Wounds
Award last edited on: 5/28/2023

Sponsored Program
SBIR
Awarding Agency
DOD : DHA
Total Award Amount
$1,349,740
Award Phase
2
Solicitation Topic Code
DHA201-001
Principal Investigator
Melissa (Ying) Chen

Company Information

Optowares Incorporated

15 Presidential Way
Woburn, MA 01801
   (781) 465-2623
   info@optowares.com
   www.optowares.com
Location: Single
Congr. District: 05
County: Middlesex

Phase I

Contract Number: W81XWH20P0146
Start Date: 9/30/2020    Completed: 3/29/2021
Phase I year
2020
Phase I Amount
$249,789
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’s 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.

Phase II

Contract Number: W81XWH-21-C-0078
Start Date: 9/15/2021    Completed: 1/14/2024
Phase II year
2021
Phase II Amount
$1,099,951
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.