Fast-track phage-amplified maldi-TOF MS for rapid phenotypic UTI diagnosis and antimicrobial susceptibility testing - cobio NIH sbir fast-track project summary/abstract urinary tract infections (UTIS)…

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Cobio Diagnostics Inc. $306,867 on August 21, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to continue feasibility testing of a phage-based diagnostic technology for rapid urinary tract infection diagnosis and antimicrobial susceptibility testing.

Cobio will develop and validate a MALDI-TOF mass spectrometry platform that delivers bacterial identification, antibiotic susceptibility testing, and minimum inhibitory concentration results directly from urine specimens within 2.5 hours without requiring bacterial culture. The technology aims to eliminate the 1–3 day turnaround of current culture-reliant methods, reducing empiric broad-spectrum antimicrobial use while improving treatment precision for the 10.5 million UTIs diagnosed annually in the United States.

Performance occurs in Aurora, Colorado, with a period of performance through April 30, 2029. This is a Small Business Innovation Research Fast-Track Project Grant, an assistance type that accelerates development of small-business innovations with commercial potential. The award supports Phase II feasibility testing following earlier phase work on phage-amplified rapid diagnostics for UTI diagnosis.

Fast-track phage-amplified maldi-TOF MS for rapid phenotypic UTI diagnosis and antimicrobial susceptibility testing - cobio NIH sbir fast-track project summary/abstract urinary tract infections (UTIS) are the most common infection in the U.S., with 10.5 million diagnosed and treated per year at a cost of $3 billion. The number of antimicrobial-resistant UTIS is increasing at an alarming rate, and determining which drugs are still effective becomes more difficult. Current clinical approaches rely increasingly on culture-reliant maldi-TOF mass spectrometry for bacterial ID, which requires 1-3 days (or longer) and lacks a capability for antibiotic susceptibility testing (AST). This forces hospital physicians to treat with broad-spectrum antimicrobial drugs while awaiting test results. Cobio diagnostics proposes to continue feasibility testing of our phage-based technology that provides maldi ID, AST, and minimum inhibitory concentration (MIC) direct-from-specimen results within 2.5 hours without the need to culture bacterial colonies. Successful development, validation and commercialization of this next-generation, rapid diagnostic will greatly reduce testing times and healthcare costs while improving treatment outcomes and conserve drug effectiveness to benefit future patients. The severity of UTIS-80% of which are caused by E. Coli-range from asymptomatic bacteriuria to pyelonephritis, which can result in complications including kidney failure and septicemia with significant long- term effects or death. One in 3 UTIS are sulfamethoxazole/trimethoprim-resistant (once the standard treatment). One in five are resistant to five or more drugs, with a smaller number now resistant to all available drugs. Current UTI diagnostic approaches require time-consuming pre-analysis organism isolation and enrichment and do not provide comprehensive AST/MIC data. The ability to rapidly ID and assess drug resistance is critical to addressing the emergence of multi-drug-resistant (MDR) UTIS in hospital settings. Therefore, the overall goal of this multi-phase sbir fast-track project is to leverage our strong preliminary data to develop, demonstrate effectiveness, validate, and commercialize phaast-maldi, cobio diagnostics' proprietary phage-amplified maldi-TOF MS assay, which is a rapid, multiplexed, phenotypic test for bacterial ID/AST/MIC directly in urine-and ultimately to gain FDA clearance for clinical UTI diagnostic routine. Cobio's R & D staff will team experts at the university of colorado and children's hospital colorado in phase I to develop phaast-maldi methods and prototype analysis/reporting software, demonstrate the effectiveness of phaast-maldi ID/AST/MIC in urine, and validate direct-from-urine analysis of UTI patient specimens and isolates with comparison to standard-of-care diagnostic practices. This will establish the potential of our novel approach within the limited scope of a phase I feasibility project and will set the stage for larger phase II demonstration against other MDR UTI pathogens such as klebsiella pneumoniae and enterococcus faecalis.