SILVER LAKE RESEARCH CORPORATION — Department of Health and Human Services STTR Phase II: NIAID

Description

PROJECT SUMMARY ABSTRACT This proposal describes Phase II of the development of a rapid immunoassay test kit for the determination oflactam antibiotic resistanceto be used as a point of care diagnostic test for urinary tract infectionsTodayantibiotics for UTI are prescribed empiricallywith no diagnostics available to clinicians to avoid treating resistant infections with the very drug to which the pathogens are resistantThis problem has resulted in ever increasing prevalence of resistancerendering many drugs unusableThe proposed test kit will be a lateral flow immunoassaysimilar in principle to a home pregnancy testThe test design is based on monoclonal antibodies specific forlactamasesthe enzymes conferring resistance tolactam antibioticsIn Phase Ithe applicant developed a working assay capable of distinguishinglactam resistant bacteria fromlactam sensitive isolatesIn Phase IIthis assay will be converted into a simpleminute test kitand a complete manufacturable product will be developedClinical validation studies will be carried out to determine the real world performance of the productAt the successful conclusion of Phase IIwe expect to demonstrate a rapidsimpleand accurate test forlactam resistance in UTIenabling clinicians to test unprocessed urine samples and determine the optimal antibiotics based on the resultsThis capability promises to revolutionize the management of bacterial UTIsgiving clinicians the ability to selectively prescribe olderlactam antibiotics to test neagtive patients with a high confidence of efficacySuch treatment is expected to improve outcomes for patients while dramatically reducing the empiric use of broad spectrum antibiotics