Rapid Test to Detect Bacteria in Platelet Concentrates

DESCRIPTION (provided by applicant): Verax Biomedical Inc. proposes to develop a rapid, accurate, cost-effective screening test to detect a broad array of bacterial contaminants in stored human platelet concentrates for use near the time of transfusion. The risk of bacterial contamination is approximately 1 in 2000 transfusions, which makes it the single greatest infectious risk in transfusion medicine today. Currently, no rapid, broadly reacting detection test is available commercially. Verax has assembled a set of binding agents that selectively bind to conserved cell- surface structures of either Gram positive or Gram negative bacteria and is the basis of Verax's proprietary Pan Genera Detection technology (PGD). In Phase I, Verax demonstrated the feasibility of the PGD technology in detection of bacterially contaminated platelets by formatting these binding agents in an easy- to-use immunoassay rapid test. In Phase II, Verax commercially developed and optimized the rapid test, demonstrated reliable manufacture of the test and verified assay performance in a pre-clinical setting. For Phase II Continuation, Verax will demonstrate scale-up manufacturing, validate manufacturing processes and validate clinical performance. The clinical validation studies will include tests for the following performance characteristics: clinical specificity, pan genera reactivity, analytical sensitivity, reproducibility of detection, interfering substances, user robustness and product stability. In addition, Verax will perform the first-ever U.S. incidence study for bacterial contamination in platelets by screening a large population of stored (day 2-5 post-collection) human platelets (leukoreduced and non-leukoreduced) near the time of transfusion with the PGD Test and plate culture (aerobic and anaerobic). The outcome of that study will be a clear definition of the incidence of bacterial contamination in platelets near the time of transfusion, the bacterial species implicated in the contamination events, and the titer of bacteria at the time of testing. At the end of this project, Verax will submit the Platelet PGD Test for BLA approval to the FDA.