Verax Biomedical Inc. proposes to develop a rapid, accurate, cost-effective screening test to detect a broad array of bacterial contaminants in stored human platelets. The risk of bacterial contamination is approximately 1 per 2,000 donations, which makes it the single greatest infectious risk in transfusion medicine today. Currently, no inexpensive or rapid broad detection test is available commercially. Verax has assembled a panel of antibodies and other binding agents that selectively bind conserved structures on the surface of either Gram-positive or Gram-negative bacteria. These reagents demonstrate cross-genera and cross-species binding affinities for bacteria that are known to infect human platelets and are readily adaptable for use in immunoassays. In this Phase I project, Verax will verify the feasibility of a rapid, sensitive immunoassay in a format that is practical for routine platelet screening in hospital transfusion services and blood centers. This will lead to a Phase II proposal to commercially develop and validate the assay for regulatory submission. The successful development of Verax's Bacterial Class Detection technology will help improve the availability and safety of the human blood supply, and will have broad potential applications for bacterial detection for patient diagnostic use, food testing, environmental testing and research applications.
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