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 preparations. 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 identified a panel of antibodies, which selectively bind to conserved structures on the surface of Gram-positive or Gram-negative bacteria. These binding agents demonstrate cross-genera and cross-species binding affinities for the bacteria that are known to contaminate human platelet units for transfusion. These antibodies have been incorporated into both ELISA and lateral-flow assays to detect a broad array of bacteria with high levels of sensitivity and specificity. In this Phase II project, Verax will commercially develop and validate the lateral-flow assay for regulatory submission. The successful development of Verax's Bacterial Class Detection technology will improve the availability and safety of the human blood supply and will have broad potential for bacterial detection applications in human diagnostic, food testing, environmental testing and other research uses.
