Verax Biomedical, Incorporated products

The Company’s first product is the Platelet PGD Test for the detection of bacterial contamination in platelets. It is the only rapid test cleared by the FDA as a Safety Measure for leukoreduced apheresis platelets in plasma, or platelet additive solution as well as prestorage pooled platelets within 24 hours prior to transfusion. Other tests for the detection of bacteria are typically applied early in platelet unit life or ride their results for several days and have been demonstrated to offer detection rates of just 15-40%.

Stem cells, activated leukocytes and other cellular therapies are another area of obvious applicability for PGD technology as these cells are grown in media that also support bacterial proliferation. As with platelets and red blood cells, current techniques for the detection of contaminating bacteria before transplantation are limited to existing microbiological techniques such as culture and Gram’s stain. Culture suffers the limitation of long time delay before results permitting the transplantation of contaminated cells before results are available and Gram’s stain is simply not sufficiently sensitive to reliably detect dangerous levels of bacteria.

Verax is currently developing a version of its PGD test to address the risk of bacterial contamination in red blood cells. While the risk of red blood cell contamination is lower than the risk of platelet contamination, at 1:20,000, it is the second largest infectious risk for the nation’s blood supply and far exceeds the risk associated with transfusion-transmitted viruses such as HIV, HCV, and WNV. Red blood cells are stored under refrigeration which limits the growth of many of the bacterial species that thrive in platelets. Some species, however, flourish in a refrigerated environment and are capable of reaching harmful levels during the significantly longer storage periods of red cells (up to 42 days vs. five days for platelets). Red blood cells tend to be contaminated with gram-negative bacteria such as Yersinia enterocolitica and Serratia Sp., which release endotoxin during storage and give rise to a greater rate of septicemia and fatal reactions.

We’re excited to introduce Platelet PGDprime, an easier way to test platelets. PGDprime preserves the performance of our proven Platelet PGD Test, while taking ease of use to a whole new level.