Cell Therapy PGD Test

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.

In late 2003, Verax was approached by researchers at the National Institutes of Health (NIH) with the request that we investigate the applicability of PGD technology to cellular therapies as a rapid QC test for bacterial contamination. In response, Verax scientists developed a prototype sample processing technique and successfully demonstrated the feasibility of detecting bacteria in a wide variety of the most commonly used cell expansion media using a PGD test device. These data were presented at the 2004 annual meeting of the International Society for Cellular Therapies in Dublin, Ireland. The data were also published in the journal Transfusion (Vol. 44, No.9S) and presented at the 2004 annual meeting of the American Association of Blood Banks.

The Company intends to pursue development in this field as the area of cellular therapies continues to emerge. Currently, over 100 companies are developing a variety of cell based therapies and stem cell transplants are increasing at a rate of 23% per year.