The United States of America, As Represented by the Secretary, Department of Health and Human Services

Shanmugam Vedapuri

Walid M Heneine

William M Switzer

Compositions, methods and diagnostic devices for monitoring graft integrity in xenotransplantation and for detecting infectious agents transmitted by the xenograft are described. In particular, the compositions, methods and devices are useful for determining porcine xenograft integrity and persistence and can detect the presence of PERV (porcine endogenous retrovirus) in a biological sample. The compositions, methods and devices are useful for determining or monitoring graft survival and rejection in recipients of xenografts and are useful for detecting the presence of pig cell and PERV infection in a xenotransplant recipient or donor. In addition, the compositions, methods and devices are useful for screening therapeutic products to be administered to humans to ensure that the products are free of pig cells, and thus free of PERV contamination, prior to administration.

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Duluth, GA, United States of America

Shanmugam Vedapuri