
Global regulatory bodies require testing of the pigs and xenograft recipients for porcine diseases that can infect humans.
These diseases are not critical to agriculture, so there are no available source for commercial testing for these agents.
Multiple screening points and sample sources are required, this creates a multi billion dollar market for disease screening services that do not exist today.
Global regulatory bodies require that pigs and the recipients of xenografts be screened for diseases that may be transmitted from pigs to humans.
Assays for agents of concern to regulatory authorities are not currently available commercially. Livestock producers are concerned mainly with diseases that affect production not those of concern to xenotransplantation.
This creates an opportunity for a testing service or testing kits for a long list of pathogenic agents. Given the testing applies to both the animals and recipients, from 10 to 20 samples will need to be tested per xenograft depending on the number of organs per animal that are used, supporting a multi-billion dollar opportunity.
Businesses include providing kits for the needed tests and/or performing tests on samples sent from pig production facilities and hospitals.
Each company developing pigs is currently doing their own pathogen screening programs, some with obvious problems. Regulatory bodies are certainly more comfortable with an independent expert. From a societal standpoint, a commercial service available to all would be more efficient.