Roche Diagnostics' COBAS AmpliScreen HIV-1 and Hepatitis C (HCV) Tests to screen cadaveric organ and tissue donations have been approved by US FDA. The expanded claim for screening blood samples from these donors is in addition to testing whole blood, source plasma and potential living organ donors.
Tissues from cadaveric sources such as skin, bone, and ligaments are used in approximately 1 million medical procedures per year. These tissues can transmit the same viral infections as blood, and the products from a single tissue donation may be transplanted to an average of 50, or as many as 100 patients.
Heino von Prondzynski, CEO Division Roche Diagnostics and Member of the Executive Committee says, "The sensitivity and specificity of our tests as both a stand-alone and as used in conjunction with existing screening assays, enable tissue banks to further improve the safety of products used in a variety of therapeutic applications. Ultimately, we feel that transplant recipients will directly benefit from the agency's approval."
Roche Diagnostics' tests have the potential to help detect and thereby prevent transmission of HIV-1 and HCV, making the blood and tissue supply safer, sooner. In a recent documented case, a single antibody-negative donor in October 2000 donated 91 tissues and organs. Nucleic acid testing (NAT), as used in the COBAS AmpliScreen HIV-1 and HCV Tests, performed after donation and transplantation, found the donor to be HCV positive. Eight recipients were identified with HCV.
P. Robert Rigney, Jr., CEO, American Association of Tissue Banks said, "We are pleased that our tissue banks will have another screening test available that is specifically licensed for cadaveric specimens. These tests will help to ensure the safety of tissue allografts."