FDA guidance on cell/tissue donor screening test:
This article was originally published in Clinica
The FDA has issued a guidance on how manufacturers, which currently sell test kits to screen for the presence of disease in a cadaveric blood specimen, can expand the indication so the test can be used to screen for disease in donors of human cells, tissues and cellular and tissue-based products. Such a screening test is now necessary in the wake of a recent final rule requiring that donors of cells and tissue be tested for the presence of certain communicable diseases. Currently, only one company - Genetic Systems, a subsidiary of Sanofi Diagnostics Pasteur - markets a test kit for cadaveric blood specimens.