Re: Docket No. FDA- 2009-D-0137
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the draft guidance Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma Cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).
BIO represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
This is a well written document that provides useful information for regulated industry. Finalization of the guidance will be welcome and important because there is a great potential impact of communicable diseases, such as T. cruzi, on a product that is scaled up through manufacturing and may be distributed to millions of recipients (e.g., an allogeneic cell based product).
We note that although it is possible to determine the existence of serum antibodies suggesting chronic infection, donors who have acute infection with T. cruzi may not be identified by the test. Therefore (as we also note in our specific comments below), it is important to mitigate risk by taking a relevant medical history as well as screening peripheral blood smears for the presence of trypomastigotes, blood cultures for T. cruzi, and blood for the presence of DNA by PCR, or by requiring re-testing of live donors for serum antibodies after a specified period of time (e.g., 1 month).