1 Babesia BPAC: FDA Perspective Sanjai Kumar, PhD Division of Emerging and Transfusion- Transmitted Diseases Office of Blood Research and Review CBER, FDA Blood Products Advisory Committee Meeting July 26, 2010

2 FDA’s Current Proposal - I FDA is proposing a broad-based, region-specific approach to blood donor testing for Babesia infection rather than a national testing program. The FDA risk analysis suggests that implementation of a donor screening test in 20 States and the District of Columbia would address an estimated 93% of the current risk in donors.

3 FDA’s Current Proposal - II Under this strategy, the following states are proposed to undergo testing: New York, Connecticut, Massachusetts, California, New Jersey, Maryland, Virginia, Florida, Pennsylvania, Rhode Island, Texas, Michigan, Minnesota, Wisconsin, New Hampshire, Maine, Ohio, Indiana, Delaware, and Vermont, and the District of Columbia. The proposed 20 Babesia risk states and the District of Columbia represent approximately 60% of the total U.S. population ages 18 years and older.

4 The 20 Babesia Risk States and the District of Columbia Proposed for Donor Testing

5 FDA’s Current Proposal – III Assuming that blood donation rates are approximately equal across states, approximately 60% of U.S. blood supply would undergo testing for Babesia. Given the current status of Babesia detection tests, we are proposing a two- phase testing strategy:

6 FDA’s Current Proposal – IV Phase I: Donor testing in the proposed 20 states and the District of Columbia by NAT. However, if an investigational antibody-based test for donor screening is available, then both NAT and/or antibody testing may be applied. Phase II: Testing might be extended to include donors in lower-risk areas or in areas where natural transmission of Babesia is not known but clinical cases and/or infected blood donors have been reported. High-throughput antibody-based tests may be more applicable for donor screening in phase-II testing.

7 1.Do the FDA risk analysis and the available CMS and CDC datasets together support the concept of regional testing of blood donors for Babesia infections? 2.Given the current sensitivity limitation of NAT for Babesia, please comment on whether the public health benefits of NAT testing warrant consideration of broad-based regional testing of donors by NAT. 3.Considering the current technologies, please comment on the suitability of antibody testing for Babesia infections in blood donors. Questions to the Committee