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Babesia BPAC: FDA Perspective

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. FDA’s Current Proposal - I.

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Babesia BPAC: FDA Perspective

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  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. Questions to the Committee • 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? • 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. • Considering the current technologies, please comment on the suitability of antibody testing for Babesia infections in blood donors.

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