REGULATORY UPDATE: BPAC Briefing Document Describes Strategies for Malaria Testing of Blood Donors

March 27, 2024

The Food and Drug Administration’s Blood Products Advisory Committee (BPAC) released a briefing document ahead of its May 9 meeting that outlines proposed strategies to reduce the risk of transfusion-transmitted malaria through testing of blood donations.

FDA approved the Cobas malaria test (Roche) for use on the Cobas 6800/8800 Systems on March 19. The approval marks the first FDA-licensed test to screen blood donors in the U.S. for malaria.

Following this approval, FDA is seeking feedback on the proposed selective nucleic acid testing (NAT) strategies. These strategies will consider several risk factors, including a history of malaria, prior residence in malaria-endemic countries, recent travel to malaria-endemic areas and local mosquito-borne malaria transmission in a geographic area of the U.S. FDA expects these testing strategies to reduce the number of unnecessary deferrals of healthy individuals based on the current strategy of screening questions alone.

FDA will ask the committee to comment on the proposed strategies to:

  • Selectively test blood donations from donors at risk for malaria.
  • Implement time-limited NAT screening of all donations in a geographic collection area when a single case of local mosquito-borne malaria is reported by public health officials.  

AABB will submit a statement to the BPAC on FDA’s proposed donor screening strategies. AABB invites members to share their feedback with AABB Regulatory Affairs via email