America’s Blood Centers (ABC) has submitted malaria testing recommendations in comments to the U.S. Food and Drug Administration’s (FDA) Blood Products Advisory Committee (BPAC). The malaria testing recommendations are in response to proposed strategies to reduce the risk of transfusion-transmitted malaria (TTM). The ABC comments “strongly recommended” that the agency delay publishing draft guidance until modeling studies are finished and additional malaria testing assays are approved and available. “Prior to publication of a draft guidance on malaria testing, real world modeling studies should be performed to determine the sensitivity of available tests, including studies performed in malaria-endemic locations and including data on semi-immune donor populations.” The comments specified that, “there is currently only one malaria test approved for screening of the blood supply. As FDA knows, this raises concerns about the blood supply’s reliance on a single test. Without an alternative, supply chain challenges could cripple the blood supply.”
Additional malaria testing recommendations and acknowledgments from ABC also included:
- “ABC applauds FDA for recognizing universal testing of all donations is not a cost-effective strategy for blood safety in the U.S.;
- ABC strongly recommends that FDA maintain the current deferrals as an option:
- while also allowing for a selective testing strategy for individuals with a history of malaria who were not prior residents of a malaria-endemic country;
- while also allowing for a selective testing strategy for prior residents of malaria-endemic countries;
- ABC supports an option for selective testing for residents of nonendemic countries who have traveled to malaria-endemic areas in the past three months;
- ABC supports a testing strategy for donations in regions of the U.S. with local, mosquito- borne malaria transmission, but recommends having a higher minimum threshold for triggering testing; [and]
- ABC applauds the FDA for allowing the use of an FDA-approved pathogen reduction technology device in lieu of using the screening questions for malaria risk followed by nucleic acid testing (NAT) for malaria.”
The BPAC is set to meet on May 9th. ABC has formally requested that ABC Chief Medical Officer Jed Gorlin, MD, MBA be able to comment during the meeting explain ABC’s malaria testing recommendations, “in support of the safety of the current deferral strategy and express the need to ensure that any changes to that strategy are evidenced-based, cost effective, and operationally feasible.”
Meeting materials are available ahead of the meeting and include a briefing document and meeting discussion questions. The committee is specifically being asked to comment on agency’s proposed malaria testing recommendations including:
- “FDA’s proposed strategies for selectively testing blood donations from donors at risk for malaria using an FDA-licensed nucleic acid test (NAT); [and]
- FDA’s proposal that blood establishments should implement time limited NAT screening of all donations collected in area(s) of the U.S. when a single case of local mosquito-borne malaria is reported by public health authorities.”
An archive of ABC comments and letters is available on the ABC website.