REGULATORY UPDATE: FDA Approves Second Malaria Test for Blood Donors

The Food and Drug Administration approved Grifols’ Procleix Plasmodium assay on Monday for use on the company’s Procleix Panther system. The approval represents the second FDA-licensed test to screen blood donors in the U.S. for malaria.

The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Plasmodium species (P. falciparum, P. knowlesi, P. malariae, P. ovale and P. vivax) in whole blood samples from individual human donors, including donors of blood and blood components. The test is also intended for use in testing samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. Whole blood donor samples are tested individually. The test is not intended for use to diagnose Plasmodium infection or for use on cord blood samples.

FDA’s Center for Biologics Evaluation and Research (CBER) published draft guidance last year proposing a selective testing approach to reduce the risk of transfusion-transmitted malaria (TTM) in blood and blood components, excluding source plasma.

AABB, America’s Blood Centers and the American Red Cross submitted joint comments on the draft guidance, reflecting priorities of the blood community, including considerations around maintaining current risk-reduction strategies and implementation of testing approaches. CBER plans to issue a final guidance this year.

Members with questions may contact regulatory@aabb.org.