REGULATORY UPDATE: FDA Approves First Malaria Test for Blood Donors

The Food and Drug Administration approved Roche’s Cobas malaria test for use on the Cobas 6800/8800 Systems on Tuesday. The approval marks the first FDA-licensed test to screen blood donors in the U.S. for malaria.

The Cobas malaria test is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. The test is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors are screened as individual samples. The test is not intended for use to diagnose Plasmodium infection, for use on cord blood samples or for use on cadaveric blood specimens.

The approval follows FDA’s March 11 announcement that the Blood Products Advisory Committee will meet May 9 to consider strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure.

Members with questions may contact regulatory@aabb.org.