Roche receives FDA approval for one of the first molecular tests to screen for malaria in blood donors

March 28, 2024
Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion.

Roche announced the U.S. Food and Drug Administration (FDA) approval of the cobas Malaria test for use on the cobas 6800/8800 Systems.

This approved test can aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The cobas Malaria test provides a highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply. 

The cobas Malaria molecular test screens whole blood samples for the five main species of Plasmodium parasites that are known to cause human infection. The potential value of a molecular donor screening test for malaria is to improve both blood safety and availability. The test is intended for use in screening blood, organ and tissue donors.

The test will be available in the U.S. at the end of the second quarter of 2024.

Roche release