On Mar. 26, 2024, Roche announced that the U.S. Food and Drug Administration (FDA) had approved 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 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.

Globally, a large number of possible donors are excluded from giving blood because of travel to or from residences in malaria-endemic areas. Existing microscopy and serological tests are not sensitive enough to reliably mitigate malaria transfusion risk.

In 2022, nearly half of the world’s population was at risk of malaria. While sub-Saharan Africa carries a disproportionately high share of the global malaria burden, the WHO regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also report significant numbers of cases and deaths. There were an estimated 249 million cases of malaria in 2022, and the estimated number of malaria deaths stood at 608,000. In 2022, the African Region was home to 94% and 95% of malaria cases and deaths, respectively. 

The test will be available in the United States at the end of the second quarter 2024. Approval in CE-marked countries is anticipated by the end of  year.