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FDA Diagnostics Approvals | 2024 | FDA Approvals | iPharmaCenter

Roche secures FDA authorization for pioneering molecular assay to screen for malaria in blood donors

The Cobas Malaria test marks a groundbreaking milestone as the inaugural FDA-approved molecular assay for screening U.S. blood donors for malaria Malaria, a severe and potentially lethal parasitic affliction, primarily disseminated by mosquitoes, can also be transmitted through blood transfusion.


The U.S. Food and Drug Administration (FDA) endorsed for the Cobas® Malaria test compatible with the Cobas® 6800/8800 Systems. This endorsed assay serves as a pivotal tool for healthcare providers in mitigating potential infection risks stemming from transfused blood components.


The Cobas Malaria molecular assay scrutinizes whole blood specimens for the five primary species of Plasmodium parasites accountable for human infection. The intrinsic value of a molecular screening test for malaria in donors lies in enhancing both blood safety and availability. Designed for deployment in screening blood, organ, and tissue donors, this test is poised to significantly impact donation practices, as a considerable number of potential donors are barred from blood contribution due to travel to or from malaria-endemic regions. Conventional microscopy and serological assays fall short in reliably mitigating the risk of malaria transmission through transfusion.


Roche's Blood Safety Solutions portfolio stands as the most extensive array of molecular, serological testing, and automation alternatives for donor screening within the U.S. marketplace.


In 2022, nearly half of the global populace faced malaria susceptibility. While sub-Saharan Africa shoulders a disproportionately substantial burden of malaria cases, the WHO-designated regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also register significant caseloads and fatalities. The year 2022 recorded an estimated 249 million malaria instances, with 608,000 attributed deaths.

Notably, the African Region accounted for 94% and 95% of malaria cases and fatalities, respectively.

Anticipated to debut in the United States by the conclusion of Q2 2024, the test's regulatory approval across CE-marked territories is on the horizon later this year.

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