First Molecular Malaria Test to Screen Blood Donors Approved by FDA

Roche’s cobas malaria test is the first molecular test to screen blood donors for the disease to be approved by the FDA.

The test is designed for use on the cobas 6800/8800 systems and will aid clinicians in reducing potential risks of patient infection from transfused blood products. The cobas malaria test is a qualitative in vitro nucleic acid screening test for the direct detection of the five main species of Plasmodium 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.

Roche submitted its BLA for approval in May 2023. The test will be available in the U.S. at the end of the second quarter of 2024.

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