FDA approves Roche’s test for malaria in blood donors

Betsy Goodfellow | April 2, 2024 | News story | Business Services FDA, Infections and infestations, blood donation, malaria 

Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas Malaria test for use on the cobas 6800/8800 systems.

The test is intended to help healthcare professionals in reducing the risk of patient infection from blood transfusions, as the cobas Malaria test ‘provides a highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply’, according to the company’s press release.

The test is able to screen whole blood samples for the five main species of Plasmodium parasites that cause human infection, and is intended to improve both blood safety and availability. It will be used to screen blood, organ and tissue donors.

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It is expected that this test will be available towards the end of the second quarter of 2024, with approval in CE-marked countries expected later on in the year.

Matt Sause, chief executive officer of Roche Diagnostics, commented: “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood. The approval of cobas Malaria represents a significant advancement in malaria detection, offering healthcare professionals a reliable tool for donor screening and improving the safety of patients worldwide.”

Betsy Goodfellow

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