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Roche wins FDA approval for first molecular malaria blood donor screening test

The company is pitching the test as a way to improve the safety and availability of blood.

Roche has received Food and Drug Administration approval for the first molecular test to screen U.S. blood donors for malaria, the company said Tuesday.

In 2022, the FDA recommended preventing people from giving blood for a time after they return from an area with malaria because there was no licensed test to screen donors. Other countries including Australia, England and France use antibody testing to avoid excluding potential donors.

Roche’s Cobas malaria molecular test screens whole blood samples for the five main species of parasites that cause infections. The company is pitching the test as a way to improve the safety and availability of blood.

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