First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety

Other transmission modes include blood transfusions, organ transplants, and shared needles or syringes contaminated with infected blood. Although the largest burden of malaria is in sub-Saharan Africa, Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also report many cases and deaths. Because of the risk of malaria transmission, many potential blood donors who have traveled to or lived in malaria-endemic areas are currently ineligible to donate blood. The existing methods for detecting malaria in blood, such as microscopy and serology, lack the necessary sensitivity to ensure the safety of blood transfusions. Now, the first FDA-approved molecular test to screen U.S. blood donors for malaria marks a significant advancement in maintaining a safe global blood supply.

Roche (Basel, Switzerland) has obtained FDA approval for the cobas Malaria test for use on the cobas 6800/8800 Systems. This test enables healthcare providers to minimize the risks of malaria transmission through blood transfusion by identifying blood units infected with malaria. It screens for the five primary species of Plasmodium parasites that cause malaria in humans, enhancing both the safety and availability of blood supplies. Designed for screening blood, organs, and tissue donations, the cobas Malaria test is a qualitative in vitro test that detects Plasmodium RNA and DNA in whole blood samples from individual donors. It is essential to note that the test is not for diagnosing Plasmodium infections, nor is it applicable to cord blood samples or cadaveric blood specimens. Utilizing the Roche Whole Blood Collection Tube, the test streamlines the workflow by allowing direct blood draws from donors and immediate processing on the cobas 6800/8800 Systems.

“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood," said Matt Sause, CEO of Roche Diagnostics. “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.”