FDA OKs Roche’s Test to Screen Blood Donors for Malaria

Roche has earned U.S. Food and Drug Administration (FDA) approval for the cobas Malaria test to run on the company’s cobas 6800/8800 systems.
 
The qualitative in vitro nucleic acid screening test helps to reduce potential patient infection risks from transfused blood products. The cobas Malaria test aims to help ensure infected blood units are removed from the blood supply.
 
Globally, a large number of potential donors are not allowed to give blood because of travel to or from residences in malaria-endemic areas. Current microscopy and serological tests aren’t sensitive enough to reliably mitigate malaria transfusion risk.
 
The molecular test screens whole blood samples for the five main Plasmodium parasite species that cause human infection. The test is intended for screening blood, organ, and tissue donors, offering potential value to improve blood safety and availability.
 
In 2022, almost half of the world’s population was at risk of malaria. Sub-Saharan Africa carries a disproportionately high share of the global malaria burden, but the WHO regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also reported significant numbers of cases and deaths
 
There were an estimated 249 million cases of malaria in 2022, and the estimated number of malaria deaths was 608,000.
 
Roche said the test will become available in the U.S. at the end of Q2 2024. Approval in CE-marked countries is expected later this year.
 
“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.”
 
The company advised the test isn’t intended for use to diagnose Plasmodium infection, on cord blood samples, or on cadaveric blood specimens.
 
Earlier this year, Roche began a $295 million deal to acquire LumiraDx’s point-of-care technology business.