Roche announced U.S. Food and Drug Administration (FDA) approval of the cobas Malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing risks of patient infection from transfused blood products. 

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 Roche.

A Molecular Test to Screen for Malaria

The cobas Malaria molecular test screens whole blood samples for the five main species of Plasmodium parasites that are known to cause human infection. The potential value of a molecular donor screening test for malaria is to improve both blood safety and availability. The test is intended for use in screening blood, organ and tissue donors.

“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood,” says 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.

Further reading: Roche Showcases New Digital Solutions to Improve Lab Optimization

Malaria Risks from Blood Donors

Globally, a large number of possible donors are excluded from giving blood because of travel to or from residences in malaria-endemic areas. Existing microscopy and serological tests are not sensitive enough to reliably mitigate malaria transfusion risk.

The Roche Blood Safety Solutions offering provides comprehensive molecular, serological testing and automation options for donor screening in the U.S. market.

In 2022, nearly half of the world’s population was at risk of malaria. While sub-Saharan Africa carries a disproportionately high share of the global malaria burden, the World Health Organization regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific and the Americas also report significant numbers of cases and deaths. 

The test will be available in the U.S. at the end of the second quarter of 2024.

Featured image: Roche cobas 6800. Photo: Roche