• The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria
• Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion
• Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases
  
  

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," 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.”

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 the most comprehensive molecular, serological testing and automation options for donor screening in the US 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 WHO regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also report significant numbers of cases and deaths. There were an estimated 249 million cases of malaria in 2022, and the estimated number of malaria deaths stood at 608,000. In 2022, the African Region was home to 94% and 95% of malaria cases and deaths, respectively. ²

The test will be available in the United States at the end of Q2 2024. Approval in CE-marked countries is anticipated later this year.