FDA Approves First Molecular Test to Screen Blood Donors for Malaria

The Food and Drug Administration (FDA) has approved the cobas^® Malaria, a qualitative PCR test, for use on the cobas^® 6800/8800 systems to detect Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors.

The cobas Malaria test is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating. The test is not intended for use: as an aid in diagnosis of Plasmodium infection; on samples of cord blood; or on cadaveric blood specimens. 

The approval was based on data from performance studies which showed that the cobas Malaria test demonstrated 100% clinical sensitivity for P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi. Moreover, the test demonstrated 100% clinical specificity in a zero-prevalence population.

“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 health care professionals a reliable tool for donor screening and improving the safety of patients worldwide.”

The cobas Malaria test will be available at the end of the second quarter of 2024.