CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 1, 2024—Roche announced FDA approval of the Cobas Malaria test, a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors. The test can be performed with other routine blood donor screening tests and is designed for use on the Cobas 6800/8800 systems in the United States.
“As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood,” Matt Sause, CEO of Roche Diagnostics, said in a press statement. “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.”