The US Food and Drug Administration (FDA) has approved a molecular test from Roche Diagnostics that screens blood donors for malaria.
The agency’s approval is for the use of Roche’s cobas Malaria test on the polymerase chain reaction (PCR)-based cobas 6800/8800 systems.
The approval by the FDA means this is the first test that allows healthcare professionals to screen for the disease in blood, organ, and tissue donors.
The FDA has strict guidelines to prevent transfusion-transmitted malaria. People who have recently travelled to a country with malaria or those who have recently been diagnosed with the disease cannot donate blood for a certain period.
Roche states that existing microscopy and serological tests used to mandate these rules are not sensitive enough to reliably mitigate malaria transfusion risk. The Centers for Disease Control and Prevention (CDC) says microscopic examination is the “gold standard” but the lack of tests performed annually by scientists means it could lack optimal proficiency.
Roche’s cobas Malaria test is an in vitro nucleic acid screening test for the five main species of Plasmodium parasites that are known to cause the disease in humans.
There were an estimated 249 million malaria cases globally in 2022. Africa carries a disproportionately high share of the global disease burden. In the US, there are around 2,000 cases a year according to the CDC – nearly all are linked to travel to malaria-endemic countries.
Roche Diagnostics’s CEO Matt Sause said: “As the first FDA-approved blood screening test for malaria, this represents an important step forward in safeguarding the global supply of donated blood.”
The company plans to roll out the test in the US at the end of Q2 2024. CE mark approval in Europe is currently under review.
The global polymerase chain reaction market is estimated to grow to $1.2bn by 2033, up from $733m in 2023, according to a report by GlobalData.
Alongside its cobas in vitro diagnostic test, Roche has Lariam (mefloquine) as an FDA-approved drug for the treatment of malaria.
Studies have also shown the potential of rapid saliva tests to detect the disease early in patients.
