Roche gets USFDA approval for molecular test to screen for malaria in blood donors
The cobas Malaria test, a qualitative in vitro nucleic acid screening test, allows for direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors.
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) has approved the cobas Malaria test for use on the cobas 6800/8800 Systems. This approved test can aid healthcare professionals in reducing potential 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.
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.
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.
The cobas Malaria test, a qualitative in vitro nucleic acid screening test, allows for direct detection of Plasmodium RNA and DNA in whole blood samples from individual human donors. The test, which can be performed with other routine blood donor screening tests, is designed for use on the cobas 6800/8800 Systems in the U.S. The test is not intended for use to diagnose Plasmodium infection, for use on cord blood samples or for use on cadaveric blood specimens. The test utilises the Roche Whole Blood Collection Tube, which allows for direct draw from the donor and is loaded directly onto the cobas 6800/8800 Systems for increased workflow efficiency.
Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship. The current molecular donor screening assay menu includes cobas MPX, cobas DPX, cobas HEV, cobas WNV, cobas CHIKV/DENV, cobas Zika and cobas Babesia (not all tests are available in the U.S.).
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