Roche receives FDA approval for molecular malaria test
The cobas Malaria test is the first FDA-approved molecular test to screen US blood donors for malaria
4 Apr 2024
Product news
Roche has announced the US Food and Drug Administration (FDA) approval of 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.
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 provide comprehensive molecular, serological testing and automation options for donor screening. 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 World Health Organization regions of Southeast Asia, the Eastern Mediterranean, the Western Pacific, and the Americas also report significant numbers of cases and deaths.
About the cobas Malaria test
The cobas Malaria test, a qualitative in vitro nucleic acid screening test, allows for the 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 US. 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 utilizes 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.
About the cobas 6800 and cobas 8800 Systems
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® WNV, cobas® Zika and cobas® Babesia.