Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Roche receives FDA approval for the first molecular test to screen for malaria in blood donors | |||||||||||||||
By: GlobeNewswire - 26 Mar 2024 | Back to overview list |
||||||||||||||
Basel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. 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. “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. 2 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. About the cobas Malaria test About the cobas 6800 and cobas 8800 Systems About Malaria Malaria is preventable and curable. There are 5 parasite species that cause malaria in humans, and 2 of these species – Plasmodium falciparum and Plasmodium vivax – pose the greatest threat. About Roche In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. Roche Global Media Relations
Roche Investor Relations
Attachment |
|||||||||||||||
|
|||||||||||||||
Copyright 2024 GlobeNewswire | Back to overview list |