Roche receives FDA approval for the first molecular test to screen for malaria in blood donors

The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malariaMalaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusionRoche is dedicated to saving patients ’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseasesBasel, 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 advance...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news