The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria
Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion
Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases
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
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.
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® HEV, cobas® WNV, cobas® CHIKV/DENV, cobas® Zika and cobas® Babesia (not all tests are available in the U.S.).
About Malaria
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria typically experience high fever, shaking chills and flu-like symptoms. The disease can also be transmitted through blood transfusion, organ transplant or the shared use of needles or syringes contaminated with blood.1
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
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan