Roche receives FDA approval for the first molecular test to screen for malaria in blood donors - Seite 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
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.