Roche is launching its in vitro diagnostic test for the Zika virus in countries accepting the CE mark, intended to help screen and protect the global supply of blood donations.
For use on the company’s cobas 6800/8800 automated molecular testing systems, the test detects RNA strands that can be traced back to the Zika virus in human plasma samples.
Though it is mainly spread through bites from infected mosquitoes, it is suspected that transfusions through blood banks could become an additional transmission route similar to other viruses in the family, such as the West Nile virus.
"Together with cobas CHIKV/DENV to screen for chikungunya and dengue viruses, the cobas Zika test provides a solution for preserving blood safety in regions with local outbreaks of these tropical diseases or from donors who may have been exposed while traveling to outbreak areas," said Mario Torres, head of Roche Molecular Diagnostics.
"Launching the cobas Zika test in markets accepting the CE mark expands the emergency preparedness solution for our customers and helps minimize the risk of transmission through infected blood and plasma donations," Torres added.
The test saw an FDA approval and U.S. launch in 2017 in response to the growing public health crisis in the Americas. Since then, it has been used to screen millions of units of donated blood from the U.S. and Puerto Rico, identifying and removing more than 350 potentially infectious donations, the company said.
In announcing the test’s launch, Roche pointed to a report from the World Health Organization detailing three local Zika cases in a town on the south coast of France over the summer, potentially the first episodes of mosquito-based transmission detected in Europe.