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Roche Applies CE Mark to Zika Screening Test

NEW YORK – Roche announced Monday the launch of its Cobas Zika test in countries that accept the CE mark.

The in vitro nucleic acid screening test detects Zika virus RNA in samples of human plasma and is intended to be used for screening blood donations with Roche's fully automated Cobas 6800/8800 systems.

"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," Mario Torres, head of Roche Molecular Diagnostics, said in a statement.

The US Food and Drug Administration approved the test in 2017 after Roche worked with the agency to develop the test. Roche's Zika test has helped identify and remove more than 350 potentially infectious donations from the blood supply, according to the company.

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