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Roche Zika MDx Approved for Blood Screening Under FDA IND Protocol

NEW YORK (GenomeWeb) – Roche announced today that the US Food and Drug Administration has approved the use of Roche's Cobas Zika assay to screen blood samples under an Investigational New Drug application protocol.

The Cobas Zika test is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus in plasma specimens from individual human blood donors. It is designed for use with Roche's fully automated Cobas 6800/8800 Systems, the company said.

"The Cobas Zika test has been specifically designed utilizing the generic Cobas Omni Utility Channel on the Cobas 6800/8800 Systems," Roche Diagnostics COO Roland Diggelmann said in a statement. "These fully automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion."

The test will initially be deployed to screen blood donated locally in Puerto Rico. It is expected that this testing will enable the island to reinstate its own blood services and reduce its reliance on blood importation from other areas in the US, Roche said. The test will subsequently be used to prepare for the potential screening of blood donations in the southern US, which will most likely be affected first if the virus spreads to the US.

Roche noted that the test has not been FDA cleared, and that all testing laboratories will need to be enrolled in and contracted into the clinical trial through the FDA Center for Biologics Evaluation and Research. The company said that it continues to work with regulators around the world to potentially implement the Cobas Zika test for blood screening.