
Roche to initiate testing for Zika virus under FDA investigational new drug application approval
pharmafile | March 31, 2016 | News story | Manufacturing and Production, Research and Development | Roche, Zika
Roche (SWX: RO) has announced that the US Food and Drug Administration (FDA) has provided approval to initiate the collection and testing of blood samples for screening with the cobas Zika assay under an Investigational New Drug Application (IND) protocol.
This test, designed for use with the cobas 6800/8800 systems, is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors. It has not yet been FDA cleared or approved, but has been authorised under a specific protocol by US Blood screening laboratories.
Roland Diggelman, COO at Roche Diagnostics, comments: “The cobas Zika test has been specifically designed utilising the generic cobas omni Utility Channel on the cobas 6800/8800 systems. 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.
“With the collaboration of the FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe.”
Initially, Roche will deploy in Puerto Rico to screen blood donations collected locally. The second stage for the cobas Zika test will be to prepare for screening of blood donations collected by blood services in the southern United States, which is the area most likely to be impacted by any spread of the Zika virus.
Sean Murray
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