The mosquito-borne Zika virus disease is linked to serious birth defects. It can cause temporary paralysis in adults and brain damage in infants born to infected mothers. The pathogen can also be sexually transmitted. It is important that blood donations are screened accurately to rule out infection by this dangerous virus. Roche Diagnostics recently announced that the U.S. Food and Drug Administration (FDA) has nodded approval for the company to initiate collection and test blood samples for screening Zika with its cobas® Zika test. The assay can be used under an Investigational New Drug Application (IND) protocol for screening donated blood in areas with active mosquito-borne transmission of Zika virus.
To prevent Zika from contaminating the blood supply, the FDA issued certain guidelines last month addressing blood donation. The agency has recommended that places where Zika is circulating should get their blood supply from parts of the U.S. where the virus isn’t spreading locally. As a result, local blood collection in Puerto Rico was suspended earlier this year.
The latest development is the FDA’s approval to use Roche’s cobas® Zika test to screen blood donations collected locally in Puerto Rico and later in the United States. This testing is expected to help reinstate the blood services in Puerto Rico and reduce its dependency on blood importation from other areas in the U.S. This test will be used in the second stage to prepare for screening of blood donations collected by blood services in the southern U.S., which is most likely to be impacted by any spread of the virus. Cobas® Zika test for use on 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.
Roland Diggelmann, COO Roche Diagnostics said, “As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies. With the collaboration of the FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe.”