August 26, 2016 / 6:21 PM / 2 years ago

UPDATE 2-FDA recommends Zika testing for all blood donated in US

(Adds FDA comments)

Aug 26 (Reuters) - The U.S. Food and Drug Administration recommended on Friday that all blood donated in the United States and its territories be tested for Zika virus, as it moves to prevent transmission of the virus through the blood supply.

The agency’s move to expand its previous guideline for blood screening comes after Florida officials on Tuesday announced the first case of Zika transmitted by mosquitoes in Pinellas County, some 265 miles from Miami, where the first locally transmitted U.S. cases were reported.

In a statement, the agency said testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and that it has shown to be beneficial in identifying donations infected with Zika virus.

Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced, the FDA said.

Zika was detected in Brazil last year and has since spread across the Americas. The virus poses a risk to pregnant women because it can cause severe birth defects. It has been linked to more than 1,800 cases of microcephaly in Brazil.

“The transfusion of a pregnant woman with blood infected with the Zika virus could have terrible consequences,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a conference call with reporters.

Health officials warned pregnant women last week not to travel to Miami Beach after Florida confirmed the mosquito-borne Zika virus was active there.

Marks said two companies have been granted special approval to have their tests used to screen the blood supply. Those companies are Hologic Inc and Roche Molecular Systems.

Marks said the FDA has already reviewed data submitted by these companies and is confident these investigational tests “will perform appropriately” in this setting.

The agency had recommended in February that blood should no longer be collected from regions where the Zika virus is circulating, and that blood needed for transfusions be obtained from areas of the country without active transmission.

Shares of Hologic rose 44 cents, or 1.1 percent, to $38.87 in afternoon trade on Nasdaq.

Reporting by Ankur Banerjee in Bengaluru and Julie Steenhuysen in Chicago; Editing by Shounak Dasgupta, Saumyadeb Chakrabarty and Bernard Orr

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