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Roche Gets FDA Nod for Emergency Use of Zika Virus Test

30 August 2016

Now, the FDA recommends "universal testing of donated Whole Blood and blood components for Zika virus in the USA and its territories". On Friday, August 26, 2016, the FDA amended its blood collection guidance, stating that all blood donation in USA states and territories be tested for Zika virus infection, to ensure the safety of the nation's blood supply.

"I think there is scientific rationale for why that is important", she said after a meeting of government officials in Miami Beach, the latest area hit by locally transmitted Zika cases. In March, the FDA approved one of the company's blood tests for detecting Zika under an Investigational New Drug Application protocol that seeks to begin collecting and testing blood samples, according to Yahoo News.

About four out of five of those infected with Zika virus do not become ill, which makes it tough to determine whose blood might carry the pathogen, the agency noted. Doctors recommended blood testing in all 50 states, but many agree Southern states, particularly those closest to Florida, are vital.

While Zika is primarily spread through mosquito bites, there have been reports in Brazil of Zika transmission through transfusion.

SC had confirmed 43 cases of Zika related to travel as of Friday, according to the S.C. Department of Health and Environmental Control. Although most people infected with the virus never develop symptoms, an infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes, the FDA warns.

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About 2,200 Zika cases have been reported in the continental US and more than 13,000 in Puerto Rico, according to the Centers for Disease Control and Prevention.

The American Red Cross has also asked potential blood donors who have traveled to Zika-affected areas to wait 28 days before giving blood.

On the list: Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas.

"Testing labs and the test vendors are working feverishly to allow testing to start on time in the areas subject to the 12 week timeline", said Dr. Louis Katz, in an email. The move is "a strong step forward in protecting our nation's blood supply", Rep. Rosa DeLauro, D-Conn., said in a statement.

Roche Gets FDA Nod for Emergency Use of Zika Virus Test