FDA allows use of investigational test to screen blood donations for Zika virus

FDA News Release

• For Immediate Release: March 30, 2016

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The U.S. Food and Drug Administration today announced the availability of an investigational test to screen blood donations for Zika virus. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus.

“The availability of an investigational test to screen donated blood for Zika virus is an important step forward in maintaining the safety of the nation’s blood supply, especially for those U.S. territories already experiencing active transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply.”

On Feb. 16, the FDA issued guidance to blood establishments to reduce the risk of transfusion-transmitted Zika virus. In the guidance, the FDA recommends that areas with active transmission of Zika virus obtain Whole Blood and blood components from areas without active transmission of Zika virus. As a result of this recommendation, local blood collection in Puerto Rico was suspended, and on March 7, the Department of Health and Human Services announced that it arranged for shipments of blood products from the continental U.S. to Puerto Rico.

The FDA guidance further states that establishments in areas with active Zika transmission may collect locally if a licensed or investigational test for screening donated blood is available. Once screening of blood donations for Zika virus using the investigational test begins, blood establishments in Puerto Rico may resume collecting donations of Whole Blood and blood components. However, the FDA’s recommendations for Zika blood donor deferrals remain in place.

The FDA, the Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority, and the Centers for Disease Control and Prevention are working to assist product manufacturers with development of Zika virus blood donation screening tests to help protect the nation’s supply of blood and blood components during this outbreak.  

“The close collaboration between the FDA and the product manufacturer was essential to expediting availability of this investigational test,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “This type of cooperation, which is typical of the FDA and its U.S. government partners during all public health emergencies, requires a tremendous agency effort and underscores the importance of having adequate resources available to support essential Zika virus response activities.”

The test is manufactured by Roche Molecular Systems, Inc., based in Branchburg, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Use of investigational test allows blood establishments in Puerto Rico to resume collecting Whole Blood and blood component donations