FDA Approves Test to Screen Donated Blood for Zika

From Drugs.com - October 6, 2017

FDA Approves Test to Screen Donated Blood for Zika

FRIDAY, Oct. 6, 2017 -- The U.S. Food and Drug Administration has approved a new test -- called the cobas Zika test -- to screen donated blood for the Zika virus.

"Today's action represents the first approval of a Zika virus detection test for use with screening the nation's blood supply," Dr. Peter Marks said Thursday in an agency news release. Marks is director of the FDA's Center for Biologics Evaluation and Research.

"Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. Today's approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis, and ensure the safety of blood in the U.S. and its territories."

Zika is spread mainly through mosquitoes carrying the virus. It can also be transmitted through sexual contact or blood transfusions.

In August of last year, the FDA advised all states to screen all donated blood and blood products with an experimental screening test accessible under an investigational new drug (IND) application.

An IND allows the FDA to authorize use of an experimental drug in emergency situations. The FDA recommended that an experimental Zika screening test be used until an approved test became available.

Several blood collection centers opted to use the cobas Zika test, which is made by Roche Molecular Systems.


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