The FDA has approved a Zika detection test for blood donations created by Roche (RHHBY) as the government tries to stave off the relatively novel disease.
"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 enrue the safety of blood in the U.S and its territories" states Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research.
Since the Zika virus can be transferred both by mosquitos and through sexual contact without any symptoms, a test for the disease is a necessity, Zika can cause neurological damage in adults and birth defects in unborn children.
Roche cinched the deal by testing blood in 5 different laboratory settings and had a certainty rate of 99%. The test is specifically designed for Roche's molecular diagnostic system, cobas.
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