WASHINGTON — The Food and Drug Administration on Wednesday endorsed the first test to screen blood donations for the Zika virus.
The screening test still has investigational status, meaning it does not have final approval. But FDA spokeswoman Tara Goodin said the agency has vetted the product and is confident it will work.
“This is a public health emergency, so we are announcing it early,” Goodin said.
The FDA worked closely with manufacturer Roche Molecular Systems in New Jersey to expedite use of the test.
“This type of collaboration, which is typical of the FDA and its US government partners during all public health emergencies, requires a tremendous agency effort,” the FDA’s chief scientist, Dr. Luciana Borio, said in a statement. It “underscores the importance of having adequate resources available to support essential Zika virus response activities.”
Zika has presented new challenges for organizations like the Red Cross and blood banks, in part, because many people infected with the virus show no symptoms and don’t realize they contracted it. Last month, the FDA issued guidelines for blood collection centers to reduce the risk of Zika being transmitted through transfusions. It also recommended that areas with active Zika cases acquire their blood elsewhere.
Once screening of blood donations for the Zika virus starts, the FDA said, places like Puerto Rico, which have stopped collecting blood donations, can resume.
“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 US territories already experiencing active transmission,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA’s statement.
“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,” Marks said.
