The FDA will move away from testing all donated blood and blood products for Zika virus, the agency said Friday.
Citing the decrease in Zika cases in the U.S., as well as cost effectiveness and a desire to make the process less burdensome, the FDA revised its interim guidance from August 2016, which stated that all blood and blood products should be tested for the virus.
The agency released a revised final guidance document explaining the new policy. They stated "in order to comply with applicable testing regulations, blood establishments must continue to test all donated Whole Blood and blood components for Zika virus using a nucleic acid test." But they added that pooled donation using an FDA-licensed screening test may be sufficient, unless there is a higher risk of local mosquito-borne transmission of the virus in a specific geographic area, which would trigger the need for individual donation testing.
"When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply," Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, said in a statement. "Now, given the significant decrease in cases of Zika virus infection in the U.S. and its territories, we are moving away from testing each individual donation to testing pooled donations."
When the interim guidance emerged, the U.S. was less than a month removed from the first cases of locally transmitted Zika virus in south Florida. But the Red Cross protested these interim guidelines at a meeting that November with the FDA, saying that this was cost prohibitive and burdening hospitals, and that the process had uncovered only "a handful" of donations that tested positive for the virus.
Bolstering this argument was a study published in the New England Journal of Medicine in May that found just nine confirmed positive cases of Zika among almost four million donations, and that the projected annual cost for national screening would be $137 million.
The FDA said they will "continue to monitor the situation closely, and as appropriate, and will reconsider what measures are needed to maintain the safety of the blood supply," Marks said.