FDA Recommends Pooled of Blood Testing for Zika Virus

The U.S. Food and Drug Administration (FDA) revised recommendations for testing donated blood for Zika virus. The agency will now allow pooled testing of blood donations, rather than universal nucleic acid testing of individual units of blood. The agency said pooled testing is both more cost effective and "less burdensome" for blood establishments, but that "when certain threshold conditions are present," such as an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic are, a return to individual testing may be triggered. The final guidance still requires blood establishments to test all donated whole blood and blood components for Zika virus using a nucleic acid test. Since 2016 two assays have been approved under investigational new drug applications—the cobas Zika (Roche Molecular Systems, Inc.) and the Procleix Zika Virus Assay (Grifols Diagnostic Solutions, Inc.). In May of this year, the FDA approved an additional claim for Roche’s Cobas Zika test for pooled testing of blood or plasma donations. U.S. Recommends Expansion of Newborn Screening Health and Human Services Secretary Alex Azar approved the addition of spinal muscular atrophy to the list of conditions for which the U.S. government recommends newborn screening. Approximately 4 million infants are […]