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Saturday, April 10th, 2021

HHS supportive of new Zika virus blood screening test

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) announced an agreement on Thursday for a new test to identify whether donated blood is infected with the Zika virus.

The U.S. Food and Drug Administration (FDA) announced the availability of an investigational test to screen blood donations for Zika virus on March 30. The test was developed by Roche Molecular Systems, Inc.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will support a clinical study to evaluate the sensitivity and specificity of the blood donation screening test, which is necessary to apply for FDA approval for commercial marketing.

“BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the U.S. blood supply,” Dr. Richard Hatchett, acting director of BARDA, said. “Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”

Under the one-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects Zika virus. This will also cover samples that are of very low concentration in donor blood.