HHS Awards $4.1 Million to Developer of Zika Blood Screening Test
"Accurate blood-screening tools are vital to protecting our nation's blood supply from Zika. This test may provide another tool laboratories can use to identify infected blood donations to help ensure patients' safety," said Dr. Richard Hatchett, BARDA's acting director. "At the same time, we are pursuing promising diagnostic tools and vaccines to identify and prevent Zika virus infections."
The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response announced it has made a $4.1 million agreement with Hologic, Inc. of Marlborough, Mass., to advance the development of a blood screening test that will help detect the presence of Zika in the blood supply. HHS reported this is the second blood screening test ASPR's Biomedical Advanced Research and Development Authority, known as BARDA, is helping advance that may be used to test donated blood for Zika. In April, ASPR announced support of a clinical study of a Zika blood screening test developed by Roche Molecular Systems, Inc. to confirm whether that test accurately detects the virus in donors' blood.
"Accurate blood-screening tools are vital to protecting our nation's blood supply from Zika. This test may provide another tool laboratories can use to identify infected blood donations to help ensure patients' safety," said Dr. Richard Hatchett, BARDA's acting director. "At the same time, we are pursuing promising diagnostic tools and vaccines to identify and prevent Zika virus infections."
Under the one-year agreement, Hologic will advance the development of its Procleix Zika Virus Assay, which is designed to detect Zika virus ribonucleic acid in donated blood plasma. The contract could be extended up to a total of 18 months and $6.2 million to support a clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, which is necessary before it can be approved by the U.S. Food and Drug Administration for commercial marketing, if additional funding is identified for this activity.
The test was granted investigational new device status on June 17 by FDA.