HHS supporting study of Zika virus blood screening test
April 22, 2016 - 10:51 AM
The development of a test to identify whether donated blood is
infected with the Zika virus is moving forward with support from the
U.S. Department of Health and Human Services’ Office of the Assistant
Secretary for Preparedness and Response (ASPR) and the Office of the Assistant Secretary for Health (OASH).
On March 30, the U.S. Food and Drug Administration (FDA) announced
the availability of an investigational test to screen blood donations
for Zika virus. The test is manufactured by Roche Molecular Systems,
Inc., based in Branchburg, New Jersey.
Today’s agreement with ASPR’s Biomedical Advanced Research and Development Authority (BARDA)
supports a clinical study to evaluate the sensitivity and specificity
of the blood donation screening test in its actual use. The study 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,” said Dr. Richard Hatchett, BARDA’s
acting director. “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.”
Most people infected with Zika do not have symptoms and may donate
blood not knowing that they are infected. There have been reports of
probable cases of transfusion transmission of Zika virus in Brazil, and
those cases currently are being investigated. Having an accurate blood
donation screening test will help ensure that infected blood is removed
from the blood supply.
Under the one-year, $354,500 contract, Roche will study blood samples
to confirm whether the test accurately and reliably detects and
identifies Zika virus, even when present in very low concentration in
Advancing the development of the Zika virus blood donation screening test is part of BARDA’s integrated portfolio for
advanced research and development, innovation, acquisition, and
manufacturing of vaccines, drugs, diagnostic tools, and
non-pharmaceutical products for public health emergency threats. These
threats include chemical, biological, radiological, and nuclear agents,
pandemic influenza, emerging infectious diseases, and antimicrobial
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