Government and Regulations

ASPR Lends Support to New Screening Test for Zika

$4.1 million is being put to a 1-year agreement to administer a second screening test to detect Zika in donated blood.


 

Reports in Brazil of Zika transmitted via blood transfusion call attention to the need for better ways to protect the blood supply. To that end, a blood screening test is getting a boost from the Office of the Assistant Secretary for Preparedness and Response (ASPR), with a $4.1 million agreement with Hologic, Inc., of Marlborough, Mass. This is the second screening test ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is helping advance that may be used to test donated blood for Zika. Last April, ASPR announced support of a clinical study of a test developed by Roche Molecular Systems, Inc., of Branchburg, New Jersey.

Under the 1-year agreement, Hologic will advance development of its Procleix Zika Virus Assay, which is designed to detect Zika virus RNA in donated blood plasma up to 7 days post-infection. It runs on Hologic’s Panther automated system, which is already FDA cleared for some infectious disease in vitro diagnostic testing.

The contract could be extended to 18 months with an additional $6.2 million to support the clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, a necessary step before FDA approval.

The money is part of the $374 million HHS has repurposed for domestic Zika response and preparedness activities. BARDA has obligated $41.4 million of these “reprogrammed” funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.

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