Today, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response announced a $4.1 million agreement with Hologic, of Marlborough, Massachusetts, to advance the development of a blood screening test that will help detect the presence of Zika in the blood supply.
This is the second blood screening test ASPR’s Biomedical Advanced Research and Development Authority (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, of Branchburg, New Jersey, to confirm whether that test accurately detects the virus in donor 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 (RNA) in donated blood plasma.
The contract could be extended up to a total of 18 months and $6.2 million to support the clinical study to evaluate the sensitivity and specificity of the blood donation screening test in its actual use, which is necessary before it may be approved by the U.S. Food and Drug Administration (FDA) for commercial marketing if additional funding were identified for this activity.
The test was granted investigational new device status on June 17 by the FDA. The Procleix Zika Virus Assay detects Zika virus RNA up to seven days post-infection in plasma from individuals who live in or have visited areas of active Zika transmission. The test runs on Hologic’s Panther automated system, which is FDA-cleared for some infectious disease in vitro diagnostic testing and which accepts both random access and continuous load testing of blood samples.
Most people infected with Zika do not develop clinical symptoms and might donate blood not knowing that they are infected. There have been reports of blood transfusion transmission cases of Zika in Brazil, and those cases currently are being investigated. Having accurate blood donation screening tests will help ensure infected blood is removed from the blood supply.
To respond to the Zika virus outbreak, HHS repurposed $374 million for domestic Zika response and preparedness activities. As of August, HHS agencies have obligated $222 million of these repurposed funds. ASPR’s BARDA received $85 million of these reprogrammed funds, and with today’s award, 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. In addition, ASPR is providing Zika-positive blood samples to developers to overcome a hurdle in validating the accuracy of new diagnostic tests.
Advancing the development of blood donation screening tests, diagnostics, and vaccines for Zika 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 resistance.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.