The U.S. Department of Health and Human Services has awarded $4.1 million to Hologic for the development of a blood-screening test to detect Zika in the blood supply.
Under the one-year agreement, Hologic, the Marlborough, Massachusetts-based diagnostics and imaging company, will advance the development of its Procleix Zika Virus Assay, which is designed to detect Zika virus ribonucleic acid – RNA – in donated blood plasma.
[Also: Zika funds are running out, HHS Secretary Burwell tells Congress]
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.
The test was granted investigational new device status on June 17 by the FDA and the contract could be extended up to 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 FDA for commercial marketing.
It is the second blood-screening test the agency is helping advance to test donated blood for Zika.
In April, HHS officials 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.
[Also: CDC says widespread Zika infections are unlikely]
Most people infected with Zika do not develop clinical symptoms and might donate blood not knowing that they are infected, HHS officials noted.
“Accurate blood-screening tools are vital to protecting our nation’s blood supply from Zika,” Richard Hatchett, acting director of HHS’ Biomedical Advanced Research and Development Authority, said in a statement.
To respond to the Zika virus outbreak, HHS repurposed $374 million for domestic Zika response and preparedness activities. As of August, HHS agencies had obligated $222 million of these repurposed funds.
Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com
