August 20, 2016 6:28 pm | Updated 2 months ago.
The US Department of Health and Human Services has signed a USD 4.1 million one year agreement with Massachusetts-based diagnostic and imaging company Hologic for supporting clinical trials of Procleix Zika Virus Assay to detect the Zika virus. This will help evaluate the sensitivity and specificity of the blood screening test in its actual use, which is necessary before it is considered for approval by the FDA for commercial marketing.
This is second blood -screening test which Health and Human Services is helping advance to test donated blood for Zika. Earlier in April this year HHS extended support for a clinical study of Zika blood-screening test developed by Roche Molecular Systems of Branchburg, New Jersey .
The Procleix Zika Virus Assay detects the Zika virus RNA up to seven days post-infection in plasma from people who have either lived in or have visited areas of active Zika transmission.
Most people infected with Zika do not develop clinical symptoms and might donate blood oblivious of their infection. Accurate blood-screening tools are critical to keeping the national blood banks protected.
Date of Publication: August 10, 2016