HHS Backs Another Zika Test
The automated laboratory diagnostic test being developed by Siemens Healthineers would produce an initial result in 58 minutes. The $8.9 million contract supports the development of the diagnostic test, manufacturing preparations, and clinical studies that could support its application for clearance from FDA.
The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response has agreed to provide $8.9 million to Siemens Healthineers (Tarrytown, N.Y.) to continue developing a Zika virus test that, if testing is successful, could be available at nearly 2,000 testing sites nationwide. "This new diagnostic test will greatly enhance our domestic testing capacity and speed the availability of test results to help more people know whether they recently have been infected with the Zika virus, which can have devastating effects for pregnant women and their babies," said Rick Bright, director of ASPR's Biomedical Advanced Research and Development Authority, known as BARDA.
The automated laboratory diagnostic test being developed by Siemens Healthineers is the ADVIA Centaur Zika IgM Assay; it would be expected to produce an initial result in 58 minutes, according to HHS, which reported the contract supports the development of the diagnostic test, manufacturing preparations, and clinical studies that could support its application for clearance from FDA.
This is the second "high-throughput laboratory diagnostic test" for Zika that BARDA has supported. They reduce the time between testing and patients receiving test results when compared with manual testing.
BARDA has supported the development of Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies with privater partners and is working with CDC to provide Zika-positive blood samples to help developers validate the accuracy of new diagnostic tests.