Siemens to Research Zika Test

The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) www.phe.gov/about/aspr/pages/default in their Biomedical Advanced Research and Development Authority (BARDA) www.phe.gov/about/BARDA/Pages/default.aspx, just signed an agreement for $8.9 million with Siemens Healthineers https://usa.healthcare.siemens.com.

The research project will help further develop a Zika virus test that would expand the testing capacity for the virus and if proven successful, could become available at nearly 2,000 testing sites nationwide.

Only one in five people infected with Zika develop symptoms and for those who do not, the illness usually is mild. For this reason, many people might not realize they have been infected. However, the Zika virus infection during pregnancy can cause serious birth defects, including microcephaly and other severe fetal brain defects.

The automated laboratory diagnostic test being developed by Siemens called the “ADVIA Centaur Zika IgM Assay” is expected to produce an initial result in 58 minutes. The contract supports developing the diagnostic test, manufacturing preparations, and doing clinical studies in order to apply for FDA www.fda.gov clearance.

The test is a serological test, which looks for antibodies produced as part of the body’s immune response to the Zika virus. The body produces an antibody in response to infection to the virus which begins within the first two weeks after infection and continues up to three months after infection.

To help address the public health threat that Zika poses, BARDA has supported the development of Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies with private sector partners. In addition, BARDA along with CDC www.cdc.gov is providing Zika-positive blood samples to help developers validate the accuracy of new diagnostic tests.

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