April 12, 2017
HHS sponsors new Zika diagnostic test, boosting national testing capacity
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today announced an $8.9 million agreement with Siemens Healthineers, a Tarrytown, New York-based company to further develop a Zika virus test that could expand the nation’s testing capacity for the virus and potentially lead to lower costs for patients.
If the test proves successful, it could become 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 (BARDA).
The automated laboratory diagnostic test being developed by Siemens Healthineers, to be called the ADVIA Centaur Zika IgM Assay, would be expected to produce an initial result in 58 minutes. The contract supports the development of the diagnostic test, manufacturing preparations and clinical studies that could support its application for FDA clearance.
Siemens Healthineers ADVIA Centaur Zika IgM Assay is the second high-throughput laboratory diagnostic test for Zika that BARDA has supported. These tests reduce the time between testing and patients receiving test results compared to manual testing.
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 immunoglobulin M, or IgM, antibody in response to infection by the Zika virus beginning within the first two weeks after infection and continuing up to three months after infection. The intended use of this serologic test is to determine whether someone was recently infected with Zika virus. It may augment other types of tests that specifically identify the nucleic acid (RNA) of the virus. Only 1 in 5 people infected with Zika develop symptoms and for those who do, the illness usually is mild. The most common symptoms – fever, rash, joint pain, and conjunctivitis, or red eyes— typically last for several days to a week. For these reasons, many people might not realize they have been infected. However, Zika virus infection during pregnancy can cause serious birth defects, including microcephaly and other severe fetal brain defects.
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 the Centers for Disease Control and Prevention, is providing Zika-positive blood samples to help developers validate the accuracy of new diagnostic tests.
Advancing the development of Zika diagnostics is part of BARDA’s integrated portfolio for the advanced research and development, innovation, acquisition, and manufacturing of medical counter measures — including vaccines, drugs, diagnostic tools, and non-pharmaceutical products — to 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.