“Accurate, rapid Zika diagnostic tests to determine whether someone recently has been infected are critical to ensuring the best health outcomes during the current outbreak,” said Dr. Richard Hatchett, acting director for ASPR’s Biomedical Advanced Research and Development Authority (BARDA). “Identifying Zika cases more quickly helps people take steps to avoid additional transmission that much sooner, which helps protect pregnant women and others at risk of Zika infection.”
The automated laboratory test being developed by DiaSorin uses the company’s LIAISON XL system which can test up to 120 samples at one time and generate results within an hour. Such rapid, high capacity diagnostic tests are urgently needed in the global fight against Zika.
DiaSorin’s test is a serological test for Zika. Serological tests look for antibodies produced by the body’s immune response to viruses. The body produces the earliest response to the Zika virus beginning approximately two weeks after infection and up to three months later. Serological tests are critical in determining whether someone recently was infected with Zika because most people who are infected with the virus do not develop clinical symptoms and are thus unlikely to seek testing while the virus is present in their blood, which other tests can detect.
The contract supports the development of the diagnostic test, design improvements that may be needed, manufacturing preparations and clinical trials that could support its application for FDA clearance.
BARDA is seeking to advance several diagnostic tests for Zika to help improve their availability and potentially lead to lower costs for patients.
Only one in five people infected with Zika develop symptoms and for those that 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. People typically do not get sick enough to go to the hospital, and they very rarely die from Zika infection. 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.
In the absence of congressional funding for the Zika response, HHS has repurposed $374 million from other programs to fund domestic Zika preparedness and response activities. As of August, HHS agencies have obligated $231 million of these repurposed funds. ASPR’s BARDA received $85 million of these reprogrammed funds, and with today’s award, BARDA has obligated $43.9 million of these reprogrammed funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies with private sector partners. In addition, ASPR 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.