The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response today announced a $2.6 million agreement with DiaSorin Group, an Italy-based company with U.S. offices in Stillwater, Minnesota, to further develop a Zika virus test that may help physicians determine more quickly whether a patient was infected recently with Zika virus.
“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.