HHS Awards Back Rapid Zika Lab Tests
The agency's $2.6 million award to DiaSorin Group aims to encourage its development of a high-capacity Zika diagnostic laboratory test, and second, $7 million award is going to OraSure Technologies, Inc.
With concern about the Zika virus rising in Florida — Gov. Rick Scott on Aug. 23 announced the first local case of Zika outside of south Florida, in Pinellas County — the U.S. Department of Health and Human Services announced it is providing $2.6 million to DiaSorin Group, an Italy-based company with U.S. offices in Stillwater, Minn., to further develop a Zika virus test that may help physicians determine more quickly whether a patient was infected recently with the virus.
HHS also announced a separate award to OraSure Technologies, Inc. to advance that company's rapid Zika tests. The company described it as a six-year, multi-phased contract including an initial commitment of $7 million and options for up to an additional $9.6 million to fund the evaluation of additional product enhancements, and clinical and regulatory activities. "We believe the availability of an accurate rapid Zika antibody test will be a valuable tool to address current and potential future outbreaks,” said Douglas A. Michels, president and CEO of OraSure. “We are grateful to BARDA for making this funding available as it will enable us to complete clinical and other activities required to obtain regulatory approvals for this product."
"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 the 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 lab 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. HHS says this type of fast, high-capacity diagnostic test is urgently needed in the global fight against Zika.
The DiaSorin 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," HHS reported. "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."
So far, HHS has repurposed $374 million from other programs to fund domestic Zika preparedness and response activities, and, as of August, HHS agencies have obligated $231 million of those repurposed funds. BARDA received $85 million of that so far has obligated $43.9 million to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies with private-sector partners.
The Miami Herald reported that a total of 42 local Zika infections have been diagnosed in four Florida counties this year.