The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today announced a $7 million contract with Orasure Technologies, Inc. of Bethlehem, Penn., to further the development of a Zika virus test that potentially can provide results in about 30 minutes at a doctor’s office. The agreement is the first point-of-care Zika test ASPR has sponsored.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide the funding over the next three years to support the product’s continued development, manufacturing preparations and a clinical testing, which are necessary to apply for clearance from the U.S. Food and Drug Administration (FDA) to commercially market the product.
ASPR/BARDA has the option to fund additional work through 2022 for up to a total of $16.6 million if additional funding were identified for this activity. During development, the company also could request that FDA issue an Emergency Use Authorization for emergency use of the diagnostic test.
“We are working aggressively with private sector partners to develop and make available diagnostic tests, vaccines and blood screening products needed to better protect our nation against the public health threat of Zika,” said Dr. Richard Hatchett, BARDA acting director. “Pregnant women and others at risk who are recommended for Zika testing need accurate diagnostic tests that provide results quickly to guide decisions about their treatment.”
Orasure’s test is a lateral flow serological test. A lateral flow test is similar to a home pregnancy test but uses a few drops of blood instead of urine. Whereas other tests detect Zika virus cells in blood, serological tests look for antibodies produced by the body’s immune response to viruses. The body produces antibodies to the Zika virus beginning approximately two weeks after infection and up to three months later when the virus is no longer present in a person’s blood.
Serological tests are critical in determining whether someone recently was infected with the Zika virus 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 still present in their blood.
Lateral flow tests can be performed in a doctor’s office. Because these tests do not need to be sent to a laboratory for results, avoiding long delays in getting test results and the anxiety associated with the uncertainty during wait times.
In addition to this lateral flow test, BARDA is supporting the development of several other diagnostic tests for Zika to make them available sooner and at potentially lower cost than if the tests were developed without federal funding. These tests include serological tests being developed by DiaSorin Group and InBios designed for use in commercial and health care facility laboratories, and a molecular test being developed by Hologic for use in blood banks. FDA recently issued Emergency Use Authorizations for emergency use of the InBios and Hologic tests.
Most people do not develop clinical symptoms and might not suspect they are infected. The most common symptoms of Zika are fever, rash, joint pain, and conjunctivitis, or red eyes. The illness usually is mild with symptoms lasting for several days to a week. People typically do not get sick enough to go to the hospital, and they very rarely die of Zika. For this reason, many people might not realize they have been infected. However, Zika virus infection during pregnancy can cause a serious birth defect called microcephaly, as well as other severe fetal brain defects.
To respond to the Zika virus outbreak, HHS reprogrammed $374 million for domestic Zika response and preparedness activities. As of August, HHS agencies have obligated more than $248 million of these reprogrammed funds. ASPR’s BARDA received $85 million of the reprogrammed funds; with today’s award, BARDA has obligated more than $50 million of the funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners. In addition, ASPR is providing Zika-positive blood samples to developers to aid in validating the accuracy of new diagnostic tests.
In addition to those reprogrammed funds, the Secretary of Health and Human Services announced last week that she would use her transfer authority to provide $47 million in additional funding to BARDA to ensure that vaccine development work is not delayed. BARDA anticipates obligating this additional funding by the end of the fiscal year. Even with this additional funding, BARDA will have significant unmet needs next fiscal year.
Advancing the development of Zika diagnostics is part of BARDA’s integrated portfolio for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.