A blood test that may reduce from days to hours the time needed to diagnose patients with recent Zika virus infections will receive advanced development support from the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
The test being developed by InBios International, Seattle, Wash, may be able to return results in about 4 hours and could be used in commercial and healthcare facility laboratories. The serological test detects Zika virus-specific immunoglobulin M (IgM), which are antibodies produced by the body’s immune response to the virus. The antibodies can be detected approximately 1 week after infection and persist in blood for up to 3 months.
The only serological test currently available to detect Zika in people with recent infections is a test that was developed by the US Centers for Disease Control and Prevention (CDC), which is being used under an emergency use authorization issued by FDA. The CDC-developed test requires 2 to 3 days for results and must be conducted in qualified laboratories designated by CDC.
Providing a faster, easy-to-run, commercially available test to clinical laboratories would increase Zika testing capacity significantly nationwide.
FDA has also granted emergency use authorizations for molecular diagnostics to detect Zika virus under development by Altona Diagnostics, CDC, DiaSorin Molecular Diagnostics (formerly Focus Diagnostics), Hologic, Luminex, Siemens Healthineers, and Viracor-IBT Laboratories.
Nicole Lurie, MD, MSPH, US Department of Health and Human Services.
“The situation in Puerto Rico, the increasing number of Zika cases in the continental United States, and the potential for local transmission are of great concern,” says assistant secretary for preparedness and response Nicole Lurie, MD, MSPH. “Doctors and patients need Zika test results quickly so that healthcare providers can offer appropriate guidance and treatment to their patients, particularly pregnant women and their partners.”
Continued development of InBios’ diagnostic will be funded under a 2-year, $5.1 million contract with ASPR’s biomedical advanced research and development authority (BARDA). This funding will support the refinement of the test’s design, manufacturing preparations, and clinical studies, all of which are necessary for the company to receive approval or marketing authorization from FDA. The agreement can be extended to fund additional work through 2021, up to a total of approximately $9.5 million.
While advanced development work is under way, including manufacturing improvements, the company could apply to FDA to allow the test to be used under emergency use authorization, prior to the agency’s full approval or market authorization for the test.
“Most people with Zika virus infections do not have symptoms, which makes diagnostics critical in identifying cases, treating patients, and protecting public health,” says BARDA acting director Richard J. Hatchett, MD. “We are collaborating with other federal and industry partners to identify additional promising candidates for development so that diagnostics and other medical products needed in this public health crisis become available as quickly as possible.”
Richard J. Hatchett, MD, US Department of Health and Human Services.
The most common symptoms of Zika are fever, rash, joint pain, and conjunctivitis, or red eyes. The illness is usually mild, with symptoms lasting for several days to a week. People typically do not get sick enough to go to the hospital. For this reason, many people might not realize they have been infected. However, Zika virus infection can cause Guillain-Barré syndrome, and during pregnancy can cause a serious birth defect called microcephaly.
In addition to the InBios diagnostic, BARDA is supporting development of tests that screen for Zika virus in the blood supply, and is helping to ensure the availability of the blood samples that developers need to test the accuracy of Zika diagnostics. The division is also working with federal partners on vaccine development to protect against Zika virus infections. Including its award to InBios, ASPR has obligated $37.2 million of HHS reprogrammed Ebola funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.
These product development programs are part of broader efforts by HHS agencies to respond to the Zika epidemic. ASPR and CDC are providing guidance to healthcare coalitions, hospitals, providers, and public health departments to ensure they are monitoring and can care for babies born with Zika. ASPR is also supporting state and federal public health emergency planning through a geographic information system-based platform called Geohealth, and is working with industry partners to monitor the supply chain for mosquito control products.
For additional information, visit the HHS public health emergency website.
