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 U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
The test being developed by InBios International, Inc. of Seattle, Washington, may be able to return results in about four hours and could be used in commercial and health care facility laboratories. The diagnostic is known as a serological test, which detects a Zika virus-specific Immunoglobulin M, or IgM, which are antibodies produced by the body’s immune response to the virus. These antibodies can be detected approximately one week after infection and persist in blood for up to three months.
Currently, the only serological test available to detect Zika in people with recent infections is a test that was developed by the Centers for Disease Control and Prevention (CDC) and is being used under an emergency use authorization issued by the U.S. Food and Drug Administration (FDA). The CDC-developed test requires two to three 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.
“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,” said Assistant Secretary for Preparedness and Response Dr. Nicole Lurie. “Doctors and patients need Zika test results quickly so that health care providers can offer appropriate guidance and treatment to their patients, particularly pregnant women and their partners.”
Continued development of InBios’ will be funded under a two-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 and up to a total of approximately $9.5 million.
While advanced development work including manufacturing improvements are underway, the company could apply to the FDA to allow the test to be used under emergency use authorization prior to FDA’s full approval or market authorization of 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,” said BARDA Acting Director Dr. Richard Hatchett. “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.”
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. For this reason, many people might not realize they have been infected. However, Zika virus infection can cause Guillain Barre Sydrome or 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 assure the availability of blood samples developers need to test the accuracy of Zika diagnostics. The division also is working with federal partners on vaccine development to protect against Zika virus infections. With this award, ASPR/BARDA 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 health care coalitions, hospitals, providers and public health departments to ensure they are monitoring for babies born with Zika and can care for babies born with Zika. ASPR also is supporting state and federal public health emergency planning through a GIS-based platform called Geohealth, and is working with industry partners to monitor the supply chain of mosquito control products. ASPR also oversees the Medical Reserve Corps; more than 100 Medical Reserve Corps volunteers are supporting public health education efforts for Zika in Puerto Rico.
ASPR leads HHS efforts 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. Advancing the development of 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.
To learn more about Zika, visit www.cdc.gov/zika. To learn more about preparing for and responding to public health emergencies, from new infectious diseases to natural disasters and bioterrorism, visit the HHS public health emergency website, www.phe.gov.