HHS funds development of Zika diagnostic test for use in doctors’ offices

A test that could provide a Zika diagnosis for patients less than 30 minutes in doctors’ and other healthcare providers’ offices is moving forward with funding from the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

Chembio Diagnostic Systems, Inc. of Medford, New York, is developing a lateral-flow serological test to identify antibodies that the human immune system produces in response to Zika virus.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide $5.9 million over the next year for the product’s continued development, manufacturing preparations and a clinical trial to evaluate the sensitivity and specificity of the test, which are necessary to apply for approval from the U.S. Food and Drug Administration to commercially market the product. This contract could be extended for up to a total of three years and $13.2 million.

“Developing safe and effective diagnostic tests, vaccines, and blood screens are essential in curbing the spread of the Zika virus,” said Dr. Richard Hatchett, BARDA acting director. “We are working to move medical products through the development pipeline to reach the market as quickly as possible so that doctors and other healthcare providers have the information they need to guide clinical management.”

This test is the second point-of-care test ASPR is sponsoring to detect recent Zika virus infections. A lateral-flow test is similar to a home pregnancy test, but uses a single drop of blood instead of urine. Because they do not need to be sent to a laboratory for results, these tests help reduce long delays in getting test results.

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.

ASPR also is supporting advanced development of two laboratory diagnostic tests for the virus.

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 certain birth defects including a severe birth defect called microcephaly.

To respond to the Zika virus outbreak, HHS repurposed $374 million for domestic Zika response and preparedness activities. As of August, HHS agencies have obligated $259 million of these repurposed funds. ASPR’s BARDA received $85 million of these reprogrammed funds, and with today’s award, BARDA has obligated approximately $57 million of these reprogrammed funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologiesthrough private sector partners.

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.

ASPR leads HHS 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. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.