On August 23, 2016, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)www.phe.gov announced a $7 million contract with Orasure Technologies Inc. of Bethlehem Pennsylvania www.orasure.com to further develop a Zika virus test. Orasure’s test is a lateral flow serological test which is similar to a home pregnancy test but uses a few drops of blood instead of urine.
A few days later on August 25, 2016, HHS announced ASPR has provided funding to develop test to provide a Zika diagnosis for patients in less than 30 minutes in doctors and other healthcare provider’s offices.
It is hopeful that the lateral-flow serological test being developed by Chembio Diagnostic Systems of Medford NY http://Chembio.com will be able to identify the antibodies in the human immune system that respond to the Zika virus.
Biomedical Advanced Research and Development Authority (BARDA) www.phe.gov/barda within ASPR will provide Chembio $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. This testing is necessary for Chembio to do in order to apply for approval from FDA to commercially market the product.
HHS is funding other tests being developed by DiaSorin Group www.diasorin by providing $2.6 million and InBios www.inbios.com with funding for $5.1 million. The companies are designing tests for use in commercial and healthcare facility laboratories. A molecular test is also being funded for $4.1 million to be developed by Hologic www.hologic.com for use in blood banks.
As of August 2016, in response to the Zika virus outbreak, HHS agencies have obligated more than $248 million in reprogrammed funds. BARDA received $85 million of the reprogrammed funds and so far has obligated more than $50 million of the funds to develop vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.