The Company announced that the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) has exercised an option to provide $7.2 million in additional funding for the Company's OraQuick® Ebola Rapid Antigen Test. This funding will be used primarily for clinical and regulatory activities required to request U.S. Food and Drug Administration (FDA) 510(k) clearance for this product. This option is part of the $10.4 million funding contract (base plus options) between OraSure and BARDA that was previously announced in June 2015.
The Company also announced today that HHS' Centers for Disease Control and Prevention (CDC) will purchase approximately $1.5 million of the Company's OraQuick® Ebola Rapid Antigen Test. The CDC purchase is expected to be fulfilled by the end of 2015. CDC is purchasing the OraQuick® Ebola Rapid Antigen Tests for field testing in West Africa. This is the second such purchase of this product for field testing made by CDC.
"The populations affected by Ebola are large, and current testing methods severely limit testing capacity. As such, we believe that the OraQuick® Rapid Ebola Test will be an important tool in containing and controlling the Ebola outbreak," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are grateful to both the CDC and BARDA for their continued support."
The OraQuick® Ebola Rapid Antigen Test utilizes the same proven technology platform used in the Company's rapid HIV and HCV test kits. The OraQuick® Ebola Test received Emergency Use Authorization (EUA) from the FDA in July 2015 and is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results have to be read at 30 minutes. The test can be used at ambient temperatures (up to 40°C / 104°F), is easy to use with a simple visual read, and does not require instrumentation.
This project has been funded in whole or in part with Federal funds from BARDA, part of the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; under Contract No. HHSO100201500009C.
Critical reagents in the OraQuick® Ebola Rapid Antigen Test are being supplied by the Viral Hemorrhagic Fever Consortium (VHFC; www.vhfc.org) and the Biological Defense Research Directorate at the United States Navy Medical Research Center (NMRC). The VHFC reagents were developed with the support of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIH/NIAID"). VHFC members, Autoimmune Technologies LLC, and Zalgen Labs LLC manufacture the critical reagents.