OraSure Technologies Inc. in Bethlehem today announced it was awarded a three-year contract for up to $10.4 million in funding from the U.S. to advance clinical development of a rapid antigen test for Ebola – the rare and deadly African-originated disease which last year made its way to the United States. The test could be crucial in containing Ebola outbreaks.
The funding comes from the U.S. Department of Health and Human Services and the Biomedical Advanced Research and Development Authority and is for Orasure’s OraQuick Ebola Rapid Antigen Test. The contract includes an initial commitment of $1.8 million and options for up to an additional $8.6 million to fund clinical and regulatory activities.
“We believe that the availability of an accurate and simple rapid Ebola antigen test will be critical to containing and controlling current and future Ebola outbreaks,” Douglas Michels, president and CEO of OraSure Technologies, said in a press release.
Earlier this year, OraSure announced it had completed the design of a prototype device for the Ebola test. And during the first quarter of 2015, the company recognized revenues from the initial sales of the product to the Centers for Disease Control and Prevention for investigational use in Africa.
The data generated from this field testing, along with other clinical and nonclinical studies being performed, are expected to be used in an application to obtain emergency-use authorization from the U.S. Food and Drug Administration during the next several months.
The rapid test can be used in a doctor’s office, hospital, clinic or field setting and can provide results within 20 minutes. OraSure continues to focus its efforts on securing sustainable product purchase commitments from both government and nongovernment sources.
OraSure’s OraQuick technology platform is the same technology used in the company’s rapid test kits for the human immunodeficiency virus and Hepatitis-C virus. OraSure developed the first FDA-approved rapid test for HIV and the first and only FDA-approved HIV test for in-home use by consumers.
OraSure Technologies and its two subsidiaries and 320 employees develop, manufacture and distribute oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions.