OraQuick ebola

The OraQuick ebola rapid antigen test by OraSure Technologies.

The US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract for up to $10.4 million to OraSure Technologies Inc, Bethlehem, Pa, for development activities related to the company’s OraQuick ebola rapid antigen test.

OraSure is a leader in point-of-care diagnostic tests and specimen collection devices. The company’s rapid ebola test uses its proven OraQuick technology, which is the same platform used for the company’s rapid HIV and HCV test kits.

BARDA’s 3-year, multiphased contract includes an initial commitment of $1.8 million and options for up to an additional $8.6 million to fund certain 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,” says Douglas A. Michels, president and CEO of OraSure Technologies. “We are grateful to BARDA for making this funding available, as it will enable us to complete key clinical activities and obtain important regulatory approvals for this product.”

OraSure develops, manufactures, and distributes point-of-care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick platform; oral fluid sample collection, stabilization, and preparation products for molecular diagnostic applications; and oral fluid laboratory tests for detecting various drugs of abuse.


Douglas A. Michels, OraSure Technologies.

Earlier in the year, OraSure announced that it had completed the design of a prototype device that appears to deliver analytical performance similar to laboratory PCR tests when evaluated on stored samples from infected patients. During the first quarter of 2015, the company recognized revenues from initial sales of that product to the Centers for Disease Control and Prevention for investigational use in Africa.

The data generated from the African field testing, along with data from other clinical and nonclinical studies being performed, are expected to be used during the next several months in an application to obtain FDA emergency use authorization for the ebola test. The company continues to focus its efforts on securing sustainable product purchase commitments from both government and nongovernment sources.

OraSure has a successful track record for developing and commercializing point-of-care tests that address critical disease states. The company has developed the only FDA-approved rapid test for hepatitis C, the OraQuick HCV rapid antibody test; and the first FDA-approved rapid test for HIV, the OraQuick Advance HIV 1/2 antibody test. The company has also developed the first HIV test approved by FDA for use by consumers, the OraQuick In-Home HIV test.

For more information, visit OraSure Technologies.