OraSure Technologies, Inc., a leader in point of care diagnostic tests and specimen collection devices, announced that it has been awarded a contract for up to $10.4 million in total funding from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response's Biomedical Advanced Research and Development Authority (BARDA) related to the Company's OraQuick® Ebola Rapid Antigen Test. The three-year, multi-phased 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.
The Company's rapid Ebola test utilizes the OraQuick® technology platform which is the same proven technology used in the Company's rapid HIV and HCV test kits.
"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," said Douglas A. Michels, President and Chief Executive Officer 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."
Earlier in the year, the Company 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 also recognized revenues from the initial sales of this 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 non-clinical studies being performed, is expected to be used in an application to obtain Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) during the next several months. The Company continues to focus its efforts on securing sustainable product purchase commitments from both government and non-government sources.
OraSure has a highly 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 and only HIV test approved by the FDA for use by consumers, the OraQuick® In-Home HIV Test.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500009C.
The Company's rapid Ebola test utilizes the OraQuick® technology platform which is the same proven technology used in the Company's rapid HIV and HCV test kits.
"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," said Douglas A. Michels, President and Chief Executive Officer 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."
Earlier in the year, the Company 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 also recognized revenues from the initial sales of this 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 non-clinical studies being performed, is expected to be used in an application to obtain Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) during the next several months. The Company continues to focus its efforts on securing sustainable product purchase commitments from both government and non-government sources.
OraSure has a highly 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 and only HIV test approved by the FDA for use by consumers, the OraQuick® In-Home HIV Test.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500009C.