Post by icemandios on Oct 4, 2021 12:56:34 GMT
OraSure Awarded $109 Million Contract from U.S. Department of Defense to Ramp Manufacturing of InteliSwab™ COVID-19 Rapid Test
Agreement Ensures OraSure Will Have Sufficient Capacity to Meet Market Need for Rapid Antigen Tests and Ensure Future Preparedness
BETHLEHEM, Pa., Oct. 04, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that it has been awarded a $109 million contract from the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), to build additional manufacturing capacity in the United States for InteliSwab™ COVID-19 rapid tests as part of the nation’s pandemic preparedness plan.
InteliSwab is a remarkably simple test that rapidly detects active COVID-19 infection. It was granted three Emergency Use Authorizations (EUAs) by the Food and Drug Administration (FDA) in June for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.
“The U.S. government’s selection of OraSure’s InteliSwab™ rapid test for this national pandemic preparedness effort is a great honor and ensures we can make the necessary investments to scale manufacturing in order to support our nation’s pandemic response,” said OraSure President and CEO Stephen Tang, Ph.D. “This test will play a key role in ensuring our nation is prepared to continue the fight against this, and possible future pandemics and potential resurgences in disease activity.”
The federal funding will expand OraSure’s production capacity by 100 million tests annually, by March 2024. An existing OraSure location in Bethlehem, Pennsylvania, will be retrofitted to accommodate increased manufacturing and an additional new facility will be added in another U.S. location to be determined. In addition to this contract, OraSure also has internally funded expansion plans to achieve 120 million tests annually by the second quarter of 2022.
A recent study by the National Institutes of Health shows rapid antigen tests perform on par with lab PCR tests when testing at least twice per week with the antigen test. 1
“Home testing options prevent the risk of further spread of the virus, and minimize the burden on the individual, making them an ideal cornerstone of any national pandemic preparedness strategy,” Tang said. “As a company we stand ready to aid in the government’s efforts to allow individuals to return to work and school safely. Beyond that, this funding will allow OraSure to respond to future public health crises.”
Multiple government agencies, including the DOD and HHS are working to address COVID-19 testing needs. Development of the InteliSwab™ COVID-19 Rapid Test 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, Division of Research, Innovation and Ventures under contract number 75A50120C00061, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab™ COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.
1 Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection , The Journal of Infectious Diseases, 2021; jiab337, doi.org/10.1093/infdis/jiab337
About InteliSwab ™
OraSure has received Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils.
InteliSwab™’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as Swab, Swirl, and See.
This product has not been FDA cleared or approved; but authorized by the FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
OraSure’s Response to COVID-19
OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid antigen self testing and molecular sample collection for PCR-based tests. The Company’s portfolio of COVID-19 tests and collection kits all feature easy, convenient, pain-free self-collection, and help increase access to testing, while alleviating the burden on the healthcare system and minimizing exposure risks.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .
Agreement Ensures OraSure Will Have Sufficient Capacity to Meet Market Need for Rapid Antigen Tests and Ensure Future Preparedness
BETHLEHEM, Pa., Oct. 04, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that it has been awarded a $109 million contract from the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), to build additional manufacturing capacity in the United States for InteliSwab™ COVID-19 rapid tests as part of the nation’s pandemic preparedness plan.
InteliSwab is a remarkably simple test that rapidly detects active COVID-19 infection. It was granted three Emergency Use Authorizations (EUAs) by the Food and Drug Administration (FDA) in June for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.
“The U.S. government’s selection of OraSure’s InteliSwab™ rapid test for this national pandemic preparedness effort is a great honor and ensures we can make the necessary investments to scale manufacturing in order to support our nation’s pandemic response,” said OraSure President and CEO Stephen Tang, Ph.D. “This test will play a key role in ensuring our nation is prepared to continue the fight against this, and possible future pandemics and potential resurgences in disease activity.”
The federal funding will expand OraSure’s production capacity by 100 million tests annually, by March 2024. An existing OraSure location in Bethlehem, Pennsylvania, will be retrofitted to accommodate increased manufacturing and an additional new facility will be added in another U.S. location to be determined. In addition to this contract, OraSure also has internally funded expansion plans to achieve 120 million tests annually by the second quarter of 2022.
A recent study by the National Institutes of Health shows rapid antigen tests perform on par with lab PCR tests when testing at least twice per week with the antigen test. 1
“Home testing options prevent the risk of further spread of the virus, and minimize the burden on the individual, making them an ideal cornerstone of any national pandemic preparedness strategy,” Tang said. “As a company we stand ready to aid in the government’s efforts to allow individuals to return to work and school safely. Beyond that, this funding will allow OraSure to respond to future public health crises.”
Multiple government agencies, including the DOD and HHS are working to address COVID-19 testing needs. Development of the InteliSwab™ COVID-19 Rapid Test 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, Division of Research, Innovation and Ventures under contract number 75A50120C00061, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab™ COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.
1 Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection , The Journal of Infectious Diseases, 2021; jiab337, doi.org/10.1093/infdis/jiab337
About InteliSwab ™
OraSure has received Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils.
InteliSwab™’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as Swab, Swirl, and See.
This product has not been FDA cleared or approved; but authorized by the FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
OraSure’s Response to COVID-19
OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid antigen self testing and molecular sample collection for PCR-based tests. The Company’s portfolio of COVID-19 tests and collection kits all feature easy, convenient, pain-free self-collection, and help increase access to testing, while alleviating the burden on the healthcare system and minimizing exposure risks.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com .