Post by icemandios on Sept 20, 2021 12:48:59 GMT
OraSure Receives $205 Million Procurement Contract for InteliSwab™ from the Defense Logistics Agency to Supply Over-the-Counter (OTC) Kits as Part of National Pandemic Response
BETHLEHEM, Pa., Sept. 20, 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 the Defense Logistics Agency has awarded the Company a procurement contract for its InteliSwab™ COVID-19 Rapid Test for over-the-counter use, which the Defense Logistics Agency estimated to have a value of $205 million. Under the terms of the contract, OraSure will provide its InteliSwab™ COVID-19 Rapid Test to up to 25,000 sites throughout the United States and the tests will be funded by the U.S. federal government. The contract will run from October 2021 through September 2022.
“We are exceptionally proud to work with the Defense Logistics Agency and the U.S. federal government to be part of the nation’s pandemic response. We strongly believe testing will play a critical role in controlling the recent outbreak of the Delta variant and help to prevent future outbreaks. We believe widespread testing will allow Americans to return to work and school safely, as well as save lives and livelihoods,” said OraSure President and CEO Stephen Tang, Ph.D. “InteliSwab™ is uniquely suited to fulfill this mission as it was designed to be one of the simplest rapid antigen tests. Its intuitive nature makes it ideal for use in underserved communities and consumer testing settings throughout the U.S.”
InteliSwab™ is a simple “swab, swirl, see” test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed. It has three Emergency Use Authorizations from the Food and Drug Administration for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.
As the Company ramps to meet the requirements in this contract, it anticipates having significant incremental manufacturing and operating expenses in the second half of fiscal year 2021. Additionally, given the volume ramp implied in the contract, the Company expects the preponderance of revenue associated with the contract to come in calendar year 2022.
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 No. 75A50120C00061.
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 .
BETHLEHEM, Pa., Sept. 20, 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 the Defense Logistics Agency has awarded the Company a procurement contract for its InteliSwab™ COVID-19 Rapid Test for over-the-counter use, which the Defense Logistics Agency estimated to have a value of $205 million. Under the terms of the contract, OraSure will provide its InteliSwab™ COVID-19 Rapid Test to up to 25,000 sites throughout the United States and the tests will be funded by the U.S. federal government. The contract will run from October 2021 through September 2022.
“We are exceptionally proud to work with the Defense Logistics Agency and the U.S. federal government to be part of the nation’s pandemic response. We strongly believe testing will play a critical role in controlling the recent outbreak of the Delta variant and help to prevent future outbreaks. We believe widespread testing will allow Americans to return to work and school safely, as well as save lives and livelihoods,” said OraSure President and CEO Stephen Tang, Ph.D. “InteliSwab™ is uniquely suited to fulfill this mission as it was designed to be one of the simplest rapid antigen tests. Its intuitive nature makes it ideal for use in underserved communities and consumer testing settings throughout the U.S.”
InteliSwab™ is a simple “swab, swirl, see” test that uses an integrated swab to self-collect a sample from the lower nostrils. The result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed. It has three Emergency Use Authorizations from the Food and Drug Administration for professional point-of-care use, prescription (Rx) home use, and over-the-counter (OTC) use.
As the Company ramps to meet the requirements in this contract, it anticipates having significant incremental manufacturing and operating expenses in the second half of fiscal year 2021. Additionally, given the volume ramp implied in the contract, the Company expects the preponderance of revenue associated with the contract to come in calendar year 2022.
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 No. 75A50120C00061.
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 .