Post by icemandios on Sept 23, 2021 12:43:14 GMT
OraSure to Receive up to $13.6 Million from Biomedical Advanced Research Development Authority to Support InteliSwab™ COVID-19 Rapid Test 510(k) Clearance and CLIA Waiver
BETHLEHEM, Pa., Sept. 23, 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 Biomedical Advanced Research Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSure’s InteliSwab™ COVID-19 rapid test from the Food and Drug Administration (FDA).
InteliSwab™ is a simple “swab, swirl, and 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.
“Rapid COVID-19 antigen tests can help to facilitate containment and minimize outbreaks by detecting those individuals infected with COVID-19. Testing with InteliSwab™ is expected to be an important component of governments’, private industries’ and communities’ response to the COVID-19 pandemic, along with vaccination and protection,” said OraSure President and CEO, Stephen Tang, Ph.D. “Once received, this full regulatory clearance will help ensure continued availability of the InteliSwab™ COVID-19 Rapid Test long-term.”
The InteliSwab™ COVID-19 Rapid Test is authorized for emergency use for the duration of the public health declaration. With FDA 510(k) clearance, InteliSwab™ can continue to be marketed without a public health emergency declaration from the Secretary of the Department of Health and Human Services (HHS). To date, there are no COVID-19 rapid antigen tests with 510(k) clearance and the requirements for 510(k) clearance are expected to be more stringent than the requirements for EUA.
Following 510(k) clearance, the Company will pursue Clinical Laboratory Improvement Amendments (CLIA) waiver for InteliSwab™, ensuring the test can continue to be performed by an untrained user outside of the laboratory setting.
This project has been funded in whole or in part with federal funds from BARDA, part of the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response under contract number 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 the 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. 23, 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 Biomedical Advanced Research Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), will provide up to $13.6 million in funding for the Company to obtain 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for OraSure’s InteliSwab™ COVID-19 rapid test from the Food and Drug Administration (FDA).
InteliSwab™ is a simple “swab, swirl, and 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.
“Rapid COVID-19 antigen tests can help to facilitate containment and minimize outbreaks by detecting those individuals infected with COVID-19. Testing with InteliSwab™ is expected to be an important component of governments’, private industries’ and communities’ response to the COVID-19 pandemic, along with vaccination and protection,” said OraSure President and CEO, Stephen Tang, Ph.D. “Once received, this full regulatory clearance will help ensure continued availability of the InteliSwab™ COVID-19 Rapid Test long-term.”
The InteliSwab™ COVID-19 Rapid Test is authorized for emergency use for the duration of the public health declaration. With FDA 510(k) clearance, InteliSwab™ can continue to be marketed without a public health emergency declaration from the Secretary of the Department of Health and Human Services (HHS). To date, there are no COVID-19 rapid antigen tests with 510(k) clearance and the requirements for 510(k) clearance are expected to be more stringent than the requirements for EUA.
Following 510(k) clearance, the Company will pursue Clinical Laboratory Improvement Amendments (CLIA) waiver for InteliSwab™, ensuring the test can continue to be performed by an untrained user outside of the laboratory setting.
This project has been funded in whole or in part with federal funds from BARDA, part of the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response under contract number 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 the 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 .