Post by icemandios on Nov 2, 2021 12:53:36 GMT
U.S. FDA Authorizes InteliSwab™ COVID-19 Rapid Tests for OTC Single-Use, At-Home Testing for Symptomatic People and Accepts Data for Delta Variant Detection
BETHLEHEM, Pa., Nov. 02, 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 EUA for its InteliSwab™ COVID-19 rapid tests has been amended by the U.S. Food and Drug Administration (FDA) to only require one test for individuals with symptoms of COVID-19. Previously, the at-home test was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.
In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories which showed detection of all variants of concern, including the Delta variant. The FDA reviewed the data submitted by OraSure regarding the detection of the SARS-CoV-2 Delta variant and indicated that the data was adequate, and that no further data is required.
“These studies in independent labs clearly show the InteliSwab™ tests detect variants, including the Delta variant that roared through the country late this summer, and this should give people extra confidence in the accuracy of InteliSwab™,” said OraSure President and CEO Stephen Tang, Ph.D. “Beyond that, the authorization of the InteliSwab™ COVID-19 Rapid Test to be used as a one-time, over-the-counter test for people with COVID-19 symptoms will help increase our nationwide availability of tests, ensuring people who want rapid tests have access to them.”
About InteliSwab™
OraSure has received Emergency Use Authorizations (EUA) from the 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. The FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the 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 end of 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 it has been authorized by the FDA under an EUA. The emergency use of 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.
Multiple government agencies, including the U.S. Department of Defense (DoD) and the U.S. Department of Health and Human Services (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 Biomedical Advanced Research and Development Authority’s Division of Research, Innovation and Ventures within HHS’ the Office of the Assistant Secretary for Preparedness and Response 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.
OraSure’s Response to COVID-19
OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid COVID-19 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., Nov. 02, 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 EUA for its InteliSwab™ COVID-19 rapid tests has been amended by the U.S. Food and Drug Administration (FDA) to only require one test for individuals with symptoms of COVID-19. Previously, the at-home test was authorized for over-the-counter use in people with or without symptoms when tested twice with at least 24 hours but not more than 36 hours between tests, which is called serial testing. Now, people with symptoms only need to test once; people without symptoms should still perform serial testing if they get a negative result on their first test.
In addition, OraSure conducted studies using live SARS-CoV-2 virus at independent laboratories which showed detection of all variants of concern, including the Delta variant. The FDA reviewed the data submitted by OraSure regarding the detection of the SARS-CoV-2 Delta variant and indicated that the data was adequate, and that no further data is required.
“These studies in independent labs clearly show the InteliSwab™ tests detect variants, including the Delta variant that roared through the country late this summer, and this should give people extra confidence in the accuracy of InteliSwab™,” said OraSure President and CEO Stephen Tang, Ph.D. “Beyond that, the authorization of the InteliSwab™ COVID-19 Rapid Test to be used as a one-time, over-the-counter test for people with COVID-19 symptoms will help increase our nationwide availability of tests, ensuring people who want rapid tests have access to them.”
About InteliSwab™
OraSure has received Emergency Use Authorizations (EUA) from the 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. The FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and the 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 end of 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 it has been authorized by the FDA under an EUA. The emergency use of 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.
Multiple government agencies, including the U.S. Department of Defense (DoD) and the U.S. Department of Health and Human Services (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 Biomedical Advanced Research and Development Authority’s Division of Research, Innovation and Ventures within HHS’ the Office of the Assistant Secretary for Preparedness and Response 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.
OraSure’s Response to COVID-19
OraSure is leveraging its expertise in infectious disease testing and molecular sample collection with EUAs for rapid COVID-19 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 .