Post by icemandios on Jan 31, 2022 13:27:17 GMT
InteliSwab® COVID-19 Rapid Tests Receive U.S. FDA Authorization for Pediatric Use and Company Launches New InteliSwab® Connect Reporting App
Data Demonstrates InteliSwab ® is Accurate, Easy to Use, and Well Accepted by Children
BETHLEHEM, Pa., Jan. 31, 2022 (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 its InteliSwab ® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab ® was previously authorized for use in adults and in children 15 to 17 when administered by an adult.
As part of its submission to the FDA for this label expansion, the Company conducted studies to evaluate the performance of the test in a pediatric population, as well as studies to evaluate usability and tolerability by children. From a combined performance perspective, InteliSwab ® was shown to have 85 percent positive percent agreement (PPA) for individuals ages 2 and up and 98 percent negative percent agreement (NPA). The overall accuracy of the InteliSwab ® test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the Company’s clinical studies in adults. OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96 percent of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range.
“Helping our children stay in school and get back to normal is crucial to their wellbeing and continued development,” said OraSure President and CEO Stephen Tang, Ph.D. “Fast, frequent testing is a key component to making this happen and we are delighted that our InteliSwab ® test can now be used for children. The test is accurate and easy to use, so caregivers can feel confident when they choose to use this test on a child.”
In addition, the Company also announced today the launch of a new reporting app, InteliSwab ® Connect, which will allow people to easily report their test results to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace. The app will be available on the Apple App Store and via Google Play.
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 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. 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 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 HHS; the Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract numbers 75A50120C00061 and 75A50121C00078, 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). The manufacturing 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 .
Data Demonstrates InteliSwab ® is Accurate, Easy to Use, and Well Accepted by Children
BETHLEHEM, Pa., Jan. 31, 2022 (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 its InteliSwab ® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab ® was previously authorized for use in adults and in children 15 to 17 when administered by an adult.
As part of its submission to the FDA for this label expansion, the Company conducted studies to evaluate the performance of the test in a pediatric population, as well as studies to evaluate usability and tolerability by children. From a combined performance perspective, InteliSwab ® was shown to have 85 percent positive percent agreement (PPA) for individuals ages 2 and up and 98 percent negative percent agreement (NPA). The overall accuracy of the InteliSwab ® test including a pediatric population is 93 percent, demonstrating similar accuracy when compared to the Company’s clinical studies in adults. OraSure also evaluated the usability and acceptability of the test in children. In the usability study, parents were able to use the test on children error free 96 percent of the time, demonstrating the exceptional ease of use of the test. The test was also well accepted by children across a broad age range.
“Helping our children stay in school and get back to normal is crucial to their wellbeing and continued development,” said OraSure President and CEO Stephen Tang, Ph.D. “Fast, frequent testing is a key component to making this happen and we are delighted that our InteliSwab ® test can now be used for children. The test is accurate and easy to use, so caregivers can feel confident when they choose to use this test on a child.”
In addition, the Company also announced today the launch of a new reporting app, InteliSwab ® Connect, which will allow people to easily report their test results to public health authorities, helping communities with COVID-19 prevalence surveillance efforts. It can also help employers track prevalence in the workplace. The app will be available on the Apple App Store and via Google Play.
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 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. 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 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 HHS; the Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract numbers 75A50120C00061 and 75A50121C00078, 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). The manufacturing 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 .