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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
About this update from Orasure Technologies, Inc.
[{"type":"text","content":"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 thei...