Business
OraSure Technologies Receives Three Emergency Use Authorizations for its COVID-19 Rapid Antigen Tests for Non-Prescription (OTC), Professional and Prescription Use
Branded as InteliSwab™, the easy-to-use diagnostic tests rapidly detect active COVID-19 infection BETHLEHEM, Pa., June 07, 2021 (GLOBE NEWSWIRE) -- OraSure
About this update from Orasure Technologies, Inc.
[{"type":"text","content":"Branded as InteliSwab™, the easy-to-use diagnostic tests rapidly detect active COVID-19 infection\nBETHLEHEM, Pa., June 07, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which the Company is branding as InteliSwab™. These tests detect active COVID-19 infection. 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 the InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. OraSure will market three versions of InteliSwab™: InteliSwab™ COVID-19 Rapid Test: The OTC home test for use without a prescription in individuals 15 years or older (with or without symptoms) when tested twice over two or three days with at least 24 and no more than 36 hours between tests.InteliSwab™ COVID-19 Rapid Test Pro: The Professional Test, which is packaged in bulk configurations, is authorized for use at the point of care in healthcare settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, for individuals 15 years or older who are suspected of COVID-19 by their healthcare provider within 7 days of symptom onset or for individuals without symptoms when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.InteliSwab™ COVID-19 Rapid Test Rx: The prescription home test is authorized for prescription home use with self-collection (unobserved) of anterior nasal samples from individuals 18 years or older or adult collected samples from individuals age 15 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven (7) days of symptom onset. The unique design of InteliSwab™ incorporates a built-in swab that is fully integrated into the test stick, simplifying the entire testing process. Use of this integrated swab also helps ensure supply continuity, as InteliSwab™ does not require sourcing scarce nasal swabs. Testing with InteliSwab™ is simple: users swab their lower nostrils with the test stick, swirl it in a pre-measured solution, and...