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OraSure Technologies Submits COVID-19 Rapid Antigen Prescription Home Self-Test and Professional Test to FDA for Emergency Use Authorization
Tests designed to detect active COVID-19 infection with a simple, easy-to-use workflow BETHLEHEM, Pa., March 30, 2021 (GLOBE NEWSWIRE) -- OraSure
About this update from Orasure Technologies, Inc.
[{"type":"text","content":"Tests designed to detect active COVID-19 infection with a simple, easy-to-use workflow\nBETHLEHEM, Pa., March 30, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its COVID-19 rapid antigen test for both Prescription Home Use, and Professional Use in point of care (POC) settings. These lateral flow, rapid diagnostic tests are designed to detect active COVID-19 infection with a simple, easy-to-use workflow, using samples self-collected from the lower nostrils. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution. No instrumentation, batteries, smart phone or laboratory analysis is needed to read the result, which appears on the test stick a short time later. “We believe our rapid antigen tests will be well received in the market thanks to their simplicity and ease of use. We also have the proven experience and capabilities to manufacture at scale to meet demand. With the race between vaccines and variants ongoing, testing will continue to play a crucial role in reopening workplaces, schools and other places where people gather,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies. “I’m delighted that we were able to accelerate the submission of the Prescription Home Self-Test. At-home testing will make it easier for individuals to safely and quickly know if they are infectious, and self-isolate to minimize transmission.” Subject to receipt of Emergency Use Authorization, the Company intends to market a COVID-19 Prescription Home Self-Test and a Professional Test for use in POC settings. With a simple design and straightforward workflow, OraSure’s tests are well suited for use by individuals at home, as well as by health care providers, employers, pharmacies, universities, and deployment into underserved communities when prescribed by a healthcare provider. ManufacturingOraSure has started manufacturing the COVID-19 rapid antigen test in parallel with EUA submission. The Company has well-established manufacturing capabilities, having produced over 80 million rapid HIV, HCV and Ebola tests. OraSure is in the midst of a manufacturing capacity expansion that will bring annual capacity for its rapid tests from 55 mill...