OSUR OraSure Technologies Inc

By Michael Dabaie

OraSure Technologies Inc. shares rose 7% to $11.82 in premarket trading after the company said the U.S. Food and Drug Administration authorized its InteliSwab Covid-19 rapid tests for over-the-counter single-use, at-home testing for symptomatic people and accepted data for Delta variant detection.

OraSure said the FDA amended the emergency use authorization for the Covid-19 rapid tests 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, 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.

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.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

November 02, 2021 09:21 ET (13:21 GMT)

OraSure Technologies (NASDAQ:OSUR)
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