OraSure Gets Approval for Covid-19 Tests on Children 2 to 14 Years Old
31 1월 2022 - 9:53PM
Dow Jones News
By Chris Wack
OraSure Technologies Inc. said its InteliSwab Covid-19 rapid
tests have been authorized by the U.S. Food and Drug Administration
for use in children ages 2 to 14.
The company said its InteliSwab tests were 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% positive percent
agreement for individuals ages 2 and up and 98% negative percent
agreement, the company said.
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% 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, the company
said.
The company also said it launched a new reporting app,
InteliSwab Connect, which will allow people to easily report their
test results to public-health authorities. It can also help
employers track prevalence in the workplace.
OraSure shares were up 3% to $8.86 in premarket trading.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 31, 2022 07:38 ET (12:38 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
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