Applied DNA Applies for FDA Emergency-Use Authorization for At-Home Covid-19 Test
January 21 2022 - 11:07AM
Dow Jones News
By Kimberly Chin
Applied DNA Sciences Inc. said Friday it has submitted an
emergency-use authorization request for its Covid-19 assay and
at-home Covid-19 test.
The Linea 2.0 Assay is an RT-PCR assay that targets the E and N
genes of SARS-CoV-2. The Linea Unsupervised At-Home Sample
Collection Kit allows people to easily self-administer a nasal swab
sample that can then be mailed directly to Applied DNA Clinical
Labs LLC. Results typically return within 24 to 48 hours upon the
sample's arrival, the company said.
The test is capable of detecting all known Covid-19 variants,
the company said.
The company said the approval could open a path for it to expand
its fully integrated Covid-19 testing platform nationally,
particularly in enterprises and educational institutions. The
testing platform provides Covid-19 diagnostic testing and other
services.
Write to Kimberly Chin at kimberly.chin@wsj.com
(END) Dow Jones Newswires
January 21, 2022 10:52 ET (15:52 GMT)
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