Danaher Unit's SARS-CoV-2 IgM Antibody Test Gets FDA Emergency Use OK
October 09 2020 - 8:45AM
Dow Jones News
By Colin Kellaher
Danaher Corp.'s Beckman Coulter unit on Friday said its Access
SARS-CoV-2 IgM assay received U.S. Food & Drug Administration
emergency-use authorization.
Beckman Coulter said the test, which detects antibodies that
recognize the receptor binding domain of the spike protein that the
SARS-CoV-2 virus uses to enter the human host cells, demonstrates
99.9% specificity and 98.3% sensitivity.
Beckman Coulter said the test is part of a suite of diagnostic
solutions it is developing in response to the coronavirus
pandemic.
The company previously received FDA emergency-use authorization
for its Access SARS-CoV-2 IgG assay and its interleukin 6 assay,
which can be used to assist in identifying severe inflammatory
response in patients with confirmed Covid-19 illness.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 09, 2020 08:30 ET (12:30 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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