Danaher Unit's SARS-CoV-2 IgG Antibody Test Gets FDA Emergency Use OK
June 29 2020 - 8:46AM
Dow Jones News
By Colin Kellaher
Danaher Corp.'s Beckman Coulter unit on Monday said its Access
SARS-CoV-2 IgG assay received U.S. Food & Drug Administration
emergency-use authorization.
Beckman Coulter said it has already shipped tests to more than
400 hospitals, clinics and diagnostics laboratories in the U.S.,
and that it has begun distribution of the new antibody tests
globally.
The company said it is able to deliver more than 30 million
tests a month.
Beckman Coulter said the test, which detects IgG antibodies
directed to the receptor binding domain of the spike protein of the
novel coronavirus, has shown 100% positive percent agreement and
99.6% negative percent agreement, significantly reducing the risk
for false positives.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 29, 2020 08:31 ET (12:31 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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