On Monday, the U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing Emergency Use Authorizations (EUAs) to: Hologic...
Today, the U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted...
The U.S. Food and Drug Administration today permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.).
This is the first...
Hologic, Inc. announced this week that its Panther Fusion® MRSA assay has received CE-mark in Europe. This assay, the latest in a growing menu of Panther Fusion® and Aptima® assays, brings full automation,...
Today, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response announced a $4.1 million agreement with Hologic, Inc. of Marlborough, Massachusetts,...
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