We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as ...

-- Company to Produce at Least One Million Tests a Week to Run on More than 1,000 Panther Instruments Installed in All 50 States -- -- Significant Assay Manufacturing Capacity Plus Large Installed ...

Hologic, Inc. HOLX recently announced the receipt of the FDA’s Emergency Use Authorization (EUA) for its Aptima SARS-CoV-2 assay, which can be used to detect SARS-CoV-2, the virus causing coronavirus.

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) has obtained a CE Mark for the use of saliva samples with the Aptima® SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a ...