FDA issues diagnostic Emergency Use Authorization to Hologic, LabCorp and Thermo Fisher
The FDA issued Emergency Use Authorizations (EUAs) to Hologic for its Panther Fusion SARS-COV-2 assay and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.
LabCorp began offering testing services last week. The FDA also issued an EUA to Thermo Fisher for its TaqPath COVID-19 Combo Kit.
“Our device center has been in continual contact with the medical device community, in particular diagnostic developers, since January, providing technical assistance to test developers to help facilitate the availability and distribution of tests so that health care professionals can accurately detect the COVID-19 virus,” said FDA Commissioner Stephen M. Hahn, MD.
He also said that more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process, while more than 40 labs said they are testing or plan to begin testing with laboratory developed tests (LDTs).
