Coronavirus, COVID-19

FDA Issues Emergency Use Authorization for Hologic and LapCorp COVID-19 Tests

By MedTech Intelligence Staff
Coronavirus, COVID-19

The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.

This week the FDA made a major move to increase the availability of diagnostics that can detect the COVID-19 virus during this public health emergency. The agency issued Emergency Use Authorization to Hologic for its Panther Fusion SARS-COV2 Assay and LabCorp for its COVID-19 RT-PCR test.

“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, M.D. “Since the beginning of this outbreak, more than 90 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, more than 40 laboratories have notified us that they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. We stand ready to continue to support medical products in the pipeline to fight this virus.”

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