LabCorp, Hologic COVID-19 Tests Receive Emergency FDA OK

The US FDA has issued Emergency Use Authorizations (EUAs) to Hologic for its Panther Fusion SARS-COV-2 Assay, and LabCorp for its COVID-19 RT-PCR test, according to an agency news release.

The LabCorp test takes approximately 4-5 days for results, according to the company’s fact sheet.

Hologic’s Panther Fusion SARS-COV-2 Assay can provide results in less than three hours and process up to 1,150 coronavirus tests in a 24-hour period, according to a company press release.

“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,” said FDA Commissioner Stephen M. Hahn, MD. “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.”