FDA Issues COVID-19 Diagnostic Emergency Use Authorization to Hologic, LabCorp

The FDA has announced 2 new diagnostic emergency use authorizations (EUAs) in an effort to expand testing availability for the novel coronavirus (COVID-19).¹

The authorizations have been given to Hologic for its Panther Fusion severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 Assay and to Laboratory Corporation of America (LabCorp) for its COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test.¹

“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, in a statement. “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.”¹

The RT-PCR test from LabCorp detects the presence of the underlying virus that causes COVID-19 and is approved for use in patients who meet current guidance for evaluation of COVID-19 infection.²

According to a press release from LabCorp, the company expects to have the ability to perform more than 10,000 tests per day by the end of the week and 20,000 tests per day by the end of March.²

Researchers at Hologic began developing their SARS-COV-2 Assay test when the outbreak began. It was the first COVID-19 diagnostic to receive developmental support from the United States Biomedical Advanced Research and Development Authority, including nearly $700,000 in funding.³

The Panther Fusion technology automates the steps involved in molecular diagnostics, which can accelerate the diagnostic period while reducing the chances for error. The SARS-CoV-2 test from Hologic also allows clinicians to test from the same patient sample and collection vial that they currently use to diagnose other common respiratory viruses.³

According to a press release from Hologic, the company can immediately begin shipping the tests to labs and expect to make nearly 600,000 tests per month beginning in April.³

REFERENCES

• Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp [news release]. US Food and Drug Administration; March 16, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp?utm_campaign=031620_PR_Coronavirus%20%28COVID-19%29%20Update%3A%20FDA%20Issues%20Two%20More%20EUAs&utm_medium=email&utm_source=Eloqua. Accessed March 17, 2020.
• Hologic’s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization [news release]. Hologic; March 16, 2020.https://www.hologic.com/coronavirus-test. Accessed March 17, 2020.
• Information from LabCorp about Coronavirus Disease 2019 (COVID-19) [news release]. LabCorp; March 16, 2020. https://www.labcorp.com/information-labcorp-about-coronavirus-disease-2019-covid-19. Accessed March 17, 2020.