On Monday, the U.S. Food and Drug Administration took two additional significant diagnostic actions during the coronavirus outbreak (COVID-19) by issuing 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.
“Staff at FDA have been working nonstop to expedite the review and authorization of diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D.
“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.
“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.”
Hologic began research for a new coronavirus test as soon as the COVID-19 outbreak emerged in China. Since January, our company’s development and manufacturing teams have worked around the clock to create the test, which runs on Hologic’s Panther Fusion system, and prepare for its market rollout.
“We at Hologic feel incredibly proud to be right on the leading edge of testing breakthroughs that will help lead the world out of this COVID-19 pandemic,” said Steve MacMillan, Chairman, President and CEO of Hologic.
Now, Hologic can immediately begin shipping the product to labs across the United States. Starting in April, we expect to make almost 600,000 of these tests per month.
Panther Fusion, launched about three years ago, automates the complex steps involved in molecular diagnostics. This automation not only speeds up diagnostics but also reduces the chances for error when compared to the traditional lab setup, which has many manual processes.
Panther Fusion is also distinctive because of its high testing throughput, small footprint compared to other high-throughput competitors and versatility in being able to run 16 different FDA-approved tests.
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