FDA Issues emergency authorization to COVID-19 diagnostic Kit

U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit. It approved Thermo Fisher Scientific Inc's coronavirus test, which would allow the firm to increase capacity to 1.4 million tests a week, a Trump administration official said.

The FDA issued a EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive a EUA during the COVID-19 outbreak.

"This will dramatically increase our ability to test people for the virus," the official said. It was not immediately clear if capacity referred to test kit production or processing of tests performed on individual patients.

The move comes as the Trump administration struggles to meet the demand for testing. The FDA has already approved emergency authorization for a faster coronavirus test made by Swiss diagnostics maker Roche.

Trump has blamed his administration's lag in testing for the virus on rules and regulations inherited from the previous administration.In a news conference held in the White House Rose Garden earlier on Friday, he said the federal government was partnering with the private sector to ramp up test kit production to make them more widely available to Americans.

"This action today shows our agency's dedication to working around the clock to review and authorize diagnostics during this public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. The number of products in the pipeline reflects the significant role diagnostics play in this outbreak and the large number of organizations we are working with to bring tests to market."