FDA Approves the First Commercial Coronavirus Tests in the US


Swiss pharmaceutical giant Roche and medical-device maker Thermo Fisher collectively have nearly 2 million tests available, with more to come.

After a weeks-long shortage of COVID-19 tests and limits on screening that have hampered officials’ ability to respond to the crisis, the first commercial tests for the disease have received approval from the US Food and Drug Administration. The new tests could dramatically increase the number of people who can be screened.

Both tests received approval on Friday, less than 24 hours after the companies submitted their applications to the FDA. “This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency,” FDA commissioner Stephen Hahn said in a statement.

Officials from Roche, the Swiss pharmaceutical giant, say the company has 400,000 tests ready to be shipped and plans to manufacture 400,000 more per week. Medical-device maker Thermo Fisher representatives say they have 1.5 million of their own test available, and a goal of producing 5 million per week by April. Both companies have promised their tests can turn around results in a matter of hours.

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