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.
“The authorization of our diagnostic test for Covid-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Thermo Fisher CEO Marc Casper said in a statement.
The number of people who could be tested using those supplies will likely be lower than those figures, because people often require multiple tests during the course of diagnosis and treatment. Much also depends on the local testing capabilities wherever those tests are put to use. But together, they represent a massive improvement over the status quo. As of Monday, the United States had the ability to process only about 37,000 tests per day, according to the American Enterprise Institute, which has kept a daily tally.
Ron O’Neil, a Thermo Fisher spokesperson, told WIRED that the company is in discussions with commercial labs, like Quest Diagnostics and LabCorp, to make its test widely available. Roche officials said in a statem
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