FDA gives emergency OK to Roche's coronavirus test
New York state has the second-highest number of confirmed cases at 328
The Food and Drug Administration has given emergency authorization to a commercially distributed coronavirus test from Swiss multinational health care company Roche as the government seeks to more quickly identify and contain COVID-19 cases.
The regulator said Friday it is also allowing the state health department in New York, a disease hotspot in the U.S., to begin authorizing tests at certain laboratories independently of the FDA.
"These labs will interact solely with the New York State Department of Health, which should expedite the availability of patient testing," FDA Commissioner Stephen Hahn said in a statement. The decision shows the agency's "extreme flexibility and adaptability during times of public health emergencies,” he added.
Nationwide, authorization of the Roche test will have a more significant impact.
"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic," Roche CEO Thomas Schinecker said in a statement. "It is important to quickly and reliably detect whether a patient is infected."
The drugmaker's emergency response teams "have been working hard to bring this test to the patients," Schinecker added. The FDA's authorization and CE-mark certification in Europe, showing that the test complies with the trading bloc's regulatory standards, "supports our commitment to give more patients access to reliable diagnostics," he said.
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Global COVID-19 cases jumped 6 percent overnight to 132,567, and the United States now has at least 1,600 confirmed cases and 41 deaths.
New York state has the second-highest number of confirmed cases, at 328, after Washington state's 457.
Former Commissioner Scott Gottlieb called the FDA's decision of the Roche tests "significant" in a Wednesday series of tweets.
"Will substantially increase patient testing capacity by end of next week by tens of thousands a day across all labs, commercial and academic," he said. "Will take time for labs to stand up these platforms; should roll out next week."
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In the meantime, steps taken by cities and states to limit large gatherings and promote social distancing, will have a tangible impact, he said, crediting states such as New York with leading the way.
The city of New Rochelle, near Manhattan, has been at the center of it all as more than 100 cases have been reported, New York Gov. Andrew Cuomo has said.
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Hospitals and other health-care systems will be able to run Roche's virus tests on the company's fully-automated systems that are widely available in the U.S. and around the world, according to a statement from the company.
The FDA is expected to approve more test kits in the next several weeks, but the number of COVID-19 cases in the country is also expected to increase significantly.
President Trump said Friday morning that testing for COVID-19 will soon happen on a “very large scale," while taking a shot at the former administration’s response to the swine flu.
“All Red Tape has been cut, ready to go!” Trump wrote in a tweet.