FDA Approves Emergency New Coronavirus Test To Boost Screening In The U.S.

Topline: The Food and Drug Administration issued emergency approval for a new automated test for the coronavirus in a boost for efforts to slow the spread of Covid-19.

• The FDA approved the test that will be run by Swiss pharmaceutical giant Roche’s automated testing machines. The machines are already in 100 American laboratories.
• Roche’s diagnostic machine will be able to run up to 4,000 tests per day and will give doctors the result in less than four hours.
• “We are increasing the speed definitely by a factor of 10,” said Thomas Schinecker, head of Roche’s diagnostics unit, in an interview with Bloomberg.
• Roche said it was going to the limits of its capacity to produce more testing kits.
• The new test could help healthcare workers work to quickly identify patients with the coronavirus after efforts to contain the outbreak were setback by defective test kits distributed by the U.S. government, and limited availability of other tests for the virus. 
• Schinecker said that it is working with the CDC, and that more tests will be deployed where they are needed most, particularly in Washington State which has recorded the majority of the 41 coronavirus-related deaths in the U.S.

In numbers: More than 133,000 people around the world have been diagnosed with Covid-19 since the outbreak began in December last year, while nearly 5,000 people have died, according to the European Centre for Disease Prevention and Control.

Key background: There have been 1,660 confirmed cases of the coronavirus in the United States but health researchers are concerned that the true scale of the outbreak could be much greater because of limited access to tests for the Covid-19 disease. Faulty test kits and a lack in early testing is believed to have contributed to the further spread of Covid-19, epidemiologists at Johns Hopkins university wrote in the Journal of the American Medicine Association this week. Vice President Mike Pence, head of the administration’s Covid-19 task force, has pledged to make more test kits available, while the FDA signed off on new tests developed by the CDC in February.

South Korea and the U.S. recorded their first cases at around the same time, between January 21 and 23. Yet the U.S. has tested some 8,000 people, one count by The Atlantic estimates, while South Korea, which has been one of the worst affected countries, has tested more than 200,000 people. There is currently no treatment for coronavirus, while a vaccine is at least a year away from being available.