The Food and Drug Administration has given an emergency approval to a test made by Swiss drug and diagnostics maker Roche for detecting the Covid-19 virus.
The company said Friday that the FDA had approved an emergency use authorization, or EUA, for its Cobas SARS-CoV-2 test. The test is designed to use nasopharyngeal and oropharyngeal swab samples to detect the coronavirus using Roche’s Cobas 6800 and 8800 lab-testing systems. The systems are designed to provide thousands of results over a 24-hour period, the company said.
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“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic,” Roche Diagnostics CEO Thomas Schinecker said in a statement. “It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2. Over the last weeks, our emergency response teams have been working hard to bring this test to the patients.”
Other companies have been developing tests as well. On Tuesday, Zaragoza, Spain-based CerTest Biotec and Franklin Lakes, New Jersey-based BD said their test for the Covid-19 virus had received a CE mark and was available to clinical labs in countries that recognize the mark.
The news comes shortly after two major lab-testing companies, Quest Diagnostics and LabCorp, said they would begin testing patients. Nevertheless, the U.S. has remained badly behind other countries in its ability to test for coronavirus infection, leading to criticism of the Trump administration and fears that the U.S. could face a large-scale outbreak and see its healthcare system overwhelmed similar to that of northern Italy. Despite promises by Vice President Mike Pence that 1.5 million tests would soon be available, The Atlantic reported that only 13,953 tests had been conducted nationwide. By contrast, South Korea has been testing nearly 20,000 people every day.
According to a map maintained by Johns Hopkins University, there were more than 137,000 cases of Covid-19 confirmed around the world as of Friday afternoon, with China, Italy, Iran, South Korea and Spain being the worst affected. In the U.S., the number of cases stands at 1,268. Globally, more than 5,000 people have died from the disease.
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Photo: FDA (free of copyright protection)
