- The US FDA has approved a new coronavirus test that is 10 times faster in detecting the disease
- American government granted Roche Holding AG an emergency use of the kit to test patients
- Coronavirus has been declared world endemic disease by the World Health Organisation (WHO)
The United States government has approved Roche Holding AG for a highly automated coronavirus test, potentially speeding up tenfold the ability to test patients.
Bloomberg reports that the US Food and Drug Administration (FDA) granted an “emergency use authorisation” to the test, which runs on Roche’s cobas 6800/8800 systems.
Legit.ng gathered that Roche said the tool also is available in Europe and countries that accept its CE marking for medical devices.
The 8800 version is capable of testing 4,128 patients a day, and the 6,800 can test as many as 1,440, the Basel, Switzerland-based company said.
The report also noted that Roche shares climbed as much as 4.9% early Friday, March 13, leading the Stoxx Europe 600 index.
“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of Roche’s diagnostics unit, said in an interview.
"Testing is crucial to stem the spread of Covid-19 because it allows health care workers to identify the infected and quarantine them, even if they’re not experiencing any symptoms. That can potentially reduce the overall number of infections and buy time for drugmakers to come up with better treatments and, ultimately, a vaccine.
"This is the third test and first commercially available one granted emergency approval by the FDA. The agency in February cleared diagnostic tools brought forth by the CDC and the New York State Department of Public Health," the statement read.
It was gathered that the US and much of Europe have been criticised for testing their populations too slowly, allowing the virus to proliferate.
Roche’s cobas systems, launched in 2014, are widely available globally, with 695 of the 6800 instruments and 132 of the 8800 systems already installed.
There are 110 of these tools in the US and Roche has installed a “significant amount” of new ones in key locations in the US in recent weeks, Schinecker said.
Roche declined to specify how many of those units are 8800 and how many are 6800 models.
“We definitely extended the capacity of the testing significantly throughout the US. The cobas 8800 system can test patients about 10 times faster than Roche’s existing test for the coronavirus, which runs on its MagNA Pure 24 and the LightCycler 480 devices.
"While those instruments require more human attention, there are more of them in labs and hospitals around the world. They’ll continue to play a crucial role in testing people, especially outside the US.
Meanwhile, Legit.ng had previously reported that a 64-year-old Nigerian, Okunuga Olumide Saraju, was found dead in his home in Modena, Italy, where he lived alone.
It was gathered that Okunuga, a native of Ikenne in Ogun state and the president of Egbe Omo Yoruba in Emilia Romagna region, was found dead at about 11 am on Tuesday, March 10, at his home.
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