New coronavirus test 10x faster approved by FDA

Roche Holding AG said it won emergency approval from the US government for a highly automated coronavirus test, potentially speeding up the ability to test patients by a factor of 10.

The US Food and Drug Administration granted an “emergency use authorization to the test, which runs on Roche’s cobas 6800/8800 systems. The tool also is available in Europe and countries that accept its CE marking for medical devices, Roche said.

The 8800 version is capable of testing 4,128 patients a day, and the 6800 can test as many as 1,440, the Basel, Switzerland-based company said. Roche shares climbed as much as 4.9 percent early Friday, 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 many symptoms. That can potentially reduce the overall number of infections and buy time for drug makers 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 US and much of Europe have been criticized 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,” Schinecker said.

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, Schinecker said.

The cobas 6800/8800 instruments provide test results within four hours. Roche can provide millions of tests every month for the systems and is “going to the limits of its production capacity,” the company said. Roche declined to comment on pricing for the tests.

The tests analyze nucleic acids extracted from patients’ saliva or mucus, and compare them against sequences found in coronavirus strains, including SARS and the one that emerged in Wuhan, China.