By Tim Loh
March 13, 2020, 2:29 AM EDT Updated on March 13, 2020, 8:31 AM EDT
- FDA grants emergency use approval to highly automated process
- Roche shares jump 11%, the most in more than two decades
U.S. health regulators have approved a new coronavirus test that will speed up by tenfold the ability to test patients, helping solve a significant obstacle to American efforts to contain the virus.
The Food and Drug Administration granted “emergency use authorization” to the test, which runs on Roche Holding AG’s cobas 6800/8800 systems. The 8800 system is capable of testing 4,128 patients a day, and the 6800 version can test as many as 1,440. The tool also is available in Europe and countries that accept its CE marking for medical devices.
Roche shares traded 11% higher at 1:29 p.m. in Zurich, the steepest intraday increase since 1997.
“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, head of the Swiss drugmaker’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 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 U.S. 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 U.S., and Roche has installed a “significant amount” of new ones in key locations in the U.S. 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 U.S,” 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 U.S., 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.