Subscriber Benefit
As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowRoche Diagnostics, whose North American headquarters is in Indianapolis, said Monday that it has begun shipping an initial order of 400,000 COVID-19 test kits to a network of more than 30 hospitals and laboratories across the country.
U.S. health regulators last week approved the new coronavirus test, which is expected to speed up by tenfold the ability to test patients, helping solve a significant obstacle to American efforts to contain the virus.
“We are increasing the speed definitely by a factor of 10,” Thomas Schinecker, CEO of Roche Diagnostics, a division of Swiss drugmaker Roche Holding AG.
The Food and Drug Administration granted “emergency use authorization” to the test, which runs on Roche Holding’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 Holding shares rose 3.4% Monday amid major losses in the overall stock market.
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.
“We are grateful to the FDA for accelerating the process to grant Emergency Use Authorization for this test,” said Matt Sause, president and CEO of Roche Diagnostics North America. “We began shipping test kits immediately so labs could start to offer high-volume testing as soon as possible and give more patients access to reliable diagnostics. Together, we can help combat this serious disease.”
Roche said it consulted with government agencies to ensure that the test distribution prioritizes labs with the broadest geographic reach and highest patient impact. Health care providers across the country can send patient samples to these laboratories for processing.
Roche employs about 3,000 people on its large campus at 9115 Hague Road on the north side of Indianapolis. It makes machines and software to help physicians, hospitals and laboratories analyze data and diagnose patients, along with machines and test strips for diabetes patients.
Please enable JavaScript to view this content.
Isn’t it great that we have a President who wants to work WITH American industry, and has a reputation for doing so, rather than some socialist nitwit with a track record of demonizing them for being capitalists? What goes around, comes around: FDR was no great friend of business, but he was smart enough to work closely with American industry to establish the Arsenal of Democracy that kept all of us from speaking German and eating sauerkraut three times a day.
The coronavirus virus reality has at least one silver lining: It has kept tweedle dumb and tweedle dee (A/K/A Sanders and Biden) off the airways and dominating the news cycles with their collective stupidity….although it is a terrible price to pay.
Really??? The Donald claims he’s “not responsible” for anything (even though as suspected he gives himself a “10” on his actions). This has been quite apparent with the Administration’s lack of timely response to this entire situation. Good though for Roche!
Really, Jay D.? Be honest: I’ll bet you a dollar to a doughnut that the only thing President Trump could do to make you happy would be to resign.
I can’t imagine the horror of this situation if that dingbat Hildebeast was President, She’d be so worried about “offending” anyone that she wouldn’t restrict anything until half the country was infected…and then she’d find a scapegoat on which to blame the whole situation.
You Trump haters are a PITA.
It’s evident you learned from your master well. Just like DT, you don’t have any knowledge of what you are talking about. So you resort to demagoguery and hate speech. Why don’t you try to learn something before your next post. You are only embarrassing yourself.
By now, President Trump knows more about this situation than you and I put together several times over, Lester.
So what do you know that I don’t? You seem so self-assured.