2 Companies on Track to Manufacture Millions of Coronavirus Tests

Roche Diagnostics Corporation CEO Matthew Sause delivers remarks during a news conference in which U.S. President Donald Trump announced the declaration of a national emergency in reaction to the ongoing global coronavirus pandemic in the Rose Garden at the White House March 13, 2020 in Washington. (Chip Somodevilla/Getty Images)

Two of the first companies to receive federal clearance for their tests for the Wuhan coronavirus are on track to produce millions of kits as early as April.

The Food and Drug Administration issued emergency authorizations this week for COVID-19 test kits by Roche, a Swiss pharmaceutical giant, and Thermo Fisher, a U.S.-based scientific instrument maker.

Roche has the capacity to manufacture up to 3.5 million tests per month, according to Karsten Kleine, a company spokesperson.

“We are working around the clock to increase that quantity, as we recognize the importance that patients need access to these critical tests,” Kleine said in an email to The Epoch Times.

Thermo Fisher will have 1.5 million tests ready to ship by March 16 and plans to ramp up production to 5 million tests per week by April 3, according to Ron O'Brien, a company spokesman.

“This will depend on a series of raw material and other manufacturing operations that need to scale successfully,” O'Brien said in an email to The Epoch Times.

The Roche test provides results in 3 1/2 hours. The Thermo Fisher test takes four hours. Both tests can be run on the companies’ diagnostic machines, which are already available at labs around the country.

President Donald Trump highlighted Thermo Fisher and Roche during a press conference on March 13.

“I’d also like to thank Thermo Fisher,” the president said. “The FDA’s goal is to hopefully authorize their application within 24 hours—it’ll go very quickly; it’s going very quickly—which will bring, additionally, 1.4 million tests on board next week and 5 million within a month.

“I doubt we’ll need anywhere near that.”

The tests by Roche and Thermo Fisher are part of a public–private sector plan by the coronavirus task force led by Vice President Mike Pence. The plan will feature a website created by Google that will pre-screen patients. Those who are eligible for a test will be given a nearby drive-thru testing site, with Walmart, CVS, Target, and Walgreens pitching in by providing parts of their parking lots for test sites. The nation’s largest lab testing companies, LabCorp and Quest Diagnostics, are working to process the tests on a large scale.

The Roche spokesperson noted that the company ships tests all over the world, suggesting that not all of the output may be destined for the United States.

“We are working with government organizations and regulatory bodies to ensure that the tests make the greatest patient and community impact,” Kleine said.

Since the number of test kits that will become available is part of a larger operation, its effectiveness will depend on the rollout of the other components, including drive-thru sites and lab diagnostics.

Since the beginning of the coronavirus outbreak, more than 80 test developers have applied for FDA approval. The FDA has approved four tests to date. The Thermo Fisher test was approved within 24 hours of request, according to the FDA.

“The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc Casper, president of Thermo Fisher, said in a statement.

“Over the last weeks, our emergency response teams have been working hard to bring this test to the patients,“ Thomas Schinecker, the CEO of Roche Diagnostics, said in a statement. ”Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic.”