Thermo Fisher to produce millions of coronavirus diagnostic tests

Thermo Fisher, the largest maker of scientific tools, said Friday it plans to produce up to 5 million of a new test to detect the novel coronavirus that causes Covid-19.

The company, based in Waltham, Mass., plans to reach that level of production by the week of April 3, according to Ron O’Brien, a company spokesman.

The Food and Drug Administration granted the new test an emergency clearance late Friday.

Before Friday, the U.S. had struggled to increase its capacity to test for the virus, a key step in trying to limit the damage of the pandemic it is causing. According to a count kept by the American Enterprise Institute, a think tank, the country currently has the ability to run 26,000 tests a day. Another diagnostic test, made by Roche, was approved Friday morning. Roche said it could manufacture 400,000 tests a week.

“This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency,” said FDA Commissioner Stephen Hahn in a statement Friday. “We have been engaging with test developers and encouraging them to come to the FDA and work with us.”

Hahn said that the FDA has been in touch with 80 tests developers that plan to bring their tests through its emergency process.

The Thermo Fisher test will run on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is already used in clinical laboratories.

“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,” said Marc Casper, the chairman, president and CEO of Thermo Fisher, in a statement.

Thermo Fisher was briefly mentioned at a Friday afternoon press conference held by President Trump, who talked of the company’s scaled-up production.

“I’d also like to thank Thermo Fisher,” Trump 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.”

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

At the press conference, Trump administration officials had said that the number of tests would dramatically increase, and it would take a shorter amount of time to return results. Currently, it can take several days. Ambassador Deborah Birx, a physician and public health expert who is the White House coronavirus response coordinator, said the goal was to begin returning results in as little as 24 hours.

Officials said that getting tests to patients has posed a logistical problem as well, and outlined plans to partner with private industry to create drive-through testing centers.

Tests are actually administered by diagnostic laboratories, including large companies like LabCorp and Quest Diagnostics. Manufacturing test kits does not mean they will immediately reach patients. But the availability of so many tests would be a major step forward.

Correction: A previous version of this story misstated the current test capacity of the U.S.