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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.

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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.

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“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.”

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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.

  • I had a reply to Mr Pete @ 12:26 PM that was apparently moderated out of existence. I asked him for some substantiation of the assertion that California has the capacity to process 7000+ tests/day, and provided a few newspaper links that suggested otherwise. I’m pretty sure I didn’t use any offensive language or attitude. Was it the use of the links that was ‘illegal’?

  • Need to distinguish between test kits and testing capacity, viz. number of tests each “kit” can handle.
    Also, are the pricey-looking PCR machines a bottleneck? And are the Roche and T-F models interchangeable or only usable for the proprietary tests.

    BTW Thermo Fisher doesn’t “manufacture” tests, just kits and the PCR machines used to run them.

    • What do you mean? The kits are the tests! The special type of PCR machines needed for copying RNA are very expensive but tons of laboratories already have them and they work very quickly, and can run many samples concurrently (depending on the machine at least 96 at a time, but many run 360).

    • Paige, no kits are not each, tests. They handle multiple tests. Again, are PCR machines a bottleneck?

    • They go part and parcel: cures or mitigation follow diagnosis. It might be flu, a separate test.
      The blood test for antigens/antibodies is separate from the active COVID19 test via swab or aspirate; these vary somewhat (RNA etc.) as Cable conflates tests and test kits and Dr. Fauci et al do little to clarify.

  • I have a couple questions- does “run” mean test administered, or does it mean the number of tests being processed in labs across the United States? I ask because I’ve also read that the US is only capable of processing 8 thousand tests per day (the hospital I work at is sending out to two locations, one in-state and one out-of-state)
    Also, how does number of tests/day equate to number of patients tested per day?

  • I’ve been an investor in diagnostics companies for a long time. We have, in the past, waited months or years for an EUA. I knew the FDA could do this much faster. Just needed some political pressure.

    • I don’t think the problem is so much with RNA extraction, but rather with reagents needed for RNA copying using Polymerase Chain Reaction. I can use my labs DNA extraction kits and get tons of RNA isolated with the DNA (actually a problem most of us in molecular labs have to deal with if we work with DNA). I can’t copy RNA though, because I would need a different copying molecule (RNA polymerase) and a different set of nucleotide bases to replicate the sequence (RNA has uracil, thymine, cytosine and guanine while DNA has adenine, thymine, cytosine and guanine). Also, I believe the chemistry of the rest of the mixture added is somewhat different due to the much less stable structure of RNA (it’s a single helix, unlike DNA).

  • Should be interesting how they handle this. Thermo was supposed to send us a shipping container for a defective PCR machine. They can’t process the order because they don’t have boxes and no idea when this will be resolved. How are they going to send out 5 million kits?

  • Fact Check: The other article I read on this site says “The U.S. currently has capacity to run just 175,000 tests a week.” This article says we have the ability to run 26,000 tests a week. The source of both figures actually says 25,175 tests per day.

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