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.
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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.”
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.
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Does anyone know the actual number of tests completed for tested people? I keep seeing stuff on the number of tests “administered” which is not necessarily the same as the number of tests actually analyzed. Today the number for administered in CA is 8300, but have they all been analyzed?
To Jack Kuhns:
Sorry, I should have been more specific. Each standard kit from Thermo-Fisher (which recently acquired Qiagen) usually contains enough testing material for 50 or 250 samples (in this case a person’s throat swab + nose swab apparently – which also has to be sampled with supplies given to doctors/hospitals beforehand). I don’t know which size kits they are making for this extraction process, but the limit here is how many reagents they have available.
The additional materials the labs will need will be those essential to run RT-PCR (or some type of amplification process to copy the RNA). There are multiple types of thermocyclers, also called PCR machines, that do this. These are the machines that your asking about and they are very common. If the government is allowing universities and private companies to run the PCR then the capacity to do the tests will be very high. Probably higher than the amount of reagents that can be supplied for the actual RT-PCR reactions.
If the sites where the PCR can be run is limited, that will limit the number of tests that can be run per day, but it would still be rather high, since depending on the machine type you can run 96 samples or 360 samples at a time, and repeat the runs many times in a day.
FYI, to actually do the PCR you need special “primers” that essentially allow only the specific region of RNA you are “looking for” to be copied many times in the reactions. You need a reverse-transcription polymerase to copy RNA to DNA (I’m guessing this is the testing method, since it is the oldest and most common method for scoring presence/absence of specific RNA strands) and the polymerase will be in a mixture of reagents often called a “master mix” with nucleotides (to make the copies) and the correct additional compounds to keep the reaction stable. It is highly likely this “master mix” will be a limiting step for getting the tests run, since it must be produced in a very precise process or it won’t work consistently and will lead to big problems with the testing validity. The primers shouldn’t be a big problem to make, labs can get enough specific primers in a few days to run 10s of thousands of reactions.
need to be told the “master mix” quantities to set up the reagents with the samples and the parameters for setting the cycles on the machine. Then they could exactly replicate (or as exact as using different actual thermocyclers allows) the overall process. If the government only lets a limited number of laboratories do the QT-PCR it will take a longer.
That would usually be purchased separately with a special reverse transcription polymerase (for RT-PCR). (Elsewhere on stat news I incorrectly put that they would need to make RNA, but after thinking about it I don’t think they will do that with these kits, I think they will test the initial sample for RNA by extracting and purifying the RNA with the kits and then they will use Polymerase Chain Reaction to make cDNA from the RNA using RT-PCR).
Sorry, I meant to erase the comment part after the 4th paragraph where it starts without a capital letter at “need to be told” since I rewrote the explanation about PCR.
Is is true that Trump and/or Kushner are invested with Thermo Fisher?
I have the same question about links. I made a comment yesterday and added 2 links to excellent sources of information provided by a friend who is a microbiologist. The comment was never posted! By the way, if you use the Johns Hopkins Coronavirus resource center (site with an interactive world map too) you can get accurate up-to-date information. Including current rates of coronavirus in US by State. The numbers are updated at least every couple of hours. (Not that I check more than once a day – yikes, I don’t need to be constantly freaked out. We are definitely increasing steadily now there are a few more tests kits to actually look at more probable cases).