FDA grants Roche coronavirus test emergency green light within 24 hours
fiercebiotech.com
fiercebiotech.com
- Roche has been working on this already for weeks with high priority.
- These are tests that run on high-throughput machines, namely the Roche Cobas 6800/8800 systems:
https://www.dialog.roche.com/pk/en_us/products_and_solutions...
- One Cobas 8800 is able to perform 4100 tests per day in a fully automatic fashion.
- There are roughly 800 Cobas 6800/8800 in Europe, US and Asia combined.
- One test costs about 15 CHF (which is roughly 15 USD) (EDIT: This is what Roche gets per test. The overall laboratory cost is probably much more expensive).
- Roche is pretty much the only manufacturer for machines like these.
Source (German):
https://www.faz.net/2.1690/pharmakonzern-roche-neuer-schnell...
EDIT: More exact numbers in the linked article: Cobas 6800 can do 1440 tests/day, Cobas 8800 4128 tests/day.
https://www.youtube.com/watch?v=6P-jaC3_d3o
The dramatic trailer music is quite adequate, IMHO.
[0] https://www.gsaadvantage.gov/ref_text/V797P7347A/0UZLK9.3QPY... , page 13
But good point about cross contamination, still could be there is a mechanism to counter that, like some vapour pressure tricks or gas streams preventing fumes from one open container reaching another.
The tests are detecting levels of antigens, antibodies, or DNA in the sample. The samples are manipulated with disposable parts to prevent crossover.
Technology is great. Before this product it would probably take an entire university campus with multiple labs full of technicians to do the number of tests this is doing.
Designed to provide a fully integrated real-time PCR workflow,
the cobas® 8800 system can run up to 960 tests in an eight-hour
shift with minimal user interactions and up to four hours of
walk-away time per run when running at maximum capacity.
Update: formatting
That is, it takes time to "stuff the pipeline".
The cited number -- 4128 -- appears to be 21.5 * 192.
So if that is true, it isn't labs multiplied by the PCR rate to get to a testing rate, it's the sum of the bottlenecks of the installations.
https://thehill.com/policy/healthcare/other/487393-fda-grant...
eg biorad makes and sells tons of (much simpler), typically 96-well rtPCR machines. You can find them on ebay for like $5k. Training people to use them is not particularly hard, and you can probably do 4-8 runs / day on one of them. NB: 96 will means you probably can process 88-92 samples per run plus 4-8 controls.
The limiting factor is approved tests and reagents, laboratory bench time to prep samples, and a distribution mechanism to get test kits to to people and then to labs.
Though Roche makes the only huge machines like this, there's lots of high-automation rtPCR out there. And you can fit a lot of e.g. Abbott m2000's in the floor space that one Cobas 6800 takes, picking up some flexibility and each doing ~500 a day.
What is Roche's manufacturing capacity for these panels each week for the US in the next four weeks? With the 110 machine figure someone else reported in this thread, there is a theoretical limit of about 451K Roche tests per day assuming we shove aside all other testing on this gear, but we could be supply-constrained by these proprietary panels instead. In which case we really should get BD MAX, Seegene All-In-One Platform and similar S. Korean solutions' approvals from the FDA specifically for their Covid-19 panels for their systems on an national emergency basis.
Caveats: getting to Roche level of throughput and scale would be tricky with just Arduinos and off the shelf stuff and there are some magic numbers that you will have to figure out through experimentation. Building a usable machine just for a small number of people is not that tricky if you have e.g. 5 bio and 5 CS/EE people working on getting a design shipped.
They use molecular water (double-distilled, deionized, likely de-salted water), and DNA and RNA degradation solutions, some PPE, autoclaves, bleach, and lots of workflow procedures to carefully mitigate cross-contamination.
I'm curious why the life sciences folks aren't standardized upon something like semiconductor SMIF to isolate the samples and point of contact of equipment into a modular sterile environment, and limit cleaning to interface ports optimized for sterile operations and maintenance. My first swag at such interface ports might look into some design that can be clamped and autoclaved, and submerged in some degradation solution, for example. Generally, the current open standard is terrifically manual labor intensive and prone to mistakes.
All the automated solutions I've been able to read up on so far (BD MAX, Seegene All-In-One Platform, Roche Cobas 6600/8800, BioFire FilmArray Torch and FilmArray 2.0) seem to lock in customers to proprietary panels. I'm curious whether that is more of a commercial decision or a scientific decision. Of these, only BD MAX allows user-designed protocols at all.
So far, I've yet to see a persuasive argument that an automated molecular diagnostics system must use a proprietary platform for scientific reasons. A generic automated platform that can use anyone's glassware, molecular water, primers, master mixes, etc., will need many more sensors for quality monitoring, and those need constant calibration, so there is a significant engineering tradeoff. But I'd be surprised if any of the proprietary solutions are much more cost-effective; it seems all of these kinds of solutions are following the John Deere lock-in servicing model to generate profits.
The decision to lock people is for FDA approval. FDA approval means more labs can run your test and reimbursement is more of a sure thing.
edit: There are some informal standards like 96- and 384- well plates that make it possible to have third-party consumables with some machines, but there is no incentive for a for-profit company to design open platform.
One of the companies I used to work for had a large chemistry system that could be run "open" but only a few customers used it that way, a couple research laboratories and I think a winery. Thousands of other instruments were used for plain ol' medical testing.
Even if you designed a sufficiently open system that could run Roche or Siemens reagents or whatever, any problem with the reagents and the company will just shrug and say "it's not our instrument, no guarantees."
https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-...
What method do you propose without a thermocycler?
https://www.worldometers.info/coronavirus/covid-19-testing/
Everyone else seems fairly low throughput, with the US being on the "ridiculously low" end of that spectrum if you consider tests per million of population.
http://www.thermofisher.com/order/catalog/product/4406985
(Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS 1.4 software.)
I'll bet the Roche doesn't require a PC running Windows software that still needs manual defragging:
> When to Clean Up and Defragment the Hard Drive
> • At least once every month
> • When a message is displayed by the Windows operating system instructing you to defragment
https://assets.thermofisher.com/TFS-Assets/LSG/manuals/44069...
(Page 47)
I do that on my home machines. All updates are disable and I manually enable them every 6-12 months to let win10 to go crazy for a day or so and everything is up to day.
One can also monitor the podcast such as "Security Now" to check if the latest windows update processes have any special BSOD or silently / randomly delete all users files/profiles before turn on the update.
https://www.theatlantic.com/health/archive/2020/03/why-coron...
Several states like Colorado use these alternative tests calling results 'presumptive'. The Roche machine is a welcome addition.
Health care strategists know the testing has limitations and have pretty sophisticated models to extrapolate population level statistics from known test results. For example in the UK they reckon the prevalence in the population is from 10x to 20x the number of positive test results.
For example, the US auto industry has mostly moved to metric for designing new cars.
From what I've heard, the vast majority of civil and structural engineering in the US is still on customary. (A few state highway departments tried to move to metric, but actually ended up moving back, since using metric when the rest of the industry was still on customary was costing them more money.)
US aerospace is still mostly customary, but NASA has been encouraging greater use of metric in space applications (due to the Mars Climate Orbiter debacle). And you'll notice SpaceX's webcasts all have metric units for telemetry – I believe SpaceX prefers metric wherever possible.
The funny thing is looking back at Apollo documents from the 60s is that many of those were in SI, but for Shuttle they appeared to have switched the launch and land portion fully to English.
Actually, many planes support displaying metres for altitude as well as feet. This is because, while most of the world uses feet for altitude, a handful of countries (China, North Korea, some ex-Soviet states) use metres instead. On an international flight, pilots can even change the units displayed on their instruments as they pass from non-metric airspace into metric airspace and vice-versa.
You can see some of the approaches here: https://www.thorlabs.com/tutorials.cfm?tabID=4068826A-1CD4-4...
(I work with CNC and I spend much of my day converting between inch and mm).
Is this actually possible to do — my instincts say that any exponentially transmitting contagion will make it impossible to assess such stats with any confidence for quite some time ...
E.g. if a country could test 10% of the population in a month, wouldn't that help the "everyone is a potential bearer"-lockdowns we see now and help achieve some normality? Or is mass testing too expensive or wasteful? Or would the information not be valuable enough to do it?
Some of this may be sensitivity of early tests, but it's mostly that not everyone who has the virus has copious amounts of it in their snot all of the time.
The point is, testing everyone may be useful in slowing spread-- may be able to prove people as infectious and needing isolation. But it is not useful in proving people safe.
https://www.biofiredx.com/products/the-filmarray-panels/film...
while covid19 test is critical, and would have had more time to come to market if the president had just accepted WHO kits instead of refusing them for US profit, just a reminder if you have flu-like symptoms and fever regardless of virus strain you should not being going out in public anywhere anyway (but pointless to say, people coughing up lungs in stores, at schools and around my apartment complex)
No. Refusing them because of US government red tape and bureaucracy.
~~The same company also own a majority stake in Labcorp which runs one of the largest amounts of clinical labs in the US.~~
Edit: actually their ownership of LabCorp is no longer clear, I believe from reading Wikipedia that they sold ownership a while ago
Roche sold their stake in 2002.
I haven't followed this very closely, so my impression was that that was the CDC's decision/regulation - is that not the case?
Regardless of which political party is in power I would say on-the-ground decisions are made by the non-partisan staff at the CDC within the bounds of all existing regulations.
The red tape and disaster declarations are the key levers that the Administration has control over, and it appears to me that they are taking unprecedented steps here to clear the way for testing which was impossible based on existing FDA regulations preventing private and even state run public labs from deploying their own testing.
What sounds like a good idea in general (“FDA approval is required before you can offer any diagnostic health test”) doesn’t work very well during a crisis which requires extremely widespread deployment of a relatively simple but novel test.
“While any other day we are competitors, today we all have a common competitor, and that is COVID” was a beautiful line.
It’s emblematic of the US approach (I won’t say a Republican approach) to instead of showing a lineup of government officials to show a lineup of corporate officers saying that they are making this their mission.
My own political leanings gives me more faith seeing these CEOs commit yesterday to fighting this than anything the CDC or the FDA could announce.
So I personally give the Trump Admin a lot of credit for orchestrating that, and I’m excited to see them deliver on their promises in the next couple weeks. I think they moved quickly to close the border with China, and then we lost precious weeks when the CDC failed.
Certainly I would not expect any Administration to revamp FDA guidelines on testing before it became clear they were an obstacle. Overall we’ve moved incredibly fast in getting to a National Emergency declaration (e.g. compared to H1N1).
Honestly it may have been his “9/11 moment” and I thought he nailed it. Not with eloquent speech to be sure. But in the actions being taken.
They are holding press conferences daily. Adjusting to the situation. Daily. He has changed course multiple times regarding his position on things.
Fail fast and course correct. That's the whole "agile" thing, and it seems to me the country is doing a pretty damn decent job of it.
Testing has been the main shortfall so far in our response. It's getting fixed as we speak. That should make people happy.
I saw a clip today of the Surgeon General basically saying "Stop nitpicking and start helping." This is a national emergency. Time to start acting like it.
Because Trump is a moron enabled by a political class that displays outright contempt for the public, who completely mismanaged his government's response to this crisis, mislead the public as to its severity, and deflected responsibility for his actions.
January 22: “We have it totally under control. It’s one person coming in from China. It’s going to be just fine.”
February 2: “We pretty much shut it down coming in from China.”
February 24: “The Coronavirus is very much under control in the USA… Stock Market starting to look very good to me!”
February 25: “CDC and my Administration are doing a GREAT job of handling Coronavirus.”
February 25: “I think that's a problem that’s going to go away… They have studied it. They know very much. In fact, we’re very close to a vaccine.”
February 26: “The 15 (cases in the US) within a couple of days is going to be down to close to zero.”
February 26: “We're going very substantially down, not up.”
February 27: “One day it’s like a miracle, it will disappear.”
February 28: “We're ordering a lot of supplies. We're ordering a lot of, uh, elements that frankly we wouldn't be ordering unless it was something like this. But we're ordering a lot of different elements of medical.”
March 2: “You take a solid flu vaccine, you don't think that could have an impact, or much of an impact, on corona?”
March 2: “A lot of things are happening, a lot of very exciting things are happening and they’re happening very rapidly.”
March 4: “If we have thousands or hundreds of thousands of people that get better just by, you know, sitting around and even going to work — some of them go to work, but they get better.”
March 5: “I NEVER said people that are feeling sick should go to work.”
March 5: “The United States… has, as of now, only 129 cases… and 11 deaths. We are working very hard to keep these numbers as low as possible!”
March 6: “I think we’re doing a really good job in this country at keeping it down… a tremendous job at keeping it down.”
March 6: Anybody right now, and yesterday, anybody that needs a test gets a test. They’re there. And the tests are beautiful…. the tests are all perfect like the letter was perfect. The transcription was perfect. Right? This was not as perfect as that but pretty good.”
March 6: “I like this stuff. I really get it. People are surprised that I understand it… Every one of these doctors said, ‘How do you know so much about this?’ Maybe I have a natural ability. Maybe I should have done that instead of running for president.”
March 6: “I don't need to have the numbers double because of one ship that wasn't our fault.”
March 7: “We’ll hold tremendous rallies...I’m not concerned at all.”
March 8: “We have a perfectly coordinated and fine tuned plan at the White House for our attack on coronavirus.”
March 9: “This blindsided the world.”
March 10: "Our CoronaVirus Team has been doing a great job. Even Democrat governors have been VERY complimentary!"
March 11: "I am fully prepared to use the full power of the Federal Government to deal with our current challenge of the CoronaVirus!"
March 12: "108 countries are dealing with the CoronaVirus problem, some of which we are helping!"
March 13: "To this point, and because we have had a very strong border policy, we have had 40 deaths related to CoronaVirus. If we had weak or open borders, that number would be many times higher!"
March 13: "Today I am declaring a national emergency. Two very big words."
March 13: "No, I don't take responsibility at all."
Why are people resistant to this argument? We. Fucked. Up. It's maybe not productive to argue about recriminations at this point, but if so it's even worse to try to excuse it away or pretend that it didn't happen. It was a terrible mistake, and right now it looks like lots of people are going to die because of it.
Shorting the market in January and February would've been more of a bet on government inaction than a bet on any inherent characteristics of the virus.
Many predicted large epidemics in multiple countries, but the CDC/FDA testing fiasco, or the lackluster response in EU wasn't easy to predict.
I agree with OP that "everyone should stop pretending that 'no one could have known'". The probability of having a large epidemic in each country was significant, definitely above 2%. That number alone would've warranted ramping up production of test kits and sanitary supplies, building fever clinics, doing emergency drills, and setting up some data sharing infrastructure between healthcare providers. Most developed countries didn't do any of that.
regardless, moves made by a small private investor don't really matter in the grand scheme of things. just don't panic sell.
The “Pandemic” designation wasn’t appropriate back then because it just wasn’t a pandemic at that time. They very clearly said it was on its way to becoming one.
I’m starting to suspect this griping about the WHO is somehow motivated. People tend not to be this willfully stupid unless politics are involved.
(Even though it was obvious to anyone with half a brain in January that this thing was going to spread and become a global problem in no time... and that the WHO said as much, too.)