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FDA grants Roche coronavirus test emergency green light within 24 hours (fiercebiotech.com)
348 points by elorant on March 14, 2020 | hide | past | favorite | 139 comments



Further information from a German paper:

- 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.


> Roche is pretty much the only manufacturer for machines like these.

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.



Yes, these machines are insane. See also

https://www.youtube.com/watch?v=6P-jaC3_d3o

The dramatic trailer music is quite adequate, IMHO.


That is a very well produced video, it doesn't contain a single spoken word and yet it tells the story perfectly. Incredible machinery. Any idea what these cost?


Looks like around 400k base [0], but a full system with service appears like it would run over a million in a year or two

[0] https://www.gsaadvantage.gov/ref_text/V797P7347A/0UZLK9.3QPY... , page 13


This is actually surprisingly cheap. My guess is the real margin is in the tests itself, which you must buy from Roche as well.


Yes, and if you install one on site, they send dedicated techs to set it up, which lasts a month or more, plus custom integration with site software. I worked with a similar machine and if it lost its net connection to the backend database, it would dump half a million $ in reagents down the drain when it entered "safe mode".


That is amazingly cheap, I expected an order of magnitude more.


The video above (at least one of them) was showing an entire automation line built on Roche technology-- easily an order of magnitude more than 400k. The Cobas 8800 is just a component of that entire line.


Ah ok, that makes more sense. I figured a 100K or so per unit would be cheap the way it has been engineered. That's a whole robotic laboratory and what with the normal price of cleanroom equipment it would be ridiculously cheap if that setup was a few hundred K.


Impressive video and soundtrack, indeed. One thing that I don't fully understand, though, is how relevant lab results might be accurate, when, during part of the processing workflow, containers appear to be open to the processing chamber and its atmosphere, thereby presumably being exposed to potential cross-contamination. I'm likely missing something trivial, so I'm curious about what it might be.


I guess it might be flushed by cleaned air or nitrogen ?

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.


I worked on the ancestor to these machines over at Abbott. There’s nothing in whole blood or serum that will spontaneously aerosolize and get into the air.

The tests are detecting levels of antigens, antibodies, or DNA in the sample. The samples are manipulated with disposable parts to prevent crossover.


Understood. Thank you very much for your clarifications.


Thank you for your feedback. Perhaps, you're right. Let's see whether other people can shed some additional light on this.


Like something from Star Trek


Glorious. :)


That is not huge - in fact that looks like there's an incredible amount of miniaturization already put into that product.

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.


Given the throughout, it’s actually quite amazing!


Researching the automated MDx market, I found out the Cobas 8800 (and indeed, pretty much all automated MDx solutions) only works with Roche-manufactured proprietary panels, or results are only valid with proprietary panels. BD lets you run user-originated panels, but you can mix them with FDA-approved panels. I can't just take some master mix from someone else and generate a valid result on a Cobas 8800, as far as I can tell. Would appreciate any clarification/correction on this, though.

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.


Considering this is HN, there is enough engineering brainpower to build open source clones of this. Biology is not the same as electronics, it is closer to software in the sense that a lot of things can be easily (for some definition of easy) cloned once you figure out how it works. The only difference is that biology is slow and expensive and takes a lot of equipment.

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.


I think you greatly underestimate how complicated these machines are. For instance, I just cannot imagine how these machines keep themselves so clean. My guess is "lots of disposables" but still, that must take years to get right. Just read "Bad Blood" to see how Theranos struggled with the machines not simply becoming a bloody mess, and they had some great engineers on the team.


Look at the FDA testing protocol [1] for their Covid-19 test kit.

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.

[1] https://www.fda.gov/media/134922/download


The lion's share of the test volume is done by commercial labs like LabCorp and Quest, who don't care that much about designing their own tests, they just want to maximize patient volume.

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."


It's mostly a commercial decision. Reagents have very high margins and recurring revenue is more attractive than large one-time purchases. Illumina does this with genetic sequencing as well.

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.


The Hologic Panther Fusion is another automated open platform.

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.


These folks [1] are working on an open Covid-19 test. There is a pretty significant logistical train that I haven't seen systematically addressed yet in the project, though lots of those pieces have open projects that can be picked up, adapted and integrated. Even failing will be valuable: that identifies gaps to address.

[1] https://app.jogl.io/project/118#about


That's much more impressive than the machine the CDC approved test was developed for:

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've done IT for labs. The PCs these insanely expensive machines are hoked to make me absolutely sick with how they have to be set up. You have a testing machine, be it a mass spec, PCR, whatever, costing 6 and 7 figures with a $500 PC that has every imaginable security hole and updates turned off. Drives me bonkers.


That PC is only for controlling this machine and no need to be on internet, right? If so, just config the windows firewall to disconnect it from the internet?

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.


Except you need them on the local LAN to share data, and you need them to have internet access through the local LAN so the vendor can log in remotely for maintenance and troubleshooting.


Pcr machines definitely not in 6 figures, unless they are enormous in sample numbers


I'm no tlimiting my statement to just PCRs, I'm saying all the crazy expensive lab machines that can be that expensive.


Am I missing something? The Roche website says

   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.
(24 / 8) * 960 = 2,880 per day

Update: formatting


It looks like that the 960 number is predicated upon a start time from "idle", and minimal interactions. The actual slope rate of test completion looks like it's 192/hour. If that throughput can be maintained with more frequent interaction to keep the machine fed, it'd be 4.6k/day. https://www.dialog.roche.com/content/dam/dialog/owp/apac/Med...

That is, it takes time to "stuff the pipeline".

The cited number -- 4128 -- appears to be 21.5 * 192.


I think the sample handling part is faster than the PCR part, but you might have more than 1 PCR part setup on the machine.

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.


This South Korean manufacturer seems to able to do 94 tests at a time in four hours with their machine. Which might be a nicer batch number for testing closer to the point of care.

https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-...


I think this is similar to what everybody else is doing -- using a thermocycler to run PCR. It can run 96 samples in parallel and takes 3-4 hours to run through 30-40 cycles. But there are a lot of manual steps, and I'm not sure how much the SK company automates them.


The article talks about a robot arm pipetting and implies the machine finishes the test, but I don't know what other steps there might be.


>I think this is similar to what everybody else is doing -- using a thermocycler to run PCR

What method do you propose without a thermocycler?


This can't be the only option for testing. Korea has tested hundreds of thousands of people so far. By far the largest number of any country, including China. Such high throughput does not seem achievable with these machines unless you already have a ton of them, and all the reagents are stockpiled.

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.


SK does 10.000 tests per day with test kits which they could quickly produce but which involve a lot of manual steps and hence man power. You could replace all that with 2.5 of these huge Roche machines. So for really high throughput you absolutely need those huge machines, everything else simply does not scale. Of course you need a stockpile of reagents, but manual test kits need these as well and AFAIK those are fairly standard.


How many machines are in the US?


There are 110 in the US (of either type; most are likely the 6800), and Roche says they've installed a "significant" number in the US in the last few weeks (who knows what that means).

https://thehill.com/policy/healthcare/other/487393-fda-grant...


These are hardly the only machines that can run rtPCR though; they're just highly automated.

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.


Who is going to supply you the primer for that kind of volume? :)


Roche ramped up production in anticipation of approval, so hopefully they can.


Dozens of labs came up with diagnostic tests in February, but the FDA+CDC placed huge bureaucratic roadblocks.

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.


Are there signs of favoritism towards Roche?


Probably big corp has dedicated teams that handle the complex paper works / processes needed for FDA approval.


I wish they would say test 50000 people completely at random in one of the hot spots and check out the real number of cases for 1000 people instead of this "you get tested if you have symptoms". I feel we're being deceived about the actual rate of death and how widespread it really is.


The reason for targeted testing is that everybody has limited testing capability. If we could wave a magic wand and instantly test tens of thousands of people, I’m sure we would.

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.


The test kits from SK cannot be used because of supply, approval and logistical issues. So each country pretty much need to get them made in their own countries because of red tape


Not just red tape. The advantage of this test is that it can be run on testing machines that US labs already have, which obviously isn't the case for something designed to run on South Korean machines.


I assure you, the machinery is pretty damn standard on the whole Earth.


I imagine US machinery being nonstandard with the rest of the world, given the imperial units


Basically anything even vaguely scientific in the US still uses metric units.


Anything vaguely engineering in the US uses imperial, pounds and decimal-inches everywhere.


I think it varies from field to field.

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.


At NASA the standard seem to be SI units for anything in space and Freedom (English) units for anything inside the atmosphere. It is bizarre.

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.


likely because aviation is still on ft and nautical miles worldwide, i would think


The choice of units to display to the pilot (feet vs metres, nautical miles vs kilometres, etc) doesn't have any necessary connection with the choice of units for engineering drawings, engineering calculations (e.g. calculating forces on various components during flight), etc. You could keep the former in non-metric and do the later in metric.

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.


As someone who worked in health R&D in the US, I can assure you it’s all metric and has been for decades.


Microscopes and optical tables in the US use mixed units. For example, you will often get a product marketed "25.4mm" which is 1 inch. Frequently a single optical table will mix components between imperial and metric.

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).


This machinery is made by a global company based in Switzerland, not the US


Oh come on scientists, doctors, engineers all mostly use Metric units and are quite capable of converting units. It's basic math. There's no reason we wouldn't have the same machines.


No, it will all be metric.


Some South Korean tests do run on standard machines. See https://news.ycombinator.com/item?id=22571551.


These people made the UK national news (channel four) with their claimed simple test kit. After three days it detects antibodies supposedly. https://www.biopanda.co.uk/php/products/rapid/infectious_dis...


How do you assemble false positive false negative statistics for a new diagnostic in the presence of exponential growth ...?

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 ...


Retest negatives and positives as random samples from both pools. Differential shows which has higher tendency to falsity. Continue as volumes of test rise. Track.


What would testing easily available for all mean for the control of the disease? When vaccines or even treatment is still a while away, could this help?

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?


RTPCR has way too high of a false negative rate to do anything of the sort. It's about 70% sensitive on a nasal swab of symptomatic patients-- in other words 30% false negative rate. Asymptomatic patients may have even a lower sensitivity.

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.


Isn't this why they run tests twice?


There are patients that are even negative on multiple test runs. Each measurement is not an independent measurement. We can't really solve this problem by testing multiple times, even if the measurements are spread in 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.


Food for though: if you are asymptomatic and test positive, you self-isolate as to not spread the disease further. Same for when you are symptomatic but not showing symptoms yet. Point is to change the behavior of the individual.


You can test someone, find they are clear, and the next day they get infected. You’d have to re-test people on a daily basis.


Yes you don’t test to prove people uninfected but to find those infected without symptoms so they self quarantine. The people crowding bars in NYC right now probably would have stayed home if they knew they were infected. You might also be able to use the stats to identify hotspots where a temporary lockdown or travel restrictions can make sense.


All government decisions, quick or slow, are driven by self interest


[flagged]


Roche is a Swiss company [0]. My neighbor here in Canton Zürich works at a lab that uses these machines. She's been testing coronavirus, and she's having to go in on Saturdays now to deal with the backlog. Not Sundays though. Labor on Sundays cost an arm and a leg in Switzerland.

[0] https://en.m.wikipedia.org/wiki/Hoffmann-La_Roche


If I had those skills I'd volunteer.


This isn't even the same thing. Roche Cobas machines are industrial scale equipment used at hospitals to identify pathogens.

If a hospital is equipped with a Cobas and they have a Cobas test reagent/plan for a given virus, they can automate the testing process.

Other vendors in this space are doing the same thing. Abbott, Siemens, Biomerieux, etc. These companies are the backbone of clinical labs, not just in the US but globally.


Assuming the WHO stash has not already been depleted due to the global spike in cases, the number of WHO tests available to the US is probably insufficient to be helpful for its over 300 million people. Incentivizing the private sector to create tests on the other hand does have the potential to get enough tests for the whole population.

This is a global pandemic and there are many other affected countries around the world that do not have the ability to ramp up testing production the way the US does. Poorer countries should be the ones with access to the emergency test kits, not the US.


I think the existing kits are performed by hand. This new one can be done using high-throughput machines.


I thought the WHO kits are being used in mass in South Korea and Italy. Is the U.S. really developing something unique?


There are many RT-PCR LDTs. It does not take very much to create a real-time RT-PCR LDT for COVID-19; two weeks ago the CDC posted a comprehensive description of the process on their website, but it was not a secret before then. All you need is a clinical-grade RT-PCR machine, synthesized primer/probe DNA (which many labs are equipped to do), and quality reagents.

The difference here is that the Roche instrument is pre-approved for clinical use both (1) in the US and (2) outside "high complexity" CLIA labs; the instrument is already widely deployed to hospital labs; and the instrument is highly automated compared to the basic 96-well RT-PCR machine, with a robotic stage that allows it to run thousands of samples per day with less manual work.

The WHO does not have a massive stockpile of complete test kits, and to my knowledge the countries that have scaled up testing are not relying on the WHO for anything but information. Any kits the WHO provides would need to run on an existing RT-PCR machine anyway.


CDC's test instructions and (more importantly) the target RNA/DNA sequences were posted more like 6 weeks ago -- I think I first noticed them in early February, around the time CDC announced that they had applied for an emergency use waiver from the FDA.

They've been revised considerably since then (with a big "research use only" warning on them added).


Their protocol for clinical labs is a superset of the research protocol. (Clinical labs also have extensive prior experience in this kind of protocol, and many state DPH and other labs are in continuous touch with the CDC through CDC's lab network.)


At least one company in South Korea, Seegene, has produced many tests and it is this aggressive private sector production that is largely reasonable for South Korea's effective testing. There is also a large demand for Seegene's tests around the world indicating that WHO tests are definitely not in sufficient supply.

The private sector stepping in is the best way to get enough tests out to everyone who needs them.

https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-...


4 SK companies: https://news.ycombinator.com/item?id=22572121

See rest of that thread for background - maybe Seegene is doing better PR?


I read about 80% of the tests in S. Korea are done with Seegene test kits.


This is March 1st press conference from South Korea: https://news.v.daum.net/v/20200301162614985. It says Seegene accounts for 37.8% of test volume. The context is that Seegene (and only Seegene, other companies have other supply chains) had supply chain problem. As I understand problem is now resolved.


It is different than the test currently being used in the US, at least. It is going to speed up testing rates.

See: https://youtu.be/q_WM_pMp0Hg?t=7382


I have no clue about this, but to me it seems they just took the existing human workflow and built a robot to replicate it. Is there no more clean slate way of doing this (maybe with a lot of pipes like in a refinery?). How does one even keep one of those monsters clean?


The WHO is a coordination organization. They don't do health policy directly. And FWIW: Roche is a Swiss multinational.

This test is probably good. It's certainly good that it got rapid approval and reflects the fact that the US executive branch has turned the corner and is now taking things seriously (seven weeks later than it should have, but at this point recriminations will have to wait -- we have more serious problems).

Whether more testing should have been available much earlier (obviously it should have) isn't really relevant to this particular test product.


PCR and high-throughput are two things, testing kits are for PCR and aren't very accurate.


Roche says the machines that these tests run "automate the preparation and analysis of samples for quantitative and qualitative nucleic acid testing using real-time PCR technology. "

https://www.dialog.roche.com/pk/en_us/products_and_solutions...


Um, what? What is inaccurate about the PCR?


"Recent research found that the sensitivity of CT for COVID-19 infection was 98% compared to RT-PCR sensitivity of 71%."

https://www.sciencedaily.com/releases/2020/02/200226151951.h...

And this comment from a prior thread: https://news.ycombinator.com/item?id=22571588


Please read the sources you linked to. The problem is the disease model and how the disease presents itself, how and where the samples are taken, etc. The PCR test is not what is the problem. Its the gold standard. We use it daily at our company and rely on it for our vaccine development. Don't believe me, ask any scientist.

Also, a minor point but I don't get the idea of replying to someone with someone else's opinion. That way I can't really respond to you can I? I'm supposed to find the original person and reply to them? .. Sorry.. just a pet peeve.


Being trying to figure out how many of these machines are deployed in the U.S.


their machine is fascinating but something I learned about with all the talk about tests is this one that scans for 21 illnesses in one test, they had been using it to eliminate most everything else and imply covid19

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)


> if the president had just accepted WHO kits instead of refusing them for US profit

I haven't followed this very closely, so my impression was that that was the CDC's decision/regulation - is that not the case?


The president is in charge of the CDC.


The President appoints certain people within the CDC and can make budget recommendations (although the budget is ultimately set by Congress).

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.


We are in one of those classic scenarios where it's not clear if you should congratulate them on taking the right action or put their head on a pike for doing it too slowly.


Personally while it was a bit painful watching Trump (try to) speak in his typical style yesterday, I thought it was extremely compelling to see the lineup of CEOs from Walmart, Walgreens, CVS, Quest, Labcorp, Roche, etc. each of them announcing their support and dedication to serving their communities and fighting COVID.

“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.


I don't understand all the negativity and downvotes around Trump's actions.

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.


This is the same surgeon general that was saying we should limit testing to people with symptoms


We also at the time had a severe shortage of tests. If you have enough tests, sure test everyone. If you only have a couple, then your hands are basically tied. What do you do when you use all your available test kits on people that come back negative and then a real case shows up?


He was saying this in Baton Rouge on Thursday.


Probably due to statements like "we'll have a vaccine in two weeks", "some people go to work and they get better", "foreign virus", "our numbers will go to zero", "I don't want that cruise ship docking and making our numbers go up", "Google have 1,700 developers on a Coronavirus website", etc.


>I don't understand all the negativity and downvotes around Trump's actions.

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."



The commercially available BioFire panel tests for regular coronavirus, NOT SARS-CoV-2 (the virus responsible for Covid-19). They may have something in the works. that said, these machines are not very high throughput; more of a point of care test for small/medium hospitals.


Ah, that's a clever workaround.


> 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

No. Refusing them because of US government red tape and bureaucracy.


Roche is also a Swiss company, it’s not even American.

~~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


The name came from a Roche-owned lab subsidiary that later merged with another big company from California - Roche retained a 49.9% stake in the new company.

Roche sold their stake in 2002.


Well Genentech in SanFrancisco is large, and part of Roche too.


Why wasn't this developed in January when the need was clear?


Development is not necessarily the hardest part. You are developing a medical device that needs to be validated. Even with expedited approvals this is a huge undertaking where only a limited amount of people can be involved at the same time.


It probably wasn't developed overnight; it was just approved quickly.


It wasn’t a national emergency in Jan. WHO had also not declared it a pandemic yet.


Half the problem was a lack of tests, you can't declare a pandemic until people have tested positive so waiting for that is rather self-defeating.


The WHO did declare it a “Global Health Emergency” in January: https://www.bbc.com/news/av/world-51319967/coronavirus-decla...

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.


@glitchc is right though! He said “national emergency” and in January the only nation impacted was China ;)

(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.)


Everyone serious knew it was coming in January. Once it's declared a pandemic, it's already arrived. People have to stop pretending that "no one could have known". Everybody knew. We were all yelling about it at the time.


We have to wait for evidence (numbers) before declaring it a pandemic. Cooler heads must prevail. Plus, Roche would not have been able to obtain a 24 hour approval turnaround without the official declaration of emergency.


You mentioned the lack of a declared pandemic in response to a statement that the need for tests was clear in January. Now you mention the need for "numbers" (i.e., positive tests) in the same context. I think you're getting it backwards. A widely available test was essential for establishing that it was a pandemic. We all need to keep cool heads, but we don't need to make excuses or pretend that the lack of tests in the U.S. was the result of prudence and good sense. We could have responded faster. Our national policy isn't dictated by the WHO. It was a failure. If waiting for the WHO to declare a pandemic held back our response, we shouldn't have waited. If we needed a national emergency declared earlier in order to respond correctly, we should have declared it.


Damn, you must have made billions on the stock market since you already knew in January what was gonna happen.


Why are people like this? Everyone knew more testing (the subject at hand) was needed. The second the first case was detected in the US (January 22) there was instant coverage of the inability of people in Seattle to get tests. And there were no tests. And there remained no tests. And only now, as the US clusters have started to spread out of control, are we seeing a significant acceleration in test availability (c.f. the linked article, about quick approval for a new test mechanism). And we know this wasn't impossible, because many nations (South Korea, Taiwan, Japan) got this right and managed extensive testing.

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.


The State of Oregon lab can process 80 samples a day. Every person gets at least 2 samples taken. They are waiting on >150 samples to be tested...


Billions is a high ask; almost nobody has the kinds of capital needed to do that, and even for those that do, a highly levered bet that hundreds of thousands of people are going to die is pretty slimy. Lots of people (including me) did sell substantial amounts of stock before mid-February to ensure we have money available.


If you sold before February you were also betting that people were going to die. What makes your actions less slimy?


I guess you're getting downvoted because of your tone, but I think you're essentially right. selling off a bunch of stock in expectation of a looming crisis is a choice that leaves your buyers holding the bag when it strikes. it's not fundamentally different than using leverage, options, or whatever exotic investment tool you fancy. people ascribe an arbitrary moral difference between selling to prevent losses and more active investing to seek a profit. in both cases people are making a bet on the outcome of an uncertain event. some will win and some will lose.

regardless, moves made by a small private investor don't really matter in the grand scheme of things. just don't panic sell.


> you must have made billions on the stock market

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.


Not everyone is living for the profits




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