[HN Gopher] FDA grants Roche coronavirus test emergency green li...
___________________________________________________________________
FDA grants Roche coronavirus test emergency green light within 24
hours
Author : elorant
Score : 247 points
Date : 2020-03-14 14:47 UTC (8 hours ago)
(HTM) web link (www.fiercebiotech.com)
(TXT) w3m dump (www.fiercebiotech.com)
| mocana wrote:
| Being trying to figure out how many of these machines are
| deployed in the U.S.
| m3kw9 wrote:
| 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
| makomk wrote:
| 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.
| emilfihlman wrote:
| I assure you, the machinery is pretty damn standard on the
| whole Earth.
| 8note wrote:
| I imagine US machinery being nonstandard with the rest of
| the world, given the imperial units
| s1artibartfast wrote:
| This machinery is made by a global company based in
| Switzerland, not the US
| mrosett wrote:
| Basically anything even vaguely scientific in the US
| still uses metric units.
| starpilot wrote:
| Anything vaguely engineering in the US uses imperial,
| pounds and decimal-inches everywhere.
| skissane wrote:
| 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.
| Ottolay wrote:
| 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.
| jacquesm wrote:
| No, it will all be metric.
| breatheoften wrote:
| 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 ...
| deng wrote:
| 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.
| fblp wrote:
| How many machines are in the US?
| x0x0 wrote:
| 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.
| ksk wrote:
| Who is going to supply you the primer for that kind of
| volume? :)
| inferiorhuman wrote:
| Roche ramped up production in anticipation of approval,
| so hopefully they can.
| adventured wrote:
| 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...
| eddieh wrote:
| Am I missing something? The Roche website says
| Designed to provide a fully integrated real-time PCR workflow,
| the cobas(r) 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
| maxerickson wrote:
| 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.
| mlyle wrote:
| 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.
| dv_dt wrote:
| 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-...
| gniv wrote:
| 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.
| ksk wrote:
| >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?
| mlyle wrote:
| > 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.
| m0zg wrote:
| 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.
| deng wrote:
| 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.
| neom wrote:
| The cobas 8000 is huge:
| https://www.youtube.com/watch?v=Aht-L4BMyN4
| 3fe9a03ccd14ca5 wrote:
| Given the throughout, it's actually quite amazing!
| barkingcat wrote:
| 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.
| deng wrote:
| Yes, these machines are insane. See also
|
| https://www.youtube.com/watch?v=6P-jaC3_d3o
|
| The dramatic trailer music is quite adequate, IMHO.
| ape4 wrote:
| Like something from Star Trek
| atomi wrote:
| Glorious. :)
| jacquesm wrote:
| 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?
| alextheparrot wrote:
| 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/0UZL
| K9.3QPY... , page 13
| jacquesm wrote:
| That is amazingly cheap, I expected an order of magnitude
| more.
| [deleted]
| nkrumm wrote:
| 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.
| deng wrote:
| This is actually surprisingly cheap. My guess is the real
| margin is in the tests itself, which you must buy from
| Roche as well.
| yourapostasy wrote:
| 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.
| ampdepolymerase wrote:
| 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.
| yourapostasy wrote:
| 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
| deng wrote:
| 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.
| yourapostasy wrote:
| 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
| nkrumm wrote:
| 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.
| milksteak42 wrote:
| 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.
| ck2 wrote:
| 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)
| 3fe9a03ccd14ca5 wrote:
| > _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.
| dmix wrote:
| 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
| polotics wrote:
| Well Genentech in SanFrancisco is large, and part of Roche
| too.
| CptFribble wrote:
| 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.
| EdgarVerona wrote:
| Ah, that's a clever workaround.
| nkrumm wrote:
| 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.
| champagneben wrote:
| > 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?
| toomim wrote:
| The president is in charge of the CDC.
| zaroth wrote:
| 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.
| whatshisface wrote:
| 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.
| zaroth wrote:
| 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.
| war1025 wrote:
| 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.
| lozenge wrote:
| 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.
| selimthegrim wrote:
| This is the same surgeon general that was saying we
| should limit testing to people with symptoms
| war1025 wrote:
| 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?
| selimthegrim wrote:
| He was saying this in Baton Rouge on Thursday.
| stevenwoo wrote:
| There was an episode of Fresh Air last week that covered
| this. The way the administration has been run makes it so
| everyone that is a political appointee is making policy
| decisions based on Trump's non scientific views, including
| disbanding our pandemic national security team that could
| have redirected resources/efforts earlier from the top.
|
| https://www.npr.org/2020/03/12/814887953/how-trumps-
| mismanag...
|
| https://www.washingtonpost.com/outlook/nsc-pandemic-
| office-t...
| ceejayoz wrote:
| https://en.wikipedia.org/wiki/Buck_passing#%22The_buck_stops.
| ..
| alkonaut wrote:
| 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?
| abvdasker wrote:
| As I understand it, testing is mainly useful in the early
| stages of an outbreak so that effective quarantines can be
| established. If you can "find" the virus early, then you can
| still contain it and protect most of the population from being
| infected.
|
| That ship has sailed, at least in the US. There has been so
| little testing that the number of confirmed cases being
| reported are basically meaningless. So it's impossible to
| establish an effective quarantine because we have no idea how
| many people have it or geographically where the hot-spots are.
| The name of the game now is just to reduce the peak demand for
| care placed on hospitals to prevent the whole system from being
| overwhelmed, as it has been in Italy.
|
| Targeted testing is still useful, especially for healthcare
| professionals. Obviously they need to know if they've been
| infected to prevent their patients -- who are usually
| especially vulnerable due to age and comorbidity -- from being
| infected.
| mlyle wrote:
| 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.
| Proven wrote:
| All government decisions, quick or slow, are driven by self
| interest
| bradly wrote:
| I still don't understand this. Doesn't WHO already have emergency
| tests ready to use? Is this just big gov funneling money to U.S.
| corporations or is there a less pessimistic explanation?
| balola wrote:
| PCR and high-throughput are two things, testing kits are for
| PCR and aren't very accurate.
| bewaretheirs wrote:
| 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.
| ..
| ksk wrote:
| Um, what? What is inaccurate about the PCR?
| wideasleep1 wrote:
| "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
| cjslep wrote:
| Roche is a Swiss company [0]. My neighbor here in Canton Zurich
| 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
| jacquesm wrote:
| If I had those skills I'd volunteer.
| tic_tac wrote:
| 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.
| chapium wrote:
| 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.
| ajross wrote:
| 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.
| roywiggins wrote:
| I think the existing kits are performed by hand. This new one
| can be done using high-throughput machines.
| bradly wrote:
| I thought the WHO kits are being used in mass in South Korea
| and Italy. Is the U.S. really developing something unique?
| ak217 wrote:
| 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.
| bewaretheirs wrote:
| 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).
| ak217 wrote:
| 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.)
| tic_tac wrote:
| 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-...
| robocat wrote:
| 4 SK companies:
| https://news.ycombinator.com/item?id=22572121
|
| See rest of that thread for background - maybe Seegene is
| doing better PR?
| kube-system wrote:
| 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
| WanderPanda wrote:
| 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?
| wbl wrote:
| Why wasn't this developed in January when the need was clear?
| gotstad wrote:
| 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.
| glitchc wrote:
| It wasn't a national emergency in Jan. WHO had also not
| declared it a pandemic yet.
| ajross wrote:
| 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.
| glitchc wrote:
| 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.
| [deleted]
| dkarl wrote:
| 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.
| folli wrote:
| Damn, you must have made billions on the stock market since
| you already knew in January what was gonna happen.
| ajross wrote:
| 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.
| briffle wrote:
| 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...
| AriaMinaei wrote:
| > 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.
| 8note wrote:
| Not everyone is living for the profits
| SpicyLemonZest wrote:
| 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.
| esoterica wrote:
| If you sold before February you were also betting that
| people were going to die. What makes your actions less
| slimy?
| roywiggins wrote:
| 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.
| KarlKemp wrote:
| 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.
| ComputerGuru wrote:
| @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.)
| mattkrause wrote:
| It probably wasn't developed overnight; it was just approved
| quickly.
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