FDA grants Roche coronavirus test emergency green light within 24 hours

[deng]

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.

[mlyle]

> 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.

[neom]

The cobas 8000 is huge: https://www.youtube.com/watch?v=Aht-L4BMyN4

[yourapostasy]

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.

[js2]

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)

[eddieh]

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

[dv_dt]

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-...

[m0zg]

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.

[fblp]

How many machines are in the US?

[peter303]

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.

[joncrane]

Are there signs of favoritism towards Roche?

[stjohnswarts]

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.

[simonh]

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.

[m3kw9]

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]

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.

[gandalfian]

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...

[breatheoften]

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 ...

[ggm]

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.

[alkonaut]

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?

[mlyle]

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.

[bosie]

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.

[simonh]

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.

[Proven]

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

[cjslep]

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

[chapium]

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.

[tic_tac]

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.

[roywiggins]

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

[ajross]

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.

[balola]

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

[mocana]

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

[ck2]

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)

[champagneben]

> 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?

[nkrumm]

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.

[EdgarVerona]

Ah, that's a clever workaround.

[3fe9a03ccd14ca5]

> 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.

[wbl]

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

[gotstad]

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.

[mattkrause]

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

[glitchc]

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