
FDA grants Roche coronavirus test emergency green light within 24 hours - elorant
https://www.fiercebiotech.com/medtech/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...](https://www.dialog.roche.com/pk/en_us/products_and_solutions/molecular-
lab/cobas-6800-8800-systems.html)

\- 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...](https://www.faz.net/2.1690/pharmakonzern-roche-neuer-schnelltest-
fuer-coronavirus-16678244.html)

EDIT: More exact numbers in the linked article: Cobas 6800 can do 1440
tests/day, Cobas 8800 4128 tests/day.

~~~
neom
The cobas 8000 is huge:
[https://www.youtube.com/watch?v=Aht-L4BMyN4](https://www.youtube.com/watch?v=Aht-L4BMyN4)

~~~
deng
Yes, these machines are insane. See also

[https://www.youtube.com/watch?v=6P-jaC3_d3o](https://www.youtube.com/watch?v=6P-jaC3_d3o)

The dramatic trailer music is quite adequate, IMHO.

~~~
jacquesm
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
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...](https://www.gsaadvantage.gov/ref_text/V797P7347A/0UZLK9.3QPYM1_V797P-7347A_V797P7347A.PDF)
, page 13

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

~~~
nkrumm
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.

~~~
jacquesm
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.

------
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...](https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-
testing-us-so-delayed/607954/)

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?

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

------
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.

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

~~~
8note
I imagine US machinery being nonstandard with the rest of the world, given the
imperial units

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

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

~~~
skissane
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
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.

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

~~~
skissane
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.

------
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...](https://www.biopanda.co.uk/php/products/rapid/infectious_diseases/covid19.php)

------
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.

~~~
YZF
Isn't this why they run tests twice?

~~~
mlyle
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 __.

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

------
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...](https://www.biofiredx.com/products/the-filmarray-
panels/filmarrayrp/)

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?

~~~
toomim
The president is in charge of the CDC.

~~~
zaroth
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
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
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
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.

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

~~~
war1025
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
He was saying this in Baton Rouge on Thursday.

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

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

~~~
ajross
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.

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

~~~
ajross
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
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...

