
FDA issues first emergency use authorization for point-of-care diagnostic - doener
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-first-emergency-use-authorization-point-care-diagnostic
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js2
This is the device - [http://www.cepheid.com/en_US/systems/GeneXpert-Family-
of-Sys...](http://www.cepheid.com/en_US/systems/GeneXpert-Family-of-
Systems/GeneXpert-Xpress)

Brochure (pdf) - [https://p.widencdn.net/jdgicj/Cepheid-GeneXpert-Xpress-
Syste...](https://p.widencdn.net/jdgicj/Cepheid-GeneXpert-Xpress-System-
Brochure-US-IVD-0688-English)

Promo video -
[https://www.youtube.com/watch?v=lPTHRqDyWC4](https://www.youtube.com/watch?v=lPTHRqDyWC4)

About the size of a small laser printer.

I'm not clear how it returns results so quickly. I thought that the RT-PCR
process required numerous heating and cooling cycles which is what makes it
take as long as it does.

~~~
milksteak42
It's worth nothing that this machine is very low throughput - the larger one
only takes 4 samples and you have to use their proprietary disposable
cartridges.

edit: as pointed out below - the largest of the machines has 80 slots and
could probably do 2000/day taking around 45min-1hr/test all in

Contrast that with a modern real-time PCR machine which typically has capacity
for 96 samples, with some machines able to test 384 or even 1536 at a time.
The tradeoff is that those machines take 2-3 hours and the lab needs to do
nucleic acid extraction separately.

The main advantage of this machine is that it does the nucleic acid extraction
and PCR in one cartridge and in ~20 minutes. It's great for clinics and field
hospitals but for an established laboratory running hundreds or thousands of
tests per day, I'd wager that the standard methods are much cheaper and a bit
faster overall.

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mkagenius
What is the false positive rates of this, if 10k people are tested everyday,
can we expect 100 false positive everyday?

~~~
vikramkr
PCR tends to have pretty low false positive rates if used properly - so from a
technology perspective the contribution to that would be low. Although, if
they're using more innovative PCR methods, maybe there's a risk.

Where I think there's room for them to introduce false positive rates (that we
would not know without having access to proprietary information) is in how
they design something called a primer sequence. this is a little bit of DNA
that will go and find to a different little bit of DNA that's part of a larger
bit of DNA. Basically it lets you target it a little bit of DNA within a
larger bit of DNA. you want to make this primer so that it only will bind to
coronavirus DNA but will not bind to any other DNA. It's important to design
it that way because in PCR the DNA that amplifies to give you the signal is
whatever that primer was able to bind it to.

If you accidentally make a primer that can bind to some non coronavirus DNA
(something we call off Target binding) then you would end up with false
positives. There are bioinformatics tools to evaluate this and presumably the
FDA and the company did some work into making sure they didn't make any
mistakes when designing that, but that's what I think of first when it comes
to false positives.

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btbuildem
If this works, it should be open-sourced so it can be manufactured and
distributed at multiple locations, in many countries at once.

~~~
pen2l
I don't think that's going to work because this is a fairly complicated
machine, and the company itself which has experience building molecular
testing equipment and has a manufacturing supply chain in place is one of the
only few that can build this.

Also asking them to open-source their technology seems unfair, they're
entitled to their share of pay for their hard work. The average engineer at
this company probably makes much less than the average engineer at your FAANG
company.

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adrianN
Save lives first, think about compensation after the pandemic is dealt with.

~~~
roenxi
What - are they couriering the money from a secure vault in Germany by barge,
horse and carriage? I think not. It'd take a day or so to negotiate and then a
few hours of banking transfers. Governments around the world are currently
engaging in multi-billion to potentially multi-trillion dollar emergency
spending programs. There is room for negotiation and cash up front while the
company holds all the cards.

It isn't a good idea to fight economics in this crisis; beyond cushioning
people in the very short term against quarantines. It will leave everyone in a
very uncomfortable place if the incentives push individuals to avoid helping
in the next crisis. Or worse; avoiding the entire field. The problem with all
these 'experts should give away this lifesaving X for free' ideas is that then
only an idiot would try to become a medical expert - anyone smart would try to
go to Wall Street where they are allowed to make crazy profits.

The people working on this stuff are doing an insane amount of good. If there
aren't a few billionaires minted in the medical community out of this
something has gone terribly wrong - the incentives aren't there to guide
resources towards preparedness.

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hellofunk
Is this a different test than the 20-minute antibody test discussed here a
couple days ago?

~~~
wmf
Yes, it's completely different. That one is a blood test that only detects
infections that are pretty far along.

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rootusrootus
Would it detect resolved infections?

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el_benhameen
Yes, with an outer bound of however long antibodies against the disease
persist. That's the big value in that test.

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vanniv
FDA is remarkably quick to authorize things like this test that will make the
epidemic look worse, and yet are somehow utterly unwilling to consider
authorizing the treatments that have been shown to be effective.

I wonder why that is

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AlexCoventry
How accurate is it?

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neom
Is this what Theranos was trying to do? (sorry, I'm a n00b!)

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wmf
If you mean a machine to automate medical tests, yes. But there are plenty of
companies that already make such machines. If you mean a machine to run every
possible test using only a few drops of blood, no.

~~~
neom
Ah, thanks! I didn't realize Theranos was trying to do 240 tests on one
device.

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ck2
Where are the 5000/day (hour?) machines doing it for $1 a test?

This was promised weeks ago. It was a matter of automated diagnostic
reprogramming?

So this is promised in 10 days. How many units, 15000?

~~~
mlyle
> Where are the 5000/day (hour?) machines doing it for $1 a test?

This fills a different need. Rosch has their tests to market and test quantity
is ramping up at designated centers. $1/test is just what Rosch gets, so it's
gonna cost more than that.

> It was a matter of automated diagnostic reprogramming?

Nah, you still need reagents.

> So this is promised in 10 days. How many units, 15000?

The Cepheid machines are neat. They make bigger machines, but mostly you buy a
machine with 1-8 slots and disposable testing cartridges. When a patient needs
a test, you put their sample in the cartridge, stick it in a slot, and that
slot yields an answer in 45 minutes.

This will be a very nice tool for individual, smaller hospitals (and even
large clinics) to have in the next 10 days when it rolls out, and for
situations where we want to get immediate feedback. Probably not a _massive_
number of units at first. And not nearly as cost-effective as the Rosch.

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gojomo
I dream that in post-crisis clarity, some news sources will reverse the
traditional "FDA as protagonist" wording of such headlines, and instead prefer
formulations like:

"FDA removes threats of fines & imprisonment for one company's point-of-care
COVID-19 diagnostic"

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CPLX
How would that help improve people’s understanding of this issue?

~~~
jdavis703
It’s the same reason certain folks insist automatic income tax payment schemes
would cause people to forget about tax policy.

