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FDA grants Roche coronavirus test emergency green light within 24 hours
- bradly 7y agoI 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?
- roywiggins 7y agoI think the existing kits are performed by hand. This new one can be done using high-throughput machines.
- bradly 7y agoI thought the WHO kits are being used in mass in South Korea and Italy. Is the U.S. really developing something unique?
- tic_tac 7y agoAt 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-testing-intl-hnk/index.html https://www.cnn.com/2020/03/12/asia/coronavirus-south-korea-...
- robocat 7y ago4 SK companies: https://news.ycombinator.com/item?id=22572121 https://news.ycombinator.com/item?id=22572121 See rest of that thread for background - maybe Seegene is doing better PR?
- dba7dba 7y agoI read about 80% of the tests in S. Korea are done with Seegene test kits.
- sanxiyn 7y agoThis is March 1st press conference from South Korea: https://news.v.daum.net/v/20200301162614985 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.
- kube-system 7y agoIt 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 https://youtu.be/q_WM_pMp0Hg?t=7382
- WanderPanda 7y agoI 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?
- ak217 7y agoThere 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 7y agoCDC'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 7y agoTheir 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 7y agoAssuming 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.
- balola 7y agoPCR and high-throughput are two things, testing kits are for PCR and aren't very accurate.
- bewaretheirs 7y agoRoche 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/molecular-lab/cobas-6800-8800-systems.html https://www.dialog.roche.com/pk/en_us/products_and_solutions...
- ksk 7y agoUm, what? What is inaccurate about the PCR?
- wideasleep1 7y ago"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.htm https://www.sciencedaily.com/releases/2020/02/200226151951.h... And this comment from a prior thread: https://news.ycombinator.com/item?id=22571588 https://news.ycombinator.com/item?id=22571588
- ksk 7y agoPlease 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.
- cjslep 7y agoRoche 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 https://en.m.wikipedia.org/wiki/Hoffmann-La_Roche
- jacquesm 7y agoIf I had those skills I'd volunteer.
- chapium 7y agoThis 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 7y agoThe 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.
- wbl 7y agoWhy wasn't this developed in January when the need was clear?
- glitchc 7y agoIt wasn’t a national emergency in Jan. WHO had also not declared it a pandemic yet.
- ajross 7y agoEveryone 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 7y agoWe 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 7y ago[deleted]
- dkarl 7y agoYou 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.
- deng 7y agoFurther 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/molecular-lab/cobas-6800-8800-systems.html 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-schnelltest-fuer-coronavirus-16678244.html 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.
- neom 7y agoThe cobas 8000 is huge: https://www.youtube.com/watch?v=Aht-L4BMyN4 https://www.youtube.com/watch?v=Aht-L4BMyN4
- deng 7y agoYes, 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.
- m3kw9 7y agoThe 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 7y agoNot 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 7y agoI assure you, the machinery is pretty damn standard on the whole Earth.
- 8note 7y agoI imagine US machinery being nonstandard with the rest of the world, given the imperial units
- jacquesm 7y agoNo, it will all be metric.
- s1artibartfast 7y agoThis machinery is made by a global company based in Switzerland, not the US
- mrosett 7y agoBasically anything even vaguely scientific in the US still uses metric units.
- starpilot 7y agoAnything vaguely engineering in the US uses imperial, pounds and decimal-inches everywhere.
- Proven 7y agoAll government decisions, quick or slow, are driven by self interest
- ck2 7y agotheir 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/filmarrayrp/ 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 7y ago> 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 7y agoRoche 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 7y agoWell Genentech in SanFrancisco is large, and part of Roche too.
- CptFribble 7y agoThe 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.
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- mocana 7y agoBeing trying to figure out how many of these machines are deployed in the U.S.
- alkonaut 7y agoWhat 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 7y agoRTPCR 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 7y agoIsn't this why they run tests twice?
- mlyle 7y agoThere 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.
- deleted 7y ago[deleted]
- bosie 7y agoFood 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.
- breatheoften 7y agoHow 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 7y agoRetest negatives and positives as random samples from both pools. Differential shows which has higher tendency to falsity. Continue as volumes of test rise. Track.
- peter303 7y agoDozens 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-coronavirus-testing-us-so-delayed/607954/ 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.
- gandalfian 7y agoThese 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_diseases/covid19.php https://www.biopanda.co.uk/php/products/rapid/infectious_dis...
- stjohnswarts 7y agoI 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 7y agoThe 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.