Please create an account to participate in the Slashdot moderation system

 


Forgot your password?
Close
typodupeerror
×
Medicine Biotech

US Regulators Quickly Approve Roche's New and Faster COVID-19 Test (ibtimes.com) 238

Posted by EditorDavid from the timely-testing dept.
schwit1 quotes the International Business Times: Swiss pharmaceutical giant Roche announced Friday it had received emergency approval from U.S. regulators for a new and much faster test for diagnosing the deadly new coronavirus...

The test can be run in high volumes on fully automated equipment, Roche said, suggesting it could provide more results far faster than other tests available. "We are increasing the speed definitely by a factor of 10," Thomas Schinecker, head of Roche's diagnostics unit, said in an interview with Bloomberg News. Widespread testing is essential in the race to rein in the spread of the virus, which has so far infected more than 130,000 people and killed nearly 5,000 worldwide. The new Roche tests, which will also now be available in markets that accept the European CE-mark certification, are run on Roche's widely available cobas 6800/8800 systems and can provide results within 3.5 hours, the company said.

In a 24-hour period, the largest machines can provide results on up to 4,128 tests, it said.
Fierce Biotech points out that "emergency use" of the test was quickly approved by U.S. regulators within 24 hours: In addition to the one-day approval, the FDA said it did not object to Roche pre-shipping its COVID-19 tests to laboratories ahead of time, so they could be used immediately following the authorization...

The test is designed to detect nucleic acid strands of the SARS-CoV-2 virus from nasal or oral swabs. However, the company said negative results do not preclude an infection and should be combined with clinical observations and the patient's history and contact with the disease...

"Roche is committed to delivering as many tests as possible and is going to the limits of our production capacity," the company said in a statement, and it expects to have millions of tests available per month.
This discussion has been archived. No new comments can be posted.

US Regulators Quickly Approve Roche's New and Faster COVID-19 Test More

US Regulators Quickly Approve Roche's New and Faster COVID-19 Test

Comments Filter:

  • Nothing like a crisis (Score:5, Insightful)

    by alvinrod ( 889928 ) on Saturday March 14, 2020 @07:36PM (#59831150)
    Nothing like a crisis to cut through the usual red tape of bureaucracy. The FDA could do us all a favor by doing this for more drugs and medical equipment approved for use in European and other modern industrialized nations because a lot of times that have better or less expensive options that U.S. citizens don't have access to because the companies either don't want or can't afford to jump through all the extra and generally needless sets of hoops.

    • Re:Nothing like a crisis (Score:5, Insightful)

      by Anonymous Coward on Saturday March 14, 2020 @07:46PM (#59831170)
      There is a reason the "hoops" are there. There is a small but non-zero possibility that by rushing these tests (or anything for that matter) through the approval process, something will be missed and the test will not be completely accurate or fail somehow in unanticipated ways. In this situation, it has been judged that the risk of that is acceptable given the potential benefit of being able to test for this new threat much more quickly, and so it was allowed to shortcut the normal process. In general though, the "hoops" are there for a reason, often hard-learned at some point in the past (even if the reasons are not obvious to people newer or unfamiliar with the process) and if you were to just "cut through the red tape" for everything with the bright idea that you are somehow doing everyone a favor, you doom us to have to re-learn those same lessons again.

      • Re: (Score:2)

        by tg123 ( 1409503 )

        The FDA could do us all a favor by doing this for more drugs and medical equipment approved for use in European and other modern industrialized nations...

        Yes the FDA needs to work with other countries regulators with a good example being what the FAA does with aircraft that are certfied overseas.

        At the moment all the FDA is doing is "Reinventing the Wheel" when a new drug or medical equipment comes out which is a waste of time and effort.
        This has very little safety benefits and really all it does is protect USA medical company's from overseas competition which artificially inflates prices for US patients and denies them access to the latest medical trea

    • Re:Nothing like a crisis (Score:5, Interesting)

      by frank_adrian314159 ( 469671 ) on Saturday March 14, 2020 @07:56PM (#59831190) Homepage

      Those hoops? That red tape? It's so we don't get Thalidomide [wikipedia.org] babies. Which would have been possible, had we had the same rules as the Europeans at that time.

      Note that this is not necessarily a defense of the rules WRT lab tests, which may be overly strict. However, having a multiplicity of rules for various things is usually a good thing overall, because it leads to a less brittle system, due to the reduction of common failure modes across heterogeneous sub-systems.

    • Re:Nothing like a crisis (Score:5, Informative)

      by Solandri ( 704621 ) on Saturday March 14, 2020 @07:56PM (#59831192)
      This. The problem dates back to the 1960s. The FDA kept thalidomide out of the U.S. market [wikipedia.org] when it was being distributed freely (even over the counter for a time) in Europe and Canada. When it was discovered to be the cause of crippling birth defects, the U.S. was spared because of the FDA's super-cautious attitude.

      Unfortunately, ever since then, the FDA has tried to err far too much on the side of caution. Resulting in higher prices, single suppliers who can exert monopoly pricing, and a lack of U.S. companies wishing to manufacture generic drugs because the hoops the FDA requires for them to be approved as a manufacturer makes manufacturing domestically more expensive than importing generics manufactured elsewhere.

    • Probably not (Score:5, Insightful)

      by rsilvergun ( 571051 ) on Saturday March 14, 2020 @09:11PM (#59831310)
      when we're not in a crisis mode it's not worth the risk. Shortcuts can cost lives, especially in medicine. But when you're in crisis mode you balance that risk. When you're _not_ in crisis mode you take things slower and have outsiders check the work. Otherwise you get stuff like those phony blood tests from Theranos.
    • Plenty of treatments that look good in vitro end up fatal in vivo, the red tape exists for a reason. Being able to bypass it is also an option for a reason.

      • Plenty of treatments that look good in vitro end up fatal in vivo, the red tape exists for a reason. Being able to bypass it is also an option for a reason.

        This is a test not a therapy or treatment. Faulty testing has negative real world cosequences for sure, but babies with flippers will not be one.

  • The Turkish government already said they had a 90 minute test weeks ago and they were working on a 75min one (https://www.google.com/amp/s/www.trtworld.com/turkey/turkish-doctors-develop-faster-coronavirus-test-kit-33885/amp) isn't this quite slow in comparison? ;)

    • if all you care about it how fast someone says they can test, these people say they can test in two minutes: https://www.9news.com/article/... [9news.com]

      • Antibody test. Not accurate for shit, especially early on. Useless until specific treatments are developed.

    • Re:Why not use the Turkish test? (Score:4, Informative)

      by Cyberax ( 705495 ) on Sunday March 15, 2020 @02:33AM (#59831712)
      You can shave off cycles from RTPCR by using high concentration of primers and using lower fluorescence threshold. You typically need around 20 cycles to reliably detect the presence of the DNA, and each cycle is around 10 minutes but can be shortened to about 5-6 mins if you don't care too much about accuracy. So 90 minutes is a bit of a stretch, but might be close enough for a simple high-throughput screening test.

  • If you have the machines.
    The US has 2.

    • A conflicting report. [bloomberg.com]

      The U.S. and much of Europe have been criticized for testing their populations too slowly, allowing the virus to proliferate. Roche’s cobas systems, launched in 2014, are widely available globally, with 695 of the 6800 instruments and 132 of the 8800 systems already installed. There are 110 of these tools in the U.S., and Roche has installed a “significant amount” of new ones in key locations in the U.S. in recent weeks, Schinecker said. Roche declined to specify how many of those units are 8800 and how many are 6800 models.

    • Re: (Score:3)

      by Cyberax ( 705495 )

      If you have the machines.

      You don't NEED anything special for the test. Any PCR machine (a thermocycler) would do just fine. There are PLENTY of them in hospital labs, they are routinely used to detect viral load of HIV or HEP C in patients on antiviral drugs (when antibodies become undetectable).

      The Roche system is simply an automated PCR machine with high batch capacity. There's nothing at all special about it.

  • But, Why? [serious] (Score:3, Insightful)

    by MrLogic17 ( 233498 ) on Saturday March 14, 2020 @08:44PM (#59831270) Journal

    Serious question - why bother testing?

    If you have any flu-like symptoms, you should already be staying home and dealing with proper hygiene.

    If you are positive for COVID-19, there is no treatment anyone can do beyond what a normal respiratory flu person would get.

    So, aside from gathering metrics on spread (which are of questionable use given how low testing rates are) - why?

    • Re:But, Why? [serious] (Score:5, Insightful)

      by burtosis ( 1124179 ) on Saturday March 14, 2020 @08:47PM (#59831278)
      Mass testing and tracing is effective because people are most contagious a few days before symptoms appear to a few days after. The time people most need to be in quarantine is when they feel 100% fine. This is the entire basis for containment effort after containment effort failing.

      • But testing isnt doing any of this.
        No country on the plant has prevented the spread, and testing is only going to identify people who have had it for days or a week.

        This all seems like media theater to make people feel like somethibg is being done.

        • Testing and isolation slows the spread so hospitals aren’t overwhelmed and so the population builds an immunity and a lower total % gets infected.

        • No country on the plant has prevented the spread,

          Oh really? What about China where new cases are down 99% from the peak? [wikipedia.org] Or South Korea where new cases are down 93% from the peak? [wikipedia.org]

        • Re: (Score:2)

          by AmiMoJo ( 196126 )

          Testing means that vulnerable people who it could kill get treatment earlier. It means that the spread of the disease can be more accurately tracked, helping with planning such as where lockdowns are needed.

          Testing also helps overcome human nature. When told to isolate for 2 weeks people will naturally think to themselves "I'm okay, it's just a cold or normal flu, I can carry on working or go out shopping." With a positive test it becomes much harder to deny the reality of the situation.

          Mass testing is real

      • CDC says if you are asymptomatic, it's unlikely you are contagious.
        • CDC says if you are asymptomatic, it's unlikely you are contagious.

          Despite most countries having strong evidence to the contrary.

          I sense a Trump reality distortion field at work.

    • Interesting that with all our amazing bio-tech technology the only real thing that we can do is minimize contacts, wash hands. 19th century approaches, but with 21st century travel.

      I like to read in the newspaper how far it has spread. But that really is about the only purpose of testing. And maybe to help slow the initial take up.

      • Rapid DNA vaccines and modernized vaccine manufacturing has been underfunded for a long time. We still use eggs in making flu vaccine. If we'd spent air craft carrier money on this tech and started testing a month ago we'd have been fine.
      • IF there was a test to say you are corona-virus immume - you had it and now have antibodies - you could travel, spend and go to concerts etc. Economy gets moving again. So yeah, unless we can give people an all areas pass, Trumps re-election will be toast. More security theater for oldies, because if the miss it before vaccine time, they will probably get it anyway. Millennials should resent this lockdown and pandering of senior citizens votes.

    • Trudeau's wife tested positive for Corvid-19. Trudeau stays home for a couple of weeks. Sensible to slow the peak.

      But should Trudeau kiss his wife? Or should he try to avoid the virus entirely?

      Once he gets it, he will be immune. Then he can ignore future contacts.

      Should health professionals try to get the virus now? Before the peak, while facilities are available to treat complications. Then be immune.

      Nobody talks about this.

      • You are assuming the virus doesn't mutate. If it does (and most viruses do), then getting the disease once is not necessarily any protection against getting it again in the future.

        A person who survived SARS in the early 2000s, or MERS a decade ago, is not immune to COVID-19.

      • Once he gets it, he will be immune.

        Nope. We've already had people who have "recovered" only to contract it again.
        It could be bi-phasic, but there's actually no indication that meaningful permanent (or long term) immunity is ever developed.

        • Once he gets it, he will be immune.

          Nope. We've already had people who have "recovered" only to contract it again.

          You have a link to some journals for that....?

      • He already has it, no test required.
        He does not need to kiss her. To be in the same room is enough.
        Corona virus, like flu and others, already spread by simply breathing, depending where the infection is.
        I don't need to sneeze at you to infect you, or shake hands. If you sit 20 minutes at my side in a bus or train or car, you get it ...

    • So that we can all stop working from home and send the kids back to school in a reasonable time frame.

    • Not much logic, Mr. Logic.

      If you have any flu-like symptoms, you should already be staying home and dealing with proper hygiene.
      You use proper hygiene to prevent infections, after wards it is kind of pointless. Why wash hands when you have the flu and stay at home?

      So, aside from gathering metrics on spread (which are of questionable use given how low testing rates are) - why? to get metrics and know if it is time to call for emergency measures.

      If you are positive for COVID-19, there is no treatment

    • Testing is useful because you can be positive but asymptomatic, and actively spreading the virus to vulnerable people.

  • Another in the pipe too, from Thermo Fisher (Score:5, Insightful)

    by Ungrounded Lightning ( 62228 ) on Saturday March 14, 2020 @09:18PM (#59831320) Journal

    At the emergency declaration press conference, where Trump announced the 24 hour approval of the Roche test, he said that there was another on this fast track.

    It's from Thermo Fisher. It's expected to be approved Monday and deploying within the week.

    The numbers he mentioned seemed to say the Roche machine will add about half a million tests per week, the Thermo Fisher machines another 1.4 million per week.

    The more the merrier. Isn't competition grand?

  • There's a vaccine, but they're saying it will take a year or longer to get regulatory approval. Somehow I feel multiple regulatory agencies around the world could work together to test this and vastly speed up its approval and deployment.

  • Roche cobas® 6800/8800 Systems (Score:3)

    by nbauman ( 624611 ) on Sunday March 15, 2020 @03:01PM (#59832956) Homepage Journal

    Beautiful video of the Roche cobas 6800/8800 Systems.

    https://diagnostics.roche.com/... [roche.com]

    DNA testing kits have 2 parts. (1) First you get a nose or throat sample with a Q-tip and put it in a tube. (2) Then you extract the DNA and see whether it contains the sequence you're looking for.

    The cobas 6800/8800 Systems is the second part.

    The press release is here.

    https://www.roche.com/media/re... [roche.com]

    They've really automated that stuff since I did it in a biology lab.

    They should rate these machines by the number of biology graduate students they can replace, like horsepower. "This machine can do the work of 1,000 graduate students."

Slashdot Top Deals

A morsel of genuine history is a thing so rare as to be always valuable. -- Thomas Jefferson

Close