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Medicine United States

Here's Why Rapid COVID Tests Are So Expensive and Hard To Find 75

Posted by msmash from the closer-look dept.
Months-long silences. Mysterious rejections. Here's what's behind the shortages of a critical tool for ending the pandemic. ProPublica: A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious. This was the problem that quick, cheap COVID-19 tests were supposed to help fix. No need to go to a clinic or wait days for results. Just pick up a pack of tests at a local pharmacy whenever you want, swab your nose and learn within 15 minutes if you're likely to pass the virus along. So the ProPublican went to his neighborhood CVS, hoping to buy the required pack of two for $23.99. They were out of stock. Then he went to Rite Aid. They didn't have the tests either. Then Walgreens, then another CVS. All out of stock. The only supplier with a few tests to offer was his sister, who happened to have a few tucked away. It's a familiar experience for many Americans. But not for people in Britain, who get free rapid tests delivered to their homes on demand. Or France, Germany or Belgium, where at-home tests are ubiquitous and as cheap as a decent cappuccino. So why are at-home tests still so pricey and hard to find in the United States?

The answer appears to be a confounding combination of overzealous regulation and anemic government support -- issues that have characterized America's testing response from the beginning of the pandemic. Companies trying to get the Food and Drug Administration's approval for rapid COVID-19 tests describe an arbitrary, opaque process that meanders on, sometimes long after their products have been approved in other countries that prioritize accessibility and affordability over perfect accuracy. After the FDA put out a call for more rapid tests in the summer of 2020, Los Angeles-based biotech company WHPM, Inc. began working on one. They did a peer-reviewed trial following the agency's directions, then submitted the results this past March. In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn't review the rest of the application. Even if WHPM fixed the issues, the application would be "deprioritized," or moved to the back of the line.

"We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal," said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders. An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. "They're neither denying the bad ones or approving the good ones," he said, asking to remain anonymous because his current work requires dealing with the agency. FDA officials said they simply want to ensure that rapid tests detect even low levels of the virus, since false negative test results could cause people to unwittingly spread the disease. They blame the test shortages on an absence of the kind of sustained public funding that European governments have provided. Without it, manufacturers have lacked confidence that going through the FDA's process would be financially worth the trouble.
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Here's Why Rapid COVID Tests Are So Expensive and Hard To Find More

Here's Why Rapid COVID Tests Are So Expensive and Hard To Find

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  • Testing was one of the big failures [pbs.org] early in the pandemic.

    • Re: (Score:1, Flamebait)

      by JackieBrown ( 987087 )

      Apparently it still is but now we need to actually look for a reason other than "Trump is evil".

      • Re: (Score:3)

        by chill ( 34294 )

        That's easy. Now that we've eliminated malice what's left is incompetence. Thank you Mr. Hanlon.

        • Now that we've eliminated malice...

          No you haven't. Chronic "incompetence" is always malicious... cui bono? The unique thing about the American system is that it is entirely based on revenue, no higher purpose in mind

          • Not really true, it's no different from Europe in this regard. There aren't any medical companies that are run as charities, they all have a profit motive to exist. Profit means employees can be paid for their time. Now maybe it it taken further by some companies than others, and some employees are willing to work bit below the local average just to be at a medical company (ie, in silicon valley) while others are not.

            At this point with the testing it's a non-issue really. FDA has approved several quick

      • The difference is that Germany, France, and Belgium are all SOCIALIST, dammit, while the US isn't, and it's every American's right to die because they couldn''t get tested and couldn't afford healthcare! Not like those evil SOCIALIST countries in Europe with free healthcare and cheap/free Covid testing.

  • We also destroyed millions of existing kits... (Score:5, Informative)

    by Faizdog ( 243703 ) on Thursday November 04, 2021 @12:46PM (#61957563)

    BinaxNOW by Abbott is the most common (and only?) at home Covid test approved in the US.

    Stupidly, this summer when they thought COVID was declining, they destroyed millions of kits. Or to be more clear, they weren't assembled yet, but all the components which would have made millions of kits.

    Then they laid off the workers, and shut that whole product line.

    Not too long afterwards, guess what? Oops, Delta variant is spiking.

    Can't get it all up and running fast enough. Nationwide shortage.

    Stupid, short sighted, short term corporate thinking.

    https://www.fiercebiotech.com/... [fiercebiotech.com]

    https://www.nytimes.com/2021/0... [nytimes.com]

    • Then they laid off the workers, and shut that whole product line. ...
      Stupid, short sighted, short term corporate thinking.

      To quote one of my favorite lines from "Better Off Ted":

      "‘Money before people.' That’s the company motto - engraved right there on the lobby floor. It just looks more heroic in Latin."
      -- Veronica Palmer [href.li] (Portia de Rossi), “Racial Sensitivity,” Better Off Ted [href.li]: S1, Ep4

  • Profiteering (Score:2, Insightful)

    by fermion ( 181285 )
    The reason that it is hard to find rapid tests is because people are not getting vaccinated and more firms are requiring tests for unvaccinated. If we were only testing symptomatic kids who may come in contact with susceptible population there would be plenty of tests.

    It is true that the profiteers want to bypass government regulation and get their quack tests on the market. And investors always complain when their incompetence results in a shoddy product. Of course the reason drugs cost so much is that i

    • Re:Profiteering (Score:5, Interesting)

      by bradrum ( 1639141 ) on Thursday November 04, 2021 @12:58PM (#61957603)

      None of this happened or is a problem in the EU. You can test your kids with the sniffles all you want. And tests for coworkers that aren't yet vaccinated or don't want the vaccinated are not a problem either.

      Same with the masks, N95 (ffp2 masks in the EU) are and were everywhere and cheap, despite the high demand. Hell they gave them away even when you had shortages in the US. It is amazing how when a government actually determines that something is in the public interest and makes it...it actually gets made, instead of depending on some company that might not see a long term profit in something.

      The problem always comes down to the government in the US, where other governments have stepped in and went ahead with creating PPE because it was in the public interest.... even if companies didn't see a profit . Whereas in the US, you don't have that and the waves are still hitting the US market. It is stupid really, given how much the US could have accomplished but just didn't want to.

      • Re:Profiteering (Score:5, Informative)

        by MemoryDragon ( 544441 ) on Thursday November 04, 2021 @01:06PM (#61957625)

        I can second that, rapid tests are either free or 5 bucks, you even can get a PCR gargle test in areas where I live and drop it into the next supermarket box to get the PCR result within 18 hours (absolute gold standard for testing)
        KN95 masks are buyable in the supermarket atm for 59 cents a piece here.

      • "*N95" masks where available during the whole pandemic worldwide with free shipping from china via places like aliexpress. Some of these certainly where not actually conforming to ffp2/*N95 standards yes, but they surely where better than surgical masks or a random piece of cloth. I do remember trying to tell this to some people who claimed un-availablity in the US, but i was generally ignored.

        • That is nonsense and Americans should actually face the fact that the government fumbled the ball.

          N95 masks should been at pretty much every pharmacy in the states to even be in the ballpark of what EU had. Hell they even gave away FFP-2 masks away to vulnerable groups across Europe, when the CDC was still advising that they were only for medical professionals.

          Same thing when the test production ramped up. Now the market is absolutely flooded with tests in the EU.

    • Re:Profiteering (Score:5, Insightful)

      by thegarbz ( 1787294 ) on Thursday November 04, 2021 @01:13PM (#61957651)

      and more firms are requiring tests for unvaccinated

      I've not heard of a single place ever accepting a home rapid self test as proof that you don't have COVID, so sorry I don't buy it. We got this shit coming out of our ears in Europe despite an outright testing culture. Heck at once point this year before the COVID access pass became a thing shopping malls were just testing everyone as they came into the parking lot. Back then these things were dirt cheap and easy to come by and now I've literally got boxes laying around as we get given 2 a week for free from the wife's work.

      I don't buy for a moment that demand alone is causing America grief especially considering this is just the latest example of a medical supply / device that is harder and far more expensive to get in the USA than in Europe.

      It is like the PPE shortage at the beginning of this thing, and a contract with a fly by night company for millions.

      That is actually a good analogy since the PPE shortage you had was again entirely of your own making as you were completely unprepared and sidelined your own manufacturers early on as the virus outbreak happened. Your government is an absolute mess when it comes to the medical industry, it's nothing more than that.

    • Re: (Score:3)

      by pesho ( 843750 )

      Greed is a large part of the problem. FDA is not blameless as their approval process for COVID19 tests is indeed meandering in my experience. On the other hand when they eased up on the emergency approvals they unleashed a flood of "rapid" tests that were pure garbage. I can't blame them for tightening the requirements for approval. These requirements are very reasonable. There is no reason why we would need so many "rapid" tests. Vaccines are widely available and free to any one. Face masks are cheap and b

      • If you are sick you avoid contact, regardless if you have COVID, Flu, RSV, or plague.

        If only it were that easy. Far too many bosses are too stupid and shortsighted to figure out "forcing sick employees to come in and make everyone else sick" is the wrong move. Unless paid sick leave is mandated, we will continue to see superspreader events at workplaces. Because thanks to now four decades and counting of the working American people being screwed, most people can't afford to take unpaid sick days. Assumi

      • Re: (Score:1)

        by carton ( 105671 )

        Vaccines are widely available and free to any one.

        Vaccines don't substitute for tests because they're not as effective as a test at preventing spread to a vulnerable person. That's why tests and vaccines are often used by the same people.

        According to Israeli studies, and confirmed by several others, all cited by the CDC's July 29th leaks, [washingtonpost.com] RRR on becoming infectious is <50% and the viral load is similar in vaccinated vs unvaccinated. The risk to the vaccinated person is much lower, but vaccines aren't a substitute for testing for stopping spread in hig

      • They don't give you a "yes" or "no" answer. To get to the "yes" or "no" answer the manufacturer sets a signal threshold: anything below the threshold is considered negative and anything above the threshold is considered positive. This means that the rapid tests are prone to false positives and false negatives.
        That is completely wrong.

        Quick tests are working like a litmus test. They can have false positives and false negatives, but that has nothing to do with any threshold. They are false negative if you po

  • I just checked in my area of NJ, no problem getting a rapid test tomorrow

    • I just picked a couple packs yesterday, no problem. I'm guessing it's probably a local shortage.

      • Re: (Score:2)

        by carton ( 105671 )

        I just picked a couple packs yesterday, no problem. I'm guessing it's probably a local shortage.

        agreed. unfortunate we're reduced to dealing with anecdotes.

    • Very much so.

      In my area (central coast of california) there are stacks of the home test kits available at the local CVS and Rite Aid pharmacies. We also have an abundance of urgent care clinics (5 over the 3 miles between my home and business!) with large signs in the window offering free, walk-in, no-appointment-necessary, while-you wait, testing for covid.

      That doesn't mean it is easy for everyone, everywhere. It likely is not. But it is rarely as bad as the news makes it out to be.

  • Spoiler Alert: (Score:3, Informative)

    by thegarbz ( 1787294 ) on Thursday November 04, 2021 @01:06PM (#61957627)

    American Medical System. If one of you people with your 3rd world "best in the world" health system need a COVID rapid test just send me a message, I have 14 of them lying here on account of us constantly getting given them for free (wife's a teacher so she gets 2 a week), that and they only cost $10 for a 5 pack at the local pharmacy anyway.

  • Really? (Score:5, Informative)

    by jabuzz ( 182671 ) on Thursday November 04, 2021 @01:06PM (#61957629) Homepage

    Must have a crap government then. I just picked 14 lateral flow tests up at my local chemists for free yesterday no problem in the UK.

  • The FDA has never been fast (Score:4, Informative)

    by mveloso ( 325617 ) on Thursday November 04, 2021 @01:09PM (#61957639)

    The FDA has never been a speedy organization.

    Remember, Trump forced the FDA to stay past Friday at 5PM to approve the first vaccine because they were going wait and do it on Monday.

  • The FDA is the wrong department to be handling diagnostic tests like this in the first place. There is nothing injected into the body, there is nothing ingested through the digestive system. Therefore this is neither a 'food' nor a 'drug'.

    So the FDA should just stay the hell out and turn such regulations over to another department that is better equipped (that is, less damn paranoid) to handle such matters.

    • Re: (Score:2)

      by acroyear ( 5882 )

      yeah different if this was a test that involved something like taking a dye for an MRI system to follow your blood stream - there's something ingested there.

  • If in the future we want to reduce bureaucracy, this is a great example of why it's so important. If bureaucracy prevents rapid COVID tests from being approved and sold, then people can't get a COVID rapid test, and so they will probably just risk infecting others, and those infections lead to increased deaths. Bureaucracy can literally kill people.

    • Re: (Score:2)

      by Tablizer ( 95088 )

      As I explained in another message, much of the heavy testing is to make sure conservative pundits can't find weaknesses to bash the whole process with. The anti-regulation groups brought this on themselves.

  • .. you should vaccinate the beagle first. Can a beagle get vaccinated? How about Gambian giant rats that can be trained to sniff out land mines?
  • This will be a non issue soon if the numbers continue to play out

    • You people have been telling that since summer 2020.

      • I did not. Who is this we you speak of?

        We have reached herd immunity. Please look at the data on percentage of people with natural or vaccine immunity, it is approaching 85-90%
        • You can't assume everyone ever infected has natural immunity, it's very unreliable, antibodies don't form at all in a fifth of cases, and it usually wanes even faster than the vaccines. No, your single Israeli study that never made it out of preprint status doesn't override the numerous studies showing it's worse. Further, the vaccines themselves wane, particularly for mild and moderate infections. We're not at the herd immunity threshold, and likely won't ever be without stronger mandates and universal boo
          • Your viewpoint is just not science. Herd immunity and natural immunity are both playing out nicely. Tell you what: take a month off from the news and check the covid numbers then, and get back to me. Plus a month off from the news might make you happier!
  • You know how security experts call various ineffective security measures which nonetheless look like they're doing a lot "security theater".

    If you allow on the market a bunch of rapid tests that have a high false negative rate,
    you're doing "Testing Theater" rather than testing.
    It's solely for the "false" assurance feel-good effect.
    Oh, and the profit.
    • Even if the false negative rate was 50 percent, half of the real positives would be caught, which would have a large effect on exponential growth. But it's much better than that -- https://www.ons.gov.uk/peoplep... [ons.gov.uk]
      • You just can't use a high false-negative test as a screening test e.g. to filter people who are getting on an airplane or entering a different country.

        Without accurate testing, everyone still has to be assumed to be potentially infected, and shouldn't be allowed in to screening-worthy settings.

  • The "overregulation" is caused largely by fear that pundits will trash the whole process if the tests are not accurate enough. Look how hard the anti-vax pundits work looking for "holes" in the vaccine. Thus, it's largely conservatives that are causing the "overregulation" despite claiming to be anti-regulation.

    • Overregulation isn't the issue being described. What you're looking at is simply incompetence. The FDA asking for material it already had, dragging its feet, not following up or sharing it's reasoning, and in the end saying that the problem is that taxpayers aren't subsidizing the industry enough to offset the cost of dealing with... the FDA.

      And no, this isn't because they are afraid of the products facing political criticism. Anything COVID related is a new issue. The FDA has been a convoluted mess o

  • In July I was able to buy packs of 20 tests for 14,95€ each and I had the choice between at least 4 different brands.
    Today the same online store has only one type in stock and it costs 1,75€ for a single test.

  • Up to the free market trying to do it as cheaply as possible. When we threw a s*** ton of money at Pfizer and moderna there was no problems getting those vaccines through. Instead of just throwing money at it though we could have just done it ourselves and saved a lot of time money and effort. But despite what we've seen the post office do for centuries in terms of efficiency nobody believes the government can do anything right because the wait times at the DMV are kind of long sometimes. Never mind the rea
    • Did you forget to read the story? The FDA is refusing to adapt to the situation. "Even if WHPM fixed the issues, the application would be "deprioritized," or moved to the back of the line." In other words, "screw the public demand, we have a flowchart we are not willing to alter just because there's a crisis". And their response? "Taxpayers need to subsidize the companies to make it worth dealing with us."

      Furthermore, your comments regarding the DMV are utter nonsense. The DMV was a nightmare before

  • I knew that I needed a Covid test within 72 hours of entering Hungary, which as an EU nation is in the Schengen zone. The test type requirement was vague, but I assumed they needed a PCR test because that is the most expensive kind. The fastest test I could arrange in my rural area was through the Walgreens drug chain. I set one up for the day before my flight, took it, and then drove to the big city for my flight. Results were promised in 24 to 48 hours.

    At the airport, I discovered that Hungary's requireme

    • I discovered that Hungary's requirements were not good enough for United AIrlienes. They needed results to be available before my flight left.
      That is basically true for every airline. They usually check if you fulfill all the requirements to enter the destination country.
      I had really trouble with air France once because my return flight was not in the proposed 4 weeks window, but 8 weeks (as I planned to extend my stay at the destination). Point: my flight was not with Air France, they only did the "ticket

  • The problem with rapid tests is that let's say the chances of having COVID are 1 in 500 but the test has a false negative/positive or 1 in 100. They're going to report more false results than they do true results.

    They probably serve as a useful screening tool when someone has the symptoms of COVID (thereby lowering that 1 in 500 to maybe 1 in 30, equivalent to the 3% of PCRs that come back positive), they're no damned good in the general purpose use. If you screened 100 people getting on a plane, or 5000

  • I went to a clinic in NYC last week because I was exposed to a breakthrough case at work. At 4 pm, I was swabbed. At 5:30pm, I got an email with my negative RT-PCR test result. You can have in-clinic tests that are both rapid and accurate.

  • Here's why (Score:3)

    by Malays2 bowman ( 6656916 ) on Friday November 05, 2021 @12:59AM (#61959203)

    Because we are into profiteering and telling people what to do, all while bleating about freedom.

    Seriously, I'm from the US, and my country is a gigantic shitshow. Life has no value here despite more bleating to the contrary.

  • Tkae a gander at this: https://www.cdc.gov/csels/dls/... [cdc.gov] But then do you really need a test that can tell the difference between plain ole influenza and Covid-19? Funny, haven't read much at all about this.
  • Release the damn products. The goal is to reduce transmission of the virus by making more tests available. I rather a person get a false positive/negative then just guess as to their current status. This virus is more like a cluster bomb which generally infects many people at once quickly.
  • If everyone who doesn't actively need a test has "just a few tucked away," that would easily explain why the tests are on shelves. For 330 million Americans to have just a few tucked away, companies would need to have produced and distributed over 1 billion tests. The problem isn't just production, but people stockpiling an item that is in scarce supply.

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