[HN Gopher] LabCorp's at-home Covid-19 test kit is the first to ... ___________________________________________________________________ LabCorp's at-home Covid-19 test kit is the first to be authorized by the FDA Author : jbegley Score : 132 points Date : 2020-04-21 13:37 UTC (9 hours ago) (HTM) web link (techcrunch.com) (TXT) w3m dump (techcrunch.com) | dznodes wrote: | I thought Theranos had those 5 years ago. | btian wrote: | Theranos is a fraud | [deleted] | LinuxBender wrote: | Does "At Home" mean at home, or send the kit from your home to | their lab? It looks like I have to ship my DNA to them. That is | not "at home". | | LabCorp has been hacked enough times for me to stay far away from | them. I was also not impressed with their Lab setup. I had to | help other customers input their sensitive data into LabCorp's | Kiosk systems because their 2 employees were overloaded. I am | happy I left before giving them my data. | | No thanks. | vl wrote: | You send your DNA to someone every time you post an envelope. | LabCorp is the largest provider doing tests, when you are | tested at hospital for example, most likely they will send your | sample to them, so there is no difference with doing it at | home. | SparkyMcUnicorn wrote: | The first paragraph mentions it's just a collection kit. Comes | with a shipping label. | drcode wrote: | Yeah, I'm hoping we'll see serology tests soon that truly are | 100% "at home", operating through a test strip. They already | have had these tests available in China and other countries | since February, but since the US is apparently a third world | country in 2020 we will be lucky to see these tests before | 2021. | chki wrote: | Actually those test strips tests are basically useless at the | moment because they have way too many false positives. But I | think there is some interesting work, so maybe we will see | these tests at some point in an accurate form which would be | extremely helpful. | [deleted] | techdevangelist wrote: | What is the expectation people will actually get the swab far | enough back to collect a meaningful sample? Having been on the | receiving end of a nasal collected flu test, it was a pretty deep | probing. I'm kind of doubtful most people can do it to themself | properly without some prompting to 'go deeper'. | James_Henry wrote: | There's evidence that for Covid-19 it's not necessary to go as | far back as people have been going. There's also evidence that | self-collection works well. The FDA has acknowledged this | before and allowed self-collection with physician oversight | before they allowed this test. | MikeAmelung wrote: | Where is this evidence? How does this square with the | evidence that RT-PCR tests are already coming back falsely | negative, probably due to missing the virus while swabbing? | Pardon me for being skeptical, but this is all from the same | people who have bungled this every step of the way. | cbhl wrote: | I'm having trouble finding the actual study, but | UnitedHealth Group, working with the Bill & Melinda Gates | Foundation, Quest Diagnostics, and the University of | Washington did a study on the efficacy of self-swabbing. | | https://techcrunch.com/2020/03/25/study-behind-updated- | fda-g... | James_Henry wrote: | I found the paper. I haven't read through it so I can't say | if it is actually any good, but it is good enough that the | FDA changed their recommendations because of it (that might | not mean much, of course). | | https://www.medrxiv.org/content/10.1101/2020.04.01.20050005 | v... | MikeAmelung wrote: | Thanks for tracking it down. Doesn't seem to be any | problem with accepting their results that it's almost as | good as a nasopharyngeal swab, so you won't see me | complaining about it again. | takeda wrote: | Not really an evidence, but looks like their instructions | explicitly say to not insert it deep: | https://www.pixel.labcorp.com/covid-19-sample-collection | biased_coin wrote: | Prompting to 'go deeper' could potentially be done over a video | call. I hope LabCorp does some sort of beta testing to know how | well people do with instructions. | James_Henry wrote: | https://www.fda.gov/medical-devices/emergency-situations- | med... | | The FDA doesn't think it is necessary to go that deep. | throwaway55554 wrote: | Put a mark on the swab, put a rubber band around the mark on | the swab and say it has to go back that far. Have a test for | adults and another for children. | | But, the video from the actual labcorp website someone else | posted shows it does not actually have to go very deep. | edoceo wrote: | Even adult noses are different sizes, the depth is a relative | measure. | jacobriis wrote: | You only need to swab the edge of your nostril for this test. | | https://www.pixel.labcorp.com/covid-19-sample-collection | clumsysmurf wrote: | It was my understanding, that its easy to get false negatives | with this kind of test because the virus moves down the | respiratory track as time goes on. Too early, its not | sensitive enough. Too late, nothing there. It has to be in a | specific window of opportunity. Can somebody jump in and | correct me if I am wrong? | fspeech wrote: | It is now thought that the virus can also infect cells in | the nose. Cough and nasal discharge could also bring virus | from deeper parts of the body to the nasal passage. | LatteLazy wrote: | I think they're just assuming you will pay 119USD (Plus tax and | shipping) for a box because coronavirus. What you do with it | after your transaction clears really isn't their concern... | tomohawk wrote: | Found this: | | https://www.fda.gov/media/136151/download | | > Negative results do not preclude SARS-CoV-2 infection and | should not be used as the sole basis for patient management | decisions. Negative results must be combined with clinical | observations, patient history, and epidemiological information. | | Here's a brief article that explains why observed symptoms are | more important than a test: | | https://asiatimes.com/2020/04/how-accurate-are-coronavirus-t... | FootballMuse wrote: | So if I get one of these tests, and it comes back negative, what | does that mean? | vl wrote: | This test is mostly useless anyway: you need to administer it | at the narrow window when you have covid for it to be | effective. This implies that you have to keep it on hand, ie it | can be too late to order it when you have symptoms since it can | be delivered too late to detect anything. Then you have to wait | for results for many days once you send it - so it's useless | for guiding your action during the time you have symptoms. | | If you administer the test when you don't have symptoms it | useless as well since most likely you will miss the window. | SketchySeaBeast wrote: | That'll you need more testing through the rest of the pandemic | until it's either over or you come back positive. | FootballMuse wrote: | Sounds like a positive test would be a relief then. | gweinberg wrote: | Yes. The best situation to be in is to have been through it | and be immune. | | For those of us who aren't showing symptoms and aren't at | high risk for exposure, there's no point in testing us | unless the test becomes super cheap. | macintux wrote: | > The best situation to be in is to have been through it | and be immune. | | I think the jury's still out on the odds of achieving | even temporary immunity after having caught it. | grandmczeb wrote: | All current evidence says infection confers temporary | immunity to the vast majority of people infected. It's | not clear how long immunity lasts, but it's most likely | on the order of years. And even if you lose immunity, the | reinfection will likely be more mild. | | https://www.wsj.com/articles/does-covid-19-infection- | equal-i... | finaliteration wrote: | I'd say it's a relief if you test positive and then 14 days | pass and you experience no or mild symptoms. But I know for | me, personally, I'd be a nervous wreck during that period | waiting for the symptoms to come (but I also have an | underlying respiratory condition so that's a big part of my | anxiety). | SketchySeaBeast wrote: | My concern here is why did you pay over $100 when you | felt fine? How often would someone sample themselves | without symptoms? | TylerE wrote: | Even that is no guarantee. Some of the passengers on that | cruise ship became symptomatic weeks later. | tunesmith wrote: | Not sure why you would take it if asymptomatic (assuming you | aren't an essential health worker), unless you were told to | either as part of a random sample study, or because a contact | tracing effort told you you were at risk. | | If you take it while symptomatic, I believe the sensitivity is | improved, so if it comes back negative, you can be pretty | assured that you just have a regular cold, right? | MikeAmelung wrote: | As a childhood sufferer of semi-regular strep throat infections, | I have a hard time believing people are going to willingly jam | the swab back to where it needs to go. To me, it seems like this | will just generate false negatives. | needle0 wrote: | So this has you take a sample and ship it to their lab. How is | this going to deal with the risk of biohazard for parcel delivery | personnel? | pwg wrote: | Likely something like how this at home mail in test handles | those exact same risks: | | https://www.cologuardtest.com/ | | The sample is sealed inside a heavy grade plastic container | with a screw top lid. | | The plastic container is sealed inside a heavy weight zip-lock | bag already form fitted to the inside of the shipping box. | | The shipping box itself is quite sturdy. | | I suspect something similar for this new LabCorp test, just | customized for a swab. | stronglikedan wrote: | It's no more risky than anything else an already infected | person may ship, which is why the parcel delivery companies | likely already have sufficient mitigation efforts in place. | refurb wrote: | How has 21 and Me been dealing with vials of saliva making it | to their lab? | | Shipping biological hazards is a solved problem. | mdszy wrote: | Expecting profit during a catastrophe is exactly why the | sitaution is as shit as it is right now. | walkon wrote: | Ok, why don't you make a test and sell it at cost? | mdszy wrote: | Corporations are not people. | [deleted] | Wowfunhappy wrote: | But then, why would any company take the risk of developing a | new test? | mdszy wrote: | If you can't see beyond monetary benefit when it comes to | saving lives then I have news for you: you're a psycopath. | sieabahlpark wrote: | How do you stay in business long enough to be able to save | future lives if you don't any money to do so in the first | place. | | Should only billionaires and elite have their drugs? | | What your proposing isn't actually how the world works. Why | don't you go out of your way to go get the same degree as | them and make sure you make the bare minimum. Want to spend | money on that new machine? Can't, you're only able to | charge the cost it took to make the drug, and that new | machine wasn't used so it's not in the price... | | Profits are about growing and expanding the business, | generally a good thing. | mdszy wrote: | You really honestly believe that profits are used by | these companies only for innovation, and billions of | dollars aren't misappropriated to paying overinflated | C-level salaries? | | Good one. | whatshisface wrote: | I think a reasonable calibration would be charity=good, | usual behavior=usual, and active malice=bad. Having a | return around the cost of capital is usual behavior, so I | think complaining about a company profiting off a disaster | by selling the product that they usually make is kind of | like complaining about a person not giving to a food bank. | pmiller2 wrote: | "Usual behavior" should not be "usual" in such an | extraordinary situation as a deadly pandemic. Your | premise is flawed. | whatshisface wrote: | Because of the way our system works, you and I will pay | that 10% in the form of taxes and insurance premiums. I | for one, am glad to reward companies who are contributing | to the solution for this crisis. Profit is the reward we | give to companies for good behavior, and wouldn't you | agree that companies who are making tests are behaving | well? | pmiller2 wrote: | No, I do not agree that profit is the reward for good | behavior, nor that companies attempting to profit off | making the tests are behaving well. In fact, profit is | often the reward for some very, very harmful behavior. I | would say it is at least borderline sociopathic to | conflate the profit motive with the desire to do good. | Your premise is, again, flawed. | | I would be glad to pay for the tests through my taxes if | it means people can get them now, for free. | TheOtherHobbes wrote: | The problem isn't the profit, it's the kinds of | behaviours to which profit is allocated. | | If profit really was a reward for good behaviour, no one | would have a problem with it. (Except bad actors.) | | In this situation, the goal is to get as many high | quality tests out as possible. | | If this is truly a reliable and useful test and results | are available quickly, then the ideal level of profit is | one that maximises that result - i.e. a small profit on | each kit to encourage volume sales. | | If the tests aren't reliable enough to be clinically | useful and they're being sold to the public without a | context (i.e. no information about what the result means | in terms of changed behaviour or risk) then the kits | should be banned for wasting everyone's time and money. | pmiller2 wrote: | If you want to split hairs, I don't have a problem with | LabCorp profiting _per se_ from the test. I have a | problem with the cost being a barrier to people getting | it. If the government were to pay them cost + a small | profit to offer it free at the point of delivery, I would | have no issue. | | I have a philosophical problem with profit being the only | motivation for producing the test, but that takes a | backseat to practicality here. | mdszy wrote: | The current world situation is anything but usual. | bigyikes wrote: | Well that's just it, isn't it? We are talking about | corporations, not people. A corporation is motivated by | profit and is, in some loose sense, a "psychopath." Sure, | corporations are composed of people, but your moral | argument is a lot more complicated in relation to an | aggregate of people instead of just an individual. | | Anyway, more tests are available than would be had LabCorp | not existed, so seems like a win-win to me. | formercoder wrote: | Such a tough conversation. I want to think that these firms | should do this research out of the goodness of their | hearts, but i know that their employees want to go on | vacation and send their kids to college. I believe in the | invisible hand, and honestly don't know the solution to | these healthcare problems. Maybe just raising taxes and | paying for all research by the government, but then I worry | about the inefficiencies therein. | sethhochberg wrote: | Personally I'd love to see someone explore the idea of | incentives that heavily favor benefit corporations and/or | employee-owned coops for commercial activity in direct | support of human rights (assuming we're approaching the | problem from a place where people agree access to | healthcare, medicines, etc is a human right). | | People who do the incredibly valuable work of developing | drugs shouldn't be forced to live a life of squalor, and | can be compensated generously for the value and | complexity of their work, but I think most people's | objections to pharma companies as they typically exist | today are centered around companies reporting substantial | profits and conflated ideas about obligations to | shareholders. | | Its a lot easier to feel good about a company reporting a | profit if you're confident the company's governance | structure ensures that profit is mostly lockboxed for | future R&D instead of a shareholder dividend to people | who may not even know their investment is funding | medicine. | formercoder wrote: | Good ideas, but without distribution of profits how are | these companies going to be capitalized? Maybe government | owns the equity? | nicoburns wrote: | On the other hand, businesses in other industries that are | not so beneficial to society will happily charge gob loads | of money for their services. IMO giving these companies | some profit is a good thing, so long as the money is made | available so that everyone can afford the product, and so | long as it doesn't stop or slow it's distribution. | refurb wrote: | Exactly. I'd love to ask all the people criticizing this to | work for free for a few months because "it's the right thing | to do in a crisis". | | I'm guessing there would be zero takers. | wwweston wrote: | Personally, I _would_ do (and have done) certain kinds of | work without monetary compensation because I want to see it | done, or because I think there 's some other upside. | | However, I probably wouldn't ask that of LabCorp in this | circumstance, because what I want from institutions | providing testing is scaling up while providing an | effective product/service. Not getting revenue makes that | considerably harder. | | Public subsidies might make a lot of sense, though, | especially to the extent that everyone wins the | broader/deeper test coverage is, but not everyone has a | disposable $100. | 1-more wrote: | There's a structural limit to a market based economy that | can only be overcome with central planning. This is it. We | ran into it. | TheOtherHobbes wrote: | In fact quite a number of people are out there working for | free because "it's the right thing to do in a crisis." | Teever wrote: | How have you been foregoing profit for your work during this | calamitous time? Have you been laid off like many people or are | you simply returning the cheques that your employer sends you? | | Personally I've been continuing to show up for work despite my | employer not having sufficient funds to pay me but I understand | that every situation is different. | mdszy wrote: | Existing within a system is not inherent endorsement of that | system. | mdszy wrote: | Corporations are not people. | claudeganon wrote: | Profit != wages. A company profiting off a test is not the | same as a worker being paid for their labor. Something being | made at cost would price in the cost of labor, while profit | is in excess of that (and all other expenses). | ars wrote: | So what you are saying is that everyone should work for | minimum wage, and any wage in excess of that is profit? | revnode wrote: | I would say anything above your costs of living would be | profit in a wage, no? | dang wrote: | Ok, but please don't post unsubstantive or flamebait comments | to HN. | | We detached this subthread from | https://news.ycombinator.com/item?id=22936488. | TomatoTomato wrote: | economic profit, gross profit, operating profit, or net profit? | ianhawes wrote: | > Pixel by LabCorp(tm) is not available in NY, NJ, MD, or RI due | to restrictions on how laboratory tests may be ordered. Please | talk with your healthcare provider about options for getting | tested. | | Ah wonderful, so this rules out states accounting for 45% of the | confirmed cases. | hnburnsy wrote: | Looks like New York and Maryland ban consumer initiated lab | tests... | | https://www.technologyreview.com/2017/09/28/148899/as-consum... | joncrane wrote: | I remember when they banned 23andme in MD, I researched it and | it turns out the health insurance companies successfully | lobbied against it with the argument that information asymmetry | may lead to loss of profits. | | I'm still salty and I think this is part of the same scenario. | | Having said that, I think Governor Hogan is one of the best | governors out there wrt state level response to Covid. Right up | there with Newsom and Cuomo. | chimeracoder wrote: | > Right up there with Newsom and Cuomo. | | Cuomo cut Medicaid funding by $6 billion _during_ the | pandemic. He dragged his feet on issuing a stay-at-home order | for a week after the city government had asked for one (the | governor has the sole authority to authorize one in NY). San | Francisco beat Cuomo to the punch by nearly a week, even | though New York had been hit earlier and harder with COVID-19 | cases. Cuomo also fought against closing NYC schools even | after the city and teachers were already on board with the | idea. As a result of New York 's sluggish response, community | spread of COVID-19 happened much more rapidly than it did in | other urbanized areas of the country (most notably San | Francisco), so hospitals were already overloaded even before | the stay-at-home order had been issued. On top of that, Cuomo | also expanded pretrial detention for nonviolent drug | offenders during the pandemic, which puts even more people in | unnecessary close contact. | https://nymag.com/intelligencer/2020/04/cuomo-has-learned- | no... | | As of today, 1 in 1000 New Yorkers who were alive a month ago | are now dead. Cuomo might not be the only person responsible | for the current situation in New York, but it's clear that | things would be better in New York had Cuomo taken action | instead of fighting public health officials at every turn. | tomohawk wrote: | Any idea what the false positive / false negative rate is? | gshdg wrote: | Yeah, haven't false negatives been a scourge of at-home testing | kits released in other countries? | WoodenChair wrote: | Is there a possibility of us getting an FDA sanctioned OTC | antibody test in the near future so we can find out if we already | had the virus? | James_Henry wrote: | I'm sure it will come, but it looks like the FDA is waiting | until the big companies ask for an EUA because they don't trust | the startups (or the startups aren't able to do what LabCorp | does?) | zenyc wrote: | We are working on this. I can't share more here but if you are | interested and want to help, let me know how at | zen[at]rapidcov[dot]com (dev, design, marketing, medical, | partnerships, etc). We have our core team in place but we are | planning to be bring on more people in the next few weeks. | | P.S. ignore the website, it's not the product. | James_Henry wrote: | What would make you different from the many many EUA antibody | tests already on the market? How are you going to get yours | approved for OTC at-home use? | zenyc wrote: | Originally, we tried to bring the existing antibody tests | that can only be sold to medical practitioners. During that | process, we engaged in conversations with the FDA to get | approval and we asked them what their concerns are with at- | home antibody test kits. Once they explained us, we went | back to the drawing board and worked on a solution that | would allow us to mitigate the FDA's concerns. | | We then proceeded to present our solution to the FDA. They | were positive so we filed for our pre-EUA and now we are | working with an FDA reviewer. | | I'm not going to pretend that our solution will end being | approved. I have no idea since none of us (the three | founders) have medical device experience. Nonetheless, we | are willing to take a huge risk in terms of money and time, | and at least know at the end that we gave it our best shot. | pmiller2 wrote: | There's one available in Richmond, CA for $125: | https://www.sfgate.com/bayarea/article/COVID-19-antibody-tes... | renewiltord wrote: | It's $199 (+taxes). | pmiller2 wrote: | It literally says $125 in the opening paragraph of the | article I linked. Do you have updated information? | renewiltord wrote: | Yes, the lab itself. https://app.acuityscheduling.com/sch | edule.php?owner=19381748 | LatteLazy wrote: | Before people get excited that the FDA approved something, how | much testing have the FDA done on this product and how many other | tests have they declined to authorize? | | Right now, FDA approved means about as much as Probably not | immediately lethal. | stronglikedan wrote: | $119 [0], since it's not mentioned in the article. | | Also, not yet available to the masses: | | > With limited quantities of kits available, Pixel by LabCorp is | currently prioritizing healthcare workers and first responders, | consistent with guidance from the CDC. We plan to make kits more | broadly available soon so please check back. | | [0]https://www.pixel.labcorp.com/ | fmakunbound wrote: | Anyone know if that $119 at cost? LabCorp is going to make a | killing of this crisis... | malandrew wrote: | Maybe, maybe not. Their other tests have almost no demand | right now due to coronavirus. How much of a killing they make | will depend on which tests have better margins. | hbosch wrote: | I believe LabCorp's Men's Health Test is relatively popular | amongst guys looking to check their testosterone levels. | The results can be taken to a "men's health physician", or | a "bio-identical hormone physician", or whatever else they | are called and used to justify legal hormone therapies | (typically testosterone injections and/or estrogen- | blockers). Common for bodybuilders, or even just dudes | closing in on 60 who want to stay good at golf. | stronglikedan wrote: | Likely not "at cost", since a for-profit company should be | expected to be making a profit, but probably close, | considering the herculean effort to get these things to | market, despite the red tape. | three_seagrass wrote: | The Labcorp Pixel covid kit is a mail-in sample swap for a | PCR test. The variable cost is magnitudes lower than $119. | James_Henry wrote: | There is also the variable cost of the technician needed | to run the machine, no? | three_seagrass wrote: | Lab techs will spend at _maximum_ a couple minutes on | each test, if they are manually preparing and pipetting | samples, as the majority of the test is automated on a | PCR thermocycler. At $30 /hr that's $1/test in labor at | most. | foota wrote: | Right, but isn't there capital costs associated with | being able to run them? | nikofeyn wrote: | how does this help? if you can test at home, so what? how does | that change anything? it's not being tracked, can you trust | results, etc. | gweinberg wrote: | Saves the risk of infecting someone or being infected at a | testing center. You don't want to be going near a hospital | these days if you don't have to. | KaiserPro wrote: | Isn't it a notifiable disease? Wouldn't that put the onus on | the testing company to report a positive test? | | I'm not sure how that works in the states. | SkyPuncher wrote: | It won't do much for most people - which is why healthcare | workers and first responders are being prioritized. | | My wife is a doctor and cared for our county's first COVID- | positive patient before he was formally diagnosed (took 11 days | to get test results). She was on self-isolation for 3 weeks for | late March/early April. Two weeks for the initial exposure, 1 | more week because of a low-grade fever. We're still not certain | if she had it (I got symptoms about 5 days after she did) | because it was extremely difficult to get her tested. | | The challenge now is monitoring her with likely exposure when | she'll be working in-patient for the month of June. While these | tests aren't perfect, they can give us some direction on how we | need handle things at home. The price is reasonable enough that | we can simply order the test for her directly without having to | call 20 different people across 3 different hospital systems to | get the sign-off on testing. | | A negative doesn't tell us much (as she could still have it), | but a positive is a strong indication that she should be | avoiding patient interactions and likely self-isolating at | home. | SketchySeaBeast wrote: | > A negative doesn't tell us much (as she could still have | it), but a positive is a strong indication that she should be | avoiding patient interactions and likely self-isolating at | home. | | Doesn't it only tell you if you should now be immune once | your sickness is over? Otherwise you have to act like you | have it if you have the symptoms regardless of the test. | Avoiding patient interactions and self isolating should | happen regardless, shouldn't it? | ck2 wrote: | Well, it's three months and 40,000 deaths late but it's a start. | | But there needs to be anonymous antibody testing at home like a | pregnancy test. | | BTW also needs the post office properly funded and saved from | bankruptcy. WTF are we bailing out cruise ships and not the post | office? | renewiltord wrote: | Well considering it's been three months and 40k deaths and you | have given us nothing, I'm going to go with the guy who gave me | something. | throwaway55554 wrote: | Follow the money. Who do the CEOs of the cruise ships know that | are in Congress? ___________________________________________________________________ (page generated 2020-04-21 23:00 UTC)