LabCorp’s at-home Covid-19 test kit is the first to be authorized by the FDA | Hacker News Reader

LabCorp’s at-home Covid-19 test kit is the first to be authorized by the FDA

techcrunch.com

186 pointsjbegley132 comments

$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/

Anyone know if that $119 at cost? LabCorp is going to make a killing of this crisis...

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.

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.

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.

The Labcorp Pixel covid kit is a mail-in sample swap for a PCR test. The variable cost is magnitudes lower than $119.

There is also the variable cost of the technician needed to run the machine, no?

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.

Edit: This isn't a total cost analysis, just labor like the person asked.

I imagine with breaks, lack of 100% focus and efficiency, and employment benefits it's probably $2-$3 in labor costs per test if you're right on the time required and average salary. So, I think possibly multiples of what you quoted, but still so low that it's not likely to affect the cost much.

Then again, with the people to move the samples around (process and sort mail), clean/sterilize testing materials after testing, and manage the people that perform the tests, and do quality testing, you might see another $1-$2 per test in labor costs. So maybe $5 in labor all said?

My bet is that the most expensive part of the process is the machines to do the tests, which likely cost multiples of a lab tech's salary (but maybe can do multiple tests at once? I dunno).

A sibling comment upthread noted that Maryland got 500k tests for $18 each, which sounds like it's probably close to cost, if it's the same test. That number of tests would be about full time work for 400 lab technicians for 5 days if they averaged just under two minutes a test.

Sure, for a routine clinical lab at your local hospital, but Labcorp is one of the largest ancillary lab networks in the world. I would be surprised if they haven't automated or processed out most of the manual labor for sample to diagnostic test.

For the extra labor I was referring to people actually receiving the mail, opening it and getting the samples into whatever tracking they have. My guess is that there's still real people doing that step, since a machine that can do that reliably and not screw up and/or contaminate systems with the weirdness they get in the mail is probably on the order of a machine that can accurate pick items out of bind in Amazon warehouses (or harder), and Amazon has thrown a lot of money at that just to find it's a lot harder than it seems. Even if it's just people receiving the mail and throwing it into a bin that's delivered to a specific lab tech, that still takes people.

The other labor was really just going by your own numbers.

Beyond that, there's still the layers of management above, that while there are physically less of them likely, their pay scales higher as well.

Genuine question: a lab tech in the US handling contegious virus samples for analysis costs only 30 bucks an hour? whats the salary of such a lab tech?

By the time it gets to the lab tech, it's unlikely that the virus would be as viable as it is when exiting the host. This would be especially true if the swab is put into some sort of preservation liquid (I don't know for this test, but often the nasopharyngeal swabs are put in such a fluid). Remember you don't care about the virus, you only care about its genome.

Even if the virus is viable, it's no longer airborne. You'd have to touch the swab and bring it to your face. Most of these labs handle things like HIV, so lab procedures and training guard against this sort of behavior. I wouldn't be surprised if they worked with shields as well.

In short, maybe they should be paid more, but it's not the danger factor that should govern in this particular case.

Typically lab techs are $25-$30/hr, and I doubt they get hazard pay for covid since they're handling contagious disease cultures on the regular. PPE is normally at a high standard for them.

Right, but isn't there capital costs associated with being able to run them?

You realize that the only reason this kit is so expensive is because the FDA previously shut down a bunch of at home testing companies products right?

In case people forgot the first step of the FDA was to shut down at home testing. Then they fast tracked Roche and Thermo Fischer.

Now a month later they approve an expensive at home testing kit. You take your own conclusions of this behaviour.

https://techcrunch.com/2020/03/23/updated-fda-covid-19-testi...

Note that most of the initial tests required a nasopharyngeal swab which has to go back into your nose several inches. I'm not surprised that the FDA doubts that people would be able to do that reliably on their own given that even trained people seem to get it wrong a lot (1).

The LabCorp test uses a swab that doesn't go anywhere near as deep (2). For a test kit to be widely distributed, you need to have it be drop dead simple to run perfectly.

Given all this, I'm not sure we should jump to corruption as the reason this is the first at-home test.

1.) https://slate.com/technology/2020/04/coronavirus-testing-fal...

2.) https://www.fiercebiotech.com/medtech/labcorp-s-at-home-coro...

As another comparison point, Switzerland govt said the insurance companies will pay CHF 180 for a test.

https://www.admin.ch/gov/de/start/dokumentation/medienmittei...

For the curious: CHF 180 ~= $186 USD

The governor of Maryland got 500,000 kits for 18 dollars per kit

From South Korea https://bethesdamagazine.com/bethesda-beat/coronavirus/maryl...

I spent hours on the phone today with labcorp trying to acquire these for our healthcare center staff. Not a single employee knew how to sell them, or that they were even something labcorp offered.

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’.

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.

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.

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...

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/10.1101/2020.04.01.20050005v...

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.

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

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.

https://www.fda.gov/medical-devices/emergency-situations-med...

The FDA doesn't think it is necessary to go that deep.

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.

Even adult noses are different sizes, the depth is a relative measure.

You only need to swab the edge of your nostril for this test.

https://www.pixel.labcorp.com/covid-19-sample-collection

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?

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.

It does move down the respiratory tract, but nasal epithelial tissue can still contain/produce the virus for awhile even after it "moves". For me, I was able to physically feel the inflammation move down from my throat to lungs to abdomen, but that was 5 weeks ago, and I just tested positive on a deep nose swab rtPCR given yesterday. A lot of people are testing positive for surprisingly long time.

I wouldn't be surprised if a light nasal swab like being discussed here doesn't pick up anything post-symptoms, whereas PCR with the deep nasal swab may still be detectable for a longer time after primary symptoms have faded.

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...

> Pixel by LabCorp™ 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.

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.

> 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.

Yeah, I don't know why people heap praise on Cuomo. Dude dragged his feet compared to Newsom and the California local authorities.

Everyone loves a hero. California just kept things under control. No fires to fight = no heroes.

>information asymmetry may lead to loss of profits.

How would this work? You learn of some (useful?) information about your genetics and eat better? And that affects insurance how?

No, they're worried that patients might find out that they have a genetic disposition to disease X, and increase their level of coverage so that when that disease does come along, the insurance company has to shell out for its treatment.

I think there’s another part in that they hope to know more about your health than you do. In fact it seems like the entire private healthcare system is designed to have more information on patients, caregivers, pharmacists and so on than the patients know about themselves. All of this is so they can write policies that make them the most money for the company while shortchanging your health outcomes and your health care providers. Why else would cost of hypothetical future potentially-avoidable preventive care be a worry to a health insurance company? One would think that such predictable expenses are one of the only sure things in the health care system.

They know what most people implicitly know but effectively deny indirectly via ignorant inaction: what you don’t know, can hurt you. The insurance companies also know this.

Looks like New York and Maryland ban consumer initiated lab tests...

https://www.technologyreview.com/2017/09/28/148899/as-consum...

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.

The first paragraph mentions it's just a collection kit. Comes with a shipping label.

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.

Nit: I dampen a towel for use with envelopes and stamps. Who wants to lick that stuff?

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?

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?)

There's one available in Richmond, CA for $125: https://www.sfgate.com/bayarea/article/COVID-19-antibody-tes...

It's $199 (+taxes).

It literally says $125 in the opening paragraph of the article I linked. Do you have updated information?

Yes, the lab itself. https://app.acuityscheduling.com/schedule.php?owner=19381748

That seems very odd considering the SFGate article was published yesterday, and I presume they asked the lab how much it costs. I sent the lab an email to clarify. Let's see what they send back.

While this is walk in, the actual test likely requires an NPI number. There's likely a physician (or mid-level that can prescribe - don't know CA law) that's pretty much there to "check the boxes".

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.

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?

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.

Thanks for taking risks to try and make a difference. I hope you are successful! These tests are pretty simple to administer so there really should be an at-home version.

I'm guessing you've already seen this, but in case you haven't: https://newsroom.questdiagnostics.com/2020-04-28-Quest-Diagn...

Quest is now selling a consumer initiated antibody test. It's not at home, of course.

This is really the direction we need to go. If there was a cheap and quick test, you could monitor your population over time. Relax restrictions with testing prior to restarting activities.

It would go a long way in managing the epidemic while reducing the impact on the economy.

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...

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.

jacobriis pointed out you only have to swab to the edge of your nostril https://news.ycombinator.com/item?id=22935617

Strep tests are just a pain. Had one or two every year of high school.

Any idea what the false positive / false negative rate is?

Yeah, haven't false negatives been a scourge of at-home testing kits released in other countries?

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.

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.

> 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?

In theory, yes. Sensitivity and Specificity should be considered. In practice, there's a lot of BS going on in the healthcare system right now - these tests are often taken at face value.

It's unfortunate, but somewhat understandable given the extreme circumstances of our health care environment. If everyone with mild symptoms (likely not COVID related) had to self-isolate for two weeks, we wouldn't have any healthcare workers left to care for people.

This seems to be a "good enough" approach for most healthcare systems.

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.

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.

> it's not being tracked

Why wouldn't it be tracked?

So if I get one of these tests, and it comes back negative, what does that mean?

That'll you need more testing through the rest of the pandemic until it's either over or you come back positive.

Sounds like a positive test would be a relief then.

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.

> 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.

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...

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).

My concern here is why did you pay over $100 when you felt fine? How often would someone sample themselves without symptoms?

That’s a fair question. I do think some people may buy and take the test if they’ve been in an area where the potential for exposure is high and they worry they are an asymptomatic or presymptomatic carrier.

Even that is no guarantee. Some of the passengers on that cruise ship became symptomatic weeks later.

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.

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?

Given the sensitivity, absolutely nothing. Seriously, a negative only means that the sample swab didn't have COVID on it. This test is not very useful unless you get a positive.

For context, my wife is a physician. Had a patient that turned out to be positive, test negative while in the hospital. A day later, he was intubated. While he was intubated, his original, outpatient, test from 11 days earlier came back positive.

Expecting profit during a catastrophe is exactly why the sitaution is as shit as it is right now.

economic profit, gross profit, operating profit, or net profit?

But then, why would any company take the risk of developing a new test?

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.

In fact quite a number of people are out there working for free because "it's the right thing to do in a crisis."

Are they wealthy? How do they pay rent, food, etc?

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.

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.

Ok, why don't you make a test and sell it at cost?

Corporations are not people.

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.

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).

So what you are saying is that everyone should work for minimum wage, and any wage in excess of that is profit?

I would say anything above your costs of living would be profit in a wage, no?

Existing within a system is not inherent endorsement of that system.

Corporations are not people.

Ok, but please don't post unsubstantive or flamebait comments to HN.

We detached this subthread from https://news.ycombinator.com/item?id=22936488.

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?

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.

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.

How has 21 and Me been dealing with vials of saliva making it to their lab?

Shipping biological hazards is a solved problem.

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?

Follow the money. Who do the CEOs of the cruise ships know that are in Congress?

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.

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.

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