Disruptive Bloodwork Startup May Offer Mostly Vaporware

dmr001 writes: As seen previously, Palo Alto startup Theranos planned to put the power of affordable lab work directly in the hands of patients with tiny fingerprick samples taken at Walgreen's, with four hour turnaround. The company claimed their tests were "made possible by advances in the field of microfluidics." But they were cagey about methodology and didn't use FDA approved analyzers.

Now, the Wall Street Journal reports (paywalled) (among others) that all but one of Theranos' analyzers currently in use is off the shelf, and that their tiny samples may not always have been accurate. Typically cagey founder Elizabeth Holmes vigorously disputes the criticism of her $9 billion startup, but entrenched players like Quest Diagnostics and LabCorp (which do quite well charging orders of magnitude above Theranos' prices) are likely doing a happy dance.

Physicians worrying about patients bringing in their own carcinoembryonic antigen levels and Epstein Barr Virus panels to confirm their Internet diagnoses of cancer and chronic fatigue may also be breathing sighs of relief, albeit with bittersweet regret at the potential loss of the price advantage and milliliter samples.

Comments

Argle Bargle Morble Whoosh?

[ColdWetDog]

that all but one of Theranos' analyzers currently in use is off the shelf,

What. Wait.... Is it supposed to be on the shelf? Is there something missing?

TFA in Business Insider just complained about the membership of the Board of Directors (which is weird).

And finally, ** 10 billion dollars ** for a startup that does essentially the same thing as everybody else but maybe undercuts price and probably violates the law in 45 states?

I'm in the wrong business.

Re:Argle Bargle Morble Whoosh?

[dmr001]

Theranos' "Edison" analyzer is purported to allow accurate, cheap testing with tiny sample sizes. They haven't revealed a lot about how it works. This is in contrast to standard analyzers which cost more (well, they charge more), need your typical 10 ml Vacutainer sample, and have lengthy turnaround times. It turns out Theranos has recently been using standard, commercially-available analyzers for most of its tests, and had to dilute its samples to do so, apparently compromising accuracy.

As the OP, I'm hopeful Theranos now can pull up out of this apparent nosedive, and publish controlled analyses in larger, controlled trials in a peer-reviewed journal. Then the real miracle will be integrating their results with everyone's frickin' EMR.

Re:Argle Bargle Morble Whoosh?

[ColdWetDog]

Ten billion dollars based on a system that has been purposely obfuscated?
I am definitely in the wrong business.

Most of the commercial analyzers only need a couple of hundred microliters. They get 5 cc or so out of the patient because it's easy, rarely is problematic (except in tiny infants when the only draw a cc or so) and allows for repeats and storage (the Illuminati needs to get its samples from somewhere. And they really only take a few minutes to run. The big time waster is paperwork, spinning the sample to get rid of red and white blood cells and batching the samples to lower cost.

Fingerstick samples (Capillary blood) are somewhat problematic in that the normal values aren't necessarily the same as in serum samples. But that can be controlled for.

Ten billion dollars?

I quit....

Re:Argle Bargle Morble Whoosh?

[Trepidity]

The company really seems, from the outside, to be in one of those self-powering ascents at the moment. They got some money, with which they got influential people on board, with which they got more money, etc. And it definitely helps that they signed on Walgreens as a customer, too, which makes it look like it has a real business, not entirely vaporware.

The board is really absurdly packed with political heavyweights though, to the point where it tips over from looking like "impressive board" to weird and kind of suspicious. I mean one of their directors is Henry Kissinger. Not just someone with the same name, either, the Henry Kissinger, Richard Nixon's Secretary of State who is now 91 years old.

Another disruptive company...

[DRJlaw]

But they were cagey about methodology and didn't use FDA approved analyzers.

Further proof that, far more often than not, "disruptive" means ignoring the law for as long as humanly possible while hoping that your competitors can't (or won't) follow suit.

I can't wait for "disruptive" medicine as practiced by anyone with internet access and a hyperlink to WebMD.

Anything to disrupt Quest Diagnostics

[tompaulco]

Anything to disrupt Quest Diagnostics. I wouldn't use this new outfit because they sound sort of shady, but I won't do business with Quest either. Their prices are insanely high, and they always automatically bill the patient first instead of billing the insurance because they know the insurance will adjust it down to a contracted reasonable price. I have had to spend thousands of dollars of my time on the phone with this company just to get them to bill the insurance company. They have threatened me with debt collection over a debt which I would have happily paid if only they would submit it to the insurance company so I knew how much I actually owed. I certainly didn't owe them the full amount they stated. I have repeatedly told doctors not not to send my bloodwork to Quest, but I guess they are a monopoly or the doctors get kickbacks because they always send the bloodwork to them, without first getting signoff from you about which tests will be performed or getting agreement to pay from you.

Re:Anything to disrupt Quest Diagnostics

[whoever57]

Let's be realistic here: medical insurance in the USA is a rip-off. Unfortunately, it's also necessary.

I suspect that those co-pays are in many cases all the the provider actually gets. In other words, my company and I pay something north of $20k/year for what is mostly a glorified discount program.

What happens is that the provider bills some amount (say $100 for example), the patient pays a 10% copay and then the total bill is discounted by 90%, so the insurance company actually pays zero. There is a bonus for the providers: they get the full cut from patients who have not met their annual deductible.

I wonder if some of the arrangements are legal: when I phone one medical provider for a discount on a $600 bill for an office visit, I was told that they had an agreement with the insurance company so they could not discount. In other words, two companies agree that a third party cannot get discounts: sounds like something that an anti-trust regulator should investigator should look into.

There was another insult following that conversation when I asked for a discount: my entire bill was sent to a debt collector, including some items for which I had not received the bill. Scum. I paid the debt collector instead of the medical practice on the basis that the medical practice that did this would get less money out of the deal

Re:Anything to disrupt Quest Diagnostics

[Octorian]

And yet, whenever the healthcare reform debate comes up in the US, it seems as if *both* sides of the political isle managed to *completely* ignore everything you just said when formulating their respective outrages and talking points. If only this problem was actually dealt with (and the situation would likely be illegal in any other industry), people wouldn't be so financially dependent on health insurance providers in the first place.

Re:Anything to disrupt Quest Diagnostics

[tompaulco]

Also, Quest does not automatically bill the patient first.

Yes, they do. I go to the doctor, they have my insurance information, they send in the bill to the insurance, I get a bill from the provider. The provider sends bloodwork off to a lab of their choosing (despite my objections), the lab has my insurance information, they send me a bill. They don't bill the insurance, I call them, they don't bill the insurance, I call some more, I send letters, they don't bill the insurance. Eventually, they start threatening collections. But how can you collect on an amount when you don't know how much that person owes because you have not yet billed their insurance plan?

Stop blaming your doctor for your own incompetence.

I'm incompetent? I don't work at the doctor's office. How do I control who they send their labwork to. I can and have told them not to send the bloodwork to Quest. They do it anyway. You don't get to decide where it goes, you don't get to just "send" it yourself. The doctor's won't give you your bloodwork even though it came out of your body and they technically should have to get your permission to do anything with it.
I guess you like you getting gang raped by the insurance/doctor/lab companies and that is why you act as an apologist for them.

Re:Anything to disrupt Quest Diagnostics

[sociocapitalist]

And yet, whenever the healthcare reform debate comes up in the US, it seems as if *both* sides of the political isle managed to *completely* ignore everything you just said when formulating their respective outrages and talking points. If only this problem was actually dealt with (and the situation would likely be illegal in any other industry), people wouldn't be so financially dependent on health insurance providers in the first place.

I am an American living in France.

When I go see a doctor, I pay 20 euros. However much else there is to be paid is paid directly by the state.

I recently saw a specialist surgeon for my knee. Cost me 60 euros. No idea how much he got paid by the state and I couldn't care less.

That same surgeon did my knee ligament and a bit of meniscus, both damaged during a fall skiing last year. In one day, out the next day, latest medical advances (tiny scar, everything done by camera - I even got a video afterwards). Cost me something like 330 euros. Can't remember exactly how much but when I said "Oh my god" it was out of shock that the bill was so small, not that I would have to sell my kidney to be able to pay it.

Do I pay higher taxes?

Yes.

Do I get something for my taxes?

Yes. In fact, not only do I get almost free excellent medical care - my kid will get excellent free university (assuming he passes the competitive exams which I'm quite confident about).

No immense student debt hanging over his head.

No getting fucked by the medical and insurance industries.

I have no problem at all about the taxes I pay now versus what I did living in the US.

I wish I could bottle up this experience and jam it down the throat of every idiot that says 'socialized medicine bad thing big government blah blah blah fucking blah). Instead to them I say - come live over here for a year and experience just how GOOD it is to not get completely fucked over when you go to the doctors.

I note no test for CFS exists.

[queazocotal]

Even the best testing panels have only found markers for CFS in a statistical manner.
That is - you take a hundred people with CFS, a hundred people without CFS, and you can with certainty tell which group is which.
However, you can't with any useful result test a single individual.
The false positive rate is 45%, and the false negative rate is 45% or so.

CFS is not one disease, it is almost certainly many.

Everything about Theranos is lol

[hsmith]

Silicon Valley and the media want so bad for a successful female "founder" that it hasn't gotten off its knees for this woman.

"10 years in stealth mode" is hilarious

Anyone else would have been laughed out of the room with what has come out about Theranos as of late. Claims too good to be true dreamt up by a college kid? Yep, they are probably too good to be true.

Re:CEO Elizabeth Holmes

[lucm]

if you look carefully at many of her pictures, especially close-up shots, she looks like someone who wears a latex mask. Maybe it's Steve Jobs underneath, that would explain the voice and how she dresses.

Re:I'm just gonna lay this out there

[lucm]

I'd rather trust 10B of funding than an article on the WSJ

That's what Enron shareholders used to say.