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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.
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.
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.
Faster! Faster! Faster would be better!
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. 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.
If you are not allowed to question your government then the government has answered your question.
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.
I got a test from Labcorp via one of those shady online doctors. They price was cheaper than my copay if I used my insurance. Apparently the negotiated cash discount is huge.
I love Jesus, except for his foreign policy.
But I'd rather trust 10B of funding than an article on the WSJ that could very well be a public opinion bomb from the highly influent big pharma lobby. My two cents
CEO Elizabeth Holmes is fucking gorgeous!
Unfortunately, she sounds like a man.
Hottest. Vader. Impression. Ever.
Pretending this is my office full of bitter coworkers..
The minute you have a backup plan, you've admitted you're not going to succeed." -Elizabeth Holmes
Now, if you'll excuse me, I have backups to corrupt.
How on earth did it become *so* expensive? This is not a problem in other countries, where pathology is an order of magnitude cheaper than the US. And it is paid for by governments which makes it free to patients in other western countries (certainly here in oz). And no, that does not kill the national budget -- detecting issues early with pathology often saves the government money.
I'm not seeing anything suggesting that their service is unreasonably error prone, just a bunch of complaints about how the ratio of medical professionals on their board "doesn't fit" with that of other multinational medical corporations. And even if their testing is not perfect widespread and cheap blood testing could still be of significant use. Even if you come back positive with some serious illness via an expensive test you should be retested to ensure that there wasn't a mix-up, same thing goes with cheap tests. False negative results are a bit more tricky but one should probably be cautious in regards to that possibility no matter what.
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.
Are you sure she exists? She looks like a digital animation to me.
The real "Libtards" are the Libertarians!
idk i think you're overreacting and overexxagerating.
Hottest. Vader. Impression. Ever.
I dunno... having her shout out "I am your father!" at the wrong moment would probably leave me needing years of therapy afterward.
#DeleteChrome
You say insurance is a rip-off. Amen to that.
But you also say that is "necessary"... You mention following epithets: Debt collection scum, considering anti-trust regulators, calling them a glorified discount program.
Yet all of this "necessary"?
Insurance is a relatively new invention, and like, many new inventions, are not necessarily designed to defend consumers.
In medieval ages Arab medicine was considered one of the best in the world. Chinese medicine was also highly advanced. All of the medicine prior to the XX century, whether advanced or not, had one thing in common and it was pay-as-you-go-basis.
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If barbers and hairstylists were smarter, they would start their own hair cut procedure medical plan. After all, you will not start cutting hair yourself. You also need a training too.
DYI medical diagnosis is the future and it is something we need.
Before someone says "home users should never use such things because only doctors are qualified"... what about home pregnancy and blood sugar and blood pressure tests and blood alcohol tests? So saying that only doctors can give tests is asinine.
Here is what I see people doing... they take the tests to know whether they should see a doctor or not.
*drops mic and walks*
I've decided to stop wasting my time responding to AC trolls/sockpuppets... so if you want a response from me... login.
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.
lucm, indeed.
A simple explanation of how Theranos managed to line-up Walgreens is that Theranos may have offered a large discount over standard lab pricing. But if, in fact, Theranos is running most of their tests on standard (or even slightly-tweaked standard) lab analyzers, how long can Theranos afford to operate at a large discount?
Unless they really have a big technological advantage over standard labs, which I doubt, then eventually Theranos is just another standard clinical lab operator, presumably operating at standard prices, and presumably valued at standard clinical lab valuations (much lower).
There's something about a person leading a health care company dressing like the grim reaper that just doesn't work.
Personal attacks on company's 'cagey' CEO and corporation in the first two paragraphs.
This couldn't possibly be a biased post at all.
So sick of spin and hype...
~ People that think they are better than anyone else for any reason are the cause of all the strife in the world.
Yep. Mod up!
~ People that think they are better than anyone else for any reason are the cause of all the strife in the world.
He tried Theranos blood analysis and is not impressed.
http://www.mondaynote.com/2015...
An alternative link that actually works without Flash (at least so far):
http://finance.yahoo.com/video...
That entire response was about their little plastic tube that stores the collected blood and the fact that they are working with the FDA on approving the little plastic tube. What does that have to do with actually analyzing the blood? I realize the collection method is part of it but that should be the easiest part of this process.
he spends the whole summary being FURIOUS that Quest Diagnostics and your doctor aren't being "disrupted," rather than the fact that ... this "stealth startup" seems to have pulled a billion-dollar scam on investors?
She lost me when she mangled the Ghandi quote: "First they ignore you, then they laugh at you, then they fight you, then you win."
Protip to tech CEOs: Don't compare yourself to Ghandi. You sound like an ass.
In other words, you are a quack that believes in homeopathy? I'll thank the FDA for keeping you away from treating people in the US.
APK likes to ask for responses to the same things over and over. Maybe he just likes the responses?
Yeah, pretty amazing. No lab has any of their tests validated by the FDA, how dare Theranos get their first one validated. They should be shot for trying to enter the medical market, it is what their kind deserves right? /s
Dumb AC is Dumb.
APK likes to ask for responses to the same things over and over. Maybe he just likes the responses?
https://www.theranos.com/our-l...
We are voluntarily submitting all our tests to FDA even though we don’t need to – opening up to regulators like no lab before. We received our first FDA clearance this summer.
http://fortune.com/2015/07/02/...
it has not been, and still isn’t, required to seek FDA approval because of the way its business model works, which differs from those of incumbent diagnostic labs, like Quest Diagnostics DGX 0.67% and Laboratory Corporation of America
Holmes has voluntarily submitted voluminous data and validation studies to the FDA on more than 120 of her tests so far—without any legal obligation to do so—in an effort to persuade that body to grant formal clearance to her methods. She has done so, she says, because she regards the FDA’s imprimatur as the “gold standard” for safety and effectiveness.
In an interview, Holmes says that, because the FDA has today approved the basics of her system in the context of HSV-1 test, she is hopeful that clearances of her other tests will now be occurring at a faster pace.
So you are now saying that HSV is a simple test to get approved, but you don't believe any other tests will be? It takes time to get FDA approval, but funny, this company doesn't need any approvals, they are doing them voluntarily, which no other lab is required to do, hospitals don't have to get their tests approved by the FDA, so why is Theranos any different?
APK likes to ask for responses to the same things over and over. Maybe he just likes the responses?
I'm quite sure you are closer to homeopathy than us. The RDA for vitamin D in America was 200 iu, some % of people require 5000 iu + to have adequate blood levels, as just one example. How about you? There are cheap, effective cancer drugs unavailable in the US under the FDA because they are too nice, literally not nasty enough. Saves a bundle, feels good and extends survival more than their way overpriced US counterparts.