The company is all hot air. They have a board full of retired military figure heads that have no experience in medical devices or retail services. Additionally, they do not have any products to show. Look at their patents. They are all very general and broad. There has been NO FDA CLEARANCE for anything they are doing, which raises legal questions. Speaking of legal, search for lawsuits they are involved in. Their core technology is not even theirs. They stole it from someone else.
I would tend to agree. Nanomix (nano.com) has been trying to accomplish this for the past ~6 years or so. Combining a complex biological assay + micofluidics + high precision sensing technology is not a trivial task. I want to see some hard data verified from a third party.
While I have no idea if any of the other claims are true, it's important to note that they do claim to be regulatory-cleared (not FDA, not relevant in this case): they claim to be running a CLIA-certified lab.
CLIA (Clinical Laboratory Improvement Amendments)[1] defines the regulatory standards for clinical labs which take in samples and perform medical tests on them. It works very differently from FDA drug or device approval. Most often the certification is done by an organization such as the College of American Pathologists (CAP), which scrutinizes a lab's protocols and output[2].
In any case, if they are CLIA-certified they are open for business, legally speaking.
The only lawsuit information I've found so far shows Theranos as the plaintiff, represented by Boies Schiller & Flexner LLP. That would be David Boies, fwiw.
Theranos is a medical laboratory that appears to have developed new methods of measuring lab values in small sample sizes more quickly. This is interesting because it means that instead of a traditional blood draw with a needle and vial requiring a trained phlebotomist and healthy veins, physicians can use blood collected from a finger stick -- a far less invasive and painful procedure. Additionally, it appears that they've managed to keep costs very low by automating everything -- this also improves their accuracy. I would love to get a look at their technology and implementation. From a biogeek's perspective this is insanely great.
Does this mean that I'll be able to walk in and order my own blood tests in the US, without being extorted by a doctor? I see zero reason for me to be forced to schedule time with a doctor, pay her, just for her to "order" tests and have the results sent only to her, and then pay her again to read them back to me.
I get regular liver checks due to medication I take. Being able to walk into a lab and download the results online is a great convenience, but not something allowed in the US at the moment (to my knowledge).
You can already do that, through lef.org, among others. You get a discount on the tests if you pay for a membership with the site, but it doesn't appear to be necessary.
(I'm neither a member, nor a customer, but I stumbled across their site a while back, doing some research about a health issue I ended up not having, anyway...)
I can get any blood test I want in Poland, everyday, as long as I pay for it. You need a prescription for procedures like X-rays, which have possible adverse effects, or for blood tests if you want them to be covered by the state health insurance.
Their website said you still need a doctor's note. It would be nice to avoid that in the future, I'd get cheap tests done all the time just out of curiosity.
This comment looks strange to me. While I'm pretty new in the US, I find the exact procedure you're describing quite easy. All I need to do is leave an online message for my doctor asking to prescribe the test. They usually answer within hours - and I can go to the nearest lab. That, of course, given that I actually need these tests done and don't just fall on my doctor out of the sky. It sounds like you have a known condition so the doctor should have no problem figuring out why you're asking for a test.
There are companies that take orders directly from patients and provide results back directly as well. Just google for "online lab tests" and look at the top few. They go through a doctor, but they basically rubber stamp the test order. They don't typically provide interpretation services nor are they covered by insurance (afaik). They do however, return results to you as soon as their back from the lab and typically work with labcorp or quest so you probably won't have to change your routine.
This capability depends on your medical care provider in the US. I know that Sutter Health and Kaiser are both providing patients with systems where they can see their lab results on the web, along with all of their medical history. Reaching out to your doctor via email is even included. It works pretty well in my experience (Sutter).
You're paying for her expertise in reading the results and making a diagnosis. Sure, the Theranos charts come back with indicators that show if your values are "normal" or not, but if your health situation is complex, self-diagnosis might be a bad thing.
"We believe access to accurate, affordable, real-time diagnostic information is a basic human right."
There's a bit of a conflict-of-interest if the company that makes money providing "X" declares that "X" is a basic human right. Even as a non-profit (most hospitals are non-profit, but that just means the corporation doesn't keep earnings), you can't justify that statement.
Agreed, although I don't mind so much whether they are making money off it- anyone making money off promoting freedom of speech is welcome to promote free speech as a human right.
But there's an issue of basic human right inflation thats slightly distasteful. Freedom of speech, freedom of religion, freedom to own property without it being arbitrarily taken away for you by someone stronger. Those are basic human rights, and they don't have to be provided at someone else's cost.
I'm a strong supporter of an individual right to healthcare, provided by society/government, but that's a right agreed by social contract... Saying it in stronger terms risks devaluing in a a real way the more basic rights, which billions of people don't have.
Maybe I'm being pedantic given that this is PR copy...
Edit: carbocation said this 15 minutes ago, oops, upvoted
Yes, positive rights that have real cost associated with them–rights which require that someone else do something for you–seem more like "part of the social contract" rather than a fundamental right.
Also, this company states it will still require doctors' orders so not sure how that squares with the rights talk.
You just have to ignore the "basic human right" stuff. Generally it just means "something we think a lot of people want," but phrasing it this way can comfort people who think that profit motive is evil (despite the fact that it seems to be the most economically efficient way to distribute resources).
What they mean is that they want to provide testing in such an easy, affordable, useful way that it can become a basic human right/the standard. It is similar to how literacy could become a basic human right once books became cheap, accessibly written and easy to distribute. Should the company that brings about this change be able to expect people to demand its (and its competitors') services? That is what you are asking. I think it depends on if the new standard is actually a positive change. Since the new testing process seems in every way superior to current standard processes, I think that the change in behavior Theranos proposes to bring about is a healthy and beneficial one, and do not mind that they have the means to provide what they want to exist.
I don't necessarily disagree with you, but if a real estate agent claimed 'Shelter is a basic human right' in their marketing - would that constitute a conflict of interest? What about Evian adding 'water is a basic human right' to their labels?
The environment in which Theranos operates is highly regulated, often to the benefit of entrenched/concentrated incumbent providers rather than consumers.
So throwing in a little reminder that a cheaper/faster/on-demand offering has a 'right-of-access' dimension may be useful, as a balance against any FUD/appeals-to-traditional-gatekeeper-authority, coming from other slower/higher-cost providers.
They do say the right is for "access to...", rather than for "free provision of...".
People who make these statements don't fully understand what they are typing. I feel like in the modern English language, you almost have to over emphasize just to get your basic point across.
the pictures of the people kind of creeps me out. the technology sounds great but the website design kind of gives me a half life feeling... like if I give them my blood next thing we know I'll be walking around like a zombie.
besides that - website looks great. It would be great if my kids did could only have to deal with a finger prick to draw blood... definitely one of my worst memories growing up.
So, it's a health testing company that will keep all my blood-related health information and make it "actionable", with the backing of James Mattis, William Perry and none other than Henry Kissinger. There are more soldiers in that board there than doctors.
The only way I'd give them my blood would be to infect them with a disease.
Wow. That board of directors is a sight to behold. Looks more like a panel at the World Economic Forum. How on earth did the founder manage to get such high-profile backers?
They seem to have dropped their big map marker right on top of Agilent (between 280 and Lawrence in Santa Clara). If you do a search for 95051 (that zip code), it eventually tells you there are no locations there.
I wonder what the significance of that marker is, then...
Seems like an ease/cost breakthrough for health-monitoring... so I'm surprised they picked a name that sounds so much like 'Thanatos', the Greek god of death.
It's always been a gamble. If you achieve even a modicum of success or notoriety, your "drop out" status becomes incredibly valuable. You're a trailblazer, a rebel who blew past convention on her way to glory.
If you fail, you're an arrogant idiot who thought she was too cool for school.
What's fascinating about Holmes is that she's a drop out in the biotech/health care realm. This has long been considered a protected area, one where heavy education is a must, as lives are on the line. Founders are expected to be PhDs or MDs with decades of research and/or clinical experience.
Holmes has a decade of experience, and no degree. This is going to be a lot of fun to watch.
Interestingly some of their jobs for software engineers require "B.S. degree […] one of the World's Top 50 ranked Technical Universities". Other jobs like the Android position require a BS degree. It seems a little odd to require a degree after deciding you don't need one yourself.
Just today, I was just searching around for a way to order my own Quest lab tests here in the US. (I'm on the East Coast, Theranos doesn't seem to have locations here)
Does anyone know of any e-doctors that will provide me with lab orders on my behalf? I've seen WellnessFX, but I want to order Quest panels for things they don't offer in their package. Who else is doing something similar to them?
I've been waiting so long for this. As someone who avoids syringes like the plague, I always wondered, how come we have robots in Mars, yet we can't come up with something better than injecting a large piece of metal into our bodies? Now I just need to find a way to give them my money.
Strangely designed web-site. When you open it you don't understand what they provide. Is it a service, app, or idea? Device or standard? Then while clicking through sections you see some clipartish generic-looking pictures of people and ipad screens. Only the small vial with blood promises some useful information but no descriptive text or images provide any detail (why this small vial is better and experience is less painful than generic tests?). So after skimming the site reveals nothing you get irritated and leave. There's so much interesting things on Hacker News. Maybe those guys are changing the world but their web-site does not convey it.
I think the intent was to show how humane and globally thinking they are, by showing different ethnic races.
But to me it looks as if they want to hoard blood-samples for a DNA-Database in order to clone the best of us into super-soldiers. If the military has a DNA-Database of every human on the world they think are worth living, they could wipe all of us out, then re-breed the world to their own likings. I think some billionaires would love this sick sick idea.
[+] [-] medman77|12 years ago|reply
[+] [-] rloomba|12 years ago|reply
[+] [-] spartango|12 years ago|reply
CLIA (Clinical Laboratory Improvement Amendments)[1] defines the regulatory standards for clinical labs which take in samples and perform medical tests on them. It works very differently from FDA drug or device approval. Most often the certification is done by an organization such as the College of American Pathologists (CAP), which scrutinizes a lab's protocols and output[2].
In any case, if they are CLIA-certified they are open for business, legally speaking.
[1]: http://wwwn.cdc.gov/clia/ [2]: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_act...
[+] [-] perchance|12 years ago|reply
[+] [-] gnoway|12 years ago|reply
Are there others?
Edit: Here's some background: http://www.leagle.com/decision/In%20FDCO%2020121203541
[+] [-] unknown|12 years ago|reply
[deleted]
[+] [-] justinjlynn|12 years ago|reply
[+] [-] MichaelGG|12 years ago|reply
I get regular liver checks due to medication I take. Being able to walk into a lab and download the results online is a great convenience, but not something allowed in the US at the moment (to my knowledge).
[+] [-] rosser|12 years ago|reply
(I'm neither a member, nor a customer, but I stumbled across their site a while back, doing some research about a health issue I ended up not having, anyway...)
[+] [-] jwr|12 years ago|reply
I can get any blood test I want in Poland, everyday, as long as I pay for it. You need a prescription for procedures like X-rays, which have possible adverse effects, or for blood tests if you want them to be covered by the state health insurance.
[+] [-] heurist|12 years ago|reply
[+] [-] beagle3|12 years ago|reply
[+] [-] eliben|12 years ago|reply
Time to change your healthcare provider, maybe?
[+] [-] justinjlynn|12 years ago|reply
[+] [-] spartango|12 years ago|reply
[+] [-] chiph|12 years ago|reply
[+] [-] kennystone|12 years ago|reply
[+] [-] smoyer|12 years ago|reply
There's a bit of a conflict-of-interest if the company that makes money providing "X" declares that "X" is a basic human right. Even as a non-profit (most hospitals are non-profit, but that just means the corporation doesn't keep earnings), you can't justify that statement.
[+] [-] nohuck13|12 years ago|reply
But there's an issue of basic human right inflation thats slightly distasteful. Freedom of speech, freedom of religion, freedom to own property without it being arbitrarily taken away for you by someone stronger. Those are basic human rights, and they don't have to be provided at someone else's cost.
I'm a strong supporter of an individual right to healthcare, provided by society/government, but that's a right agreed by social contract... Saying it in stronger terms risks devaluing in a a real way the more basic rights, which billions of people don't have.
Maybe I'm being pedantic given that this is PR copy...
Edit: carbocation said this 15 minutes ago, oops, upvoted
[+] [-] carbocation|12 years ago|reply
Also, this company states it will still require doctors' orders so not sure how that squares with the rights talk.
[+] [-] baddox|12 years ago|reply
[+] [-] 1123581321|12 years ago|reply
[+] [-] binarymax|12 years ago|reply
[+] [-] gojomo|12 years ago|reply
So throwing in a little reminder that a cheaper/faster/on-demand offering has a 'right-of-access' dimension may be useful, as a balance against any FUD/appeals-to-traditional-gatekeeper-authority, coming from other slower/higher-cost providers.
They do say the right is for "access to...", rather than for "free provision of...".
[+] [-] unknown|12 years ago|reply
[deleted]
[+] [-] rfnslyr|12 years ago|reply
[+] [-] unknown|12 years ago|reply
[deleted]
[+] [-] gojomo|12 years ago|reply
Faster/cheaper blood-testing, via a smaller/quicker samples (a fingertip-prick rather than needle-stick).
[+] [-] ott2|12 years ago|reply
[+] [-] noir_lord|12 years ago|reply
It's a pretty looking website though.
http://www.xconomy.com/san-francisco/2010/07/08/theranos-rai... actually made it a lot clearer than their website did.
[+] [-] taf2|12 years ago|reply
besides that - website looks great. It would be great if my kids did could only have to deal with a finger prick to draw blood... definitely one of my worst memories growing up.
[+] [-] unknown|12 years ago|reply
[deleted]
[+] [-] jkuria|12 years ago|reply
A real game changer I think.
[+] [-] dlisboa|12 years ago|reply
The only way I'd give them my blood would be to infect them with a disease.
[+] [-] gjkood|12 years ago|reply
Former heavyweights in the diplomatic, intelligence and military government sectors (George Shultz, Senator Samuel Nunn, Henry Kissinger etc).
No big names from the technology or VC space are mentioned however.
Something big is brewing.
[+] [-] redschell|12 years ago|reply
[+] [-] aheilbut|12 years ago|reply
[+] [-] rachelbythebay|12 years ago|reply
I wonder what the significance of that marker is, then...
[+] [-] fosap|12 years ago|reply
- Oncology - Pediatrics - Geriatrics
Yeah. Would you go to a doctor that is specialized on "cancer and stuff"? I wouldn't. This is as unspecific as one can get.
[+] [-] gojomo|12 years ago|reply
[+] [-] benrapscallion|12 years ago|reply
[+] [-] redschell|12 years ago|reply
If you fail, you're an arrogant idiot who thought she was too cool for school.
What's fascinating about Holmes is that she's a drop out in the biotech/health care realm. This has long been considered a protected area, one where heavy education is a must, as lives are on the line. Founders are expected to be PhDs or MDs with decades of research and/or clinical experience.
Holmes has a decade of experience, and no degree. This is going to be a lot of fun to watch.
[+] [-] MarkSweep|12 years ago|reply
[+] [-] cypherpunks01|12 years ago|reply
Does anyone know of any e-doctors that will provide me with lab orders on my behalf? I've seen WellnessFX, but I want to order Quest panels for things they don't offer in their package. Who else is doing something similar to them?
[+] [-] sker|12 years ago|reply
[+] [-] beyondcompute|12 years ago|reply
[+] [-] realo|12 years ago|reply
Creepy.
[+] [-] X4|12 years ago|reply
But to me it looks as if they want to hoard blood-samples for a DNA-Database in order to clone the best of us into super-soldiers. If the military has a DNA-Database of every human on the world they think are worth living, they could wipe all of us out, then re-breed the world to their own likings. I think some billionaires would love this sick sick idea.
[+] [-] fallingmeat|12 years ago|reply
[+] [-] unknown|12 years ago|reply
[deleted]