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.
This board seems heavily geared to do deals for defense-related applications. That's fine; getting deals with the Armed Forces and VA is feasible and quite rewarding.
What they overtly lack is connections to the healthcare world. I'm surprised they aren't publicly roped into Cleveland Clinic, Mayo Clinic or Kaiser, as they to support novel technologies in this space. I suppose you can argue that the business model is fundamentally incompatible, but I've seen Mayo and Kaiser go in anyway; they can acquire these labs and roll them into operations pretty easily.
Serious question: what economic incentive does the healthcare world have to adopt something like this?
If it's a finger prick, there's less to mark up.
From the outside, it seems like the entire healthcare industry is built on being purposefully inefficient so as to create large costs that they can in turn mark up.
To the VA, inefficiency is a problem. In the healthcare world in general, it doesn't seem to bother anyone.
Kaiser is one example where incentives align, because they're an integrated HMO, running both the insurance and the care side of things. It's kind of like an opt-in single-payer organization. Their model is that they charge you X/month for care, and then everything is billed internally, with Kaiser clinics treating Kaiser plan members. So if they can bring costs down, that helps them; since nobody external is reimbursing for services, there is no advantage to billing expensive tests.
It's all about speed and costs. The finger-prick is a distraction; phlebotomy is not a huge deal.
Instead, the important things are the turn-around-time and billed cost. If Theranos can offer 4 hour turnaround and a clinic/hospital cannot (or even get close), they will pay for it because it is good for doctor productivity and patient outcomes. If Theranos can maintain a half-medicare cost structure, that's also good for the provider because they can expand their margins.
Additionally, Theranos might do deals with insurance companies such that they reduce their reimbursements/push providers to use Theranos, which reduces the insurer's costs. The outcomes-case is even more pressing for an insurer these days.
Now, none of these directly translate to lower insurance premiums, but that doesn't mean that there aren't economic reasons to adopt the service.
> From the outside, it seems like the entire healthcare industry is built on being purposefully inefficient so as to create large costs that they can in turn mark up.
This is generally untrue, as much as it is a public perception. The system lacks simplicity and thus comes across as opaque; this is its failing. Its complexity is not malicious, though.
what economic incentive does the healthcare world have to adopt something like this?
Not much, which is why this service should not be offered through the standard healthcare system. I can see two other ways to do it:
(1) I walk into a drugstore, sit down at the testing machine, select the tests I want, swipe my credit card, and the machine takes a drop of blood from my finger, runs the test, and gives me a printout of the results.
(2) Home testing kits for every common lab test, not just blood sugar.
Note that Quest Diagnostics has a drugstore partnership with CVS[1], directly competing with Theranos+Wallgreens. Labcorp has similar offerings, although some are whitelabeled.
But these tests still require large blood samples, and they have to go back to the lab to be tested, right? So you can't just walk into the drugstore, get tested, and walk out with the results.
The BOD (or "Board" as the company calls it) seems a little strange to me as if she runs in rarified circles. While I'm sure folks of such stature could provide some assistance, I have a hard time believing they are acting under traditional BOD-like activities. And where's the management team or is this a one-person affair?
maybe some sort of outgrowth from rapid triage/battlefield medicine tech? I know there's been a lot of pentagon efforts to figure out how to treat soldiers in the field more quickly, but mostly with trauma applications.
With the volumes they're dealing with and the automation they tout I bet they're using integrated microfluidic chips with built in sensor technology. That's so cool and it makes sense given the time they spent in stealth mode since that's a rather new technology and getting it certified must've taken some time. Looking a patents and bingo, they have patents on microfluidic techniques. Awesome. Eventually they might have a medlab in a box -- neat.
You appear to be interested and aware of the current state of clinical chemistry. Are you aware of any HN/Slashdot-esque sites for this pursuit? One of my main areas of hobbyist interest this year is biochemical assays and health diagnostic mechanisms, but there is a lot of chaff in my google searches.
Any pointers would be appreciated. My email is in my profile if you would like to discuss it more in depth.
I have looked at the DIYBio groups on a number of occasions, and while they are fascinating it their own right, they aren't quite what I am interested in. DIYBio (as far as I can tell) is considerably more interested in DNA sequencing and genetics, whereas I am more interested in diagnostic tools for improving my quality and quantity of life.
but my more general question is: how can we do everything a standard blood panel does now, except do it extremely frequently (e.g. daily or hourly or even continuously) and noninvasively or as close as is feasible.
Of course, I know very little about the field, so this might all be the equivalent of "Hey guys, I know a little HTML and I was wondering if I could build a MMORPG..." posts on gamedev, but hey, gotta start somewhere. :D
There's diagnostics for all which is working on paper based diagnostics. They are so cheap , that they target them for the third world. And they only need a blood drop.
Given that they are going up against massive, automated operations like those of Labcorp and Quest Diagnostics ($9B market cap each), they'll probably need this tech to keep up.
While the thumb-prick and low sample volumes are cool, in the grand scheme of patient care they are somewhat gimmicky. Until doctors request higher-frequency testing, this doesn't pinch that hard. Still cool.
The big sign that they need to be wielding novel capabilities to compete with Quest and Labcorp is the offering of their menu at half of the medicare reimbursement rate. Each of those companies run ~40% gross margins off of medicare reimbursement, so Theranos without novel tech would be running a pretty substantial loss.
Low volume samples are important in pediatrics at least (wife a Dr) At the hospital she works all of their samples are low volume already. Plus critical kids get ffrequent samples depending on the level of monitoring needed. For babies you obviously have no choice or they could become anemic. Plus not all kids like seeing a vial fill up.
What about patients wanting higher-frequency testing? What if the test machine were sitting in my local drugstore, and I could go in, swipe my credit card, and have it run a test on a drop of my blood whenever I wanted to?
That's it. No doctors needed. I just chatted to my doctor siblings about this over lunch ... they shot this idea out the water on the premise that it is indeed gimmicky and they wouldn't use it to make any substantial changes to patient treatment based on their results - they'll need "more reliable" testing. I could hardly get a word in! :-)
Except, I kept on saying, maybe the service is offered directly to people - without a doctor's consult.
Hell, what do I know! Nice to see innovation in fields other than information technology though.
I'd say it's more painful than a blood draw if the phlebotomist gets it right on the first stick, less painful if the phlebotomist is going to have to try many times or go for atypical access sites.
I'd be more wary of potassium and other electrolytes, but it would be interesting to see a comparison to venipuncture.
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.
Yes, I'm not sure about the types of tests that are done but if there are some that you could run periodically to compare numbers, it might prove useful to monitor how one's body changes over time.
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
Who grants basic rights? If they're God-given, perhaps they're immutable. Nature grants no rights, and is perfectly willing to stand by idle while we slaughter each other by the millions.
The alternative is that basic rights are agreed upon by the society, and as the society matures and evolves, why shouldn't its understanding of what basic rights are change?
They're certainly not immutable, and do not exist outside of the context of a society. If you're alone, you have no rights whatsoever; they're something we "recognize" (or not) in other people.
The language we use is probably based on ideas that they supernaturally-granted or something like that... which is silliness, but I don't think we should change the habitual phrasings... people are more likely to treat each other humanely if they believe that rights are, you know rights, and the language encourages that.
Do rights change, or does the expression of a right change? I believe everyone has a right to an education. Obviously that education will have changed from 4000BCE to 2013. What about the right to create and choose family? How does that intertwine with society's thoughts about homosexuality?
I guess a good answer to that question would be a PhD dissertation, not a HN comment. I wish I knew the answer, or that it was easy for me to express.
I guess a good answer to that question would be a PhD dissertation, not a HN comment. I wish I knew the answer, or that it was easy for me to express
Very true :) we are not the first to discuss this. Nor is it the first time a legitimately interesting HN post about technology has turned into a side debate about quasi-libertarian philosophy.
"Rights" are the repackaging of religion for the secular age[1]. I know this is controversial because it is heretical, but consider the correspondence. Rights have no physical existence, only a social existence. Rights only matter through the exact same mechanisms that the wrath of Allah matters - if enough people believe in it and are motivated by it then it has force. In the past, Christian missionaries spread religion to the world with books, words, charity, and occasionally the sword. Today, the post-Christian West spreads human rights to the world through dollars and bullets (the carrots and sticks of foreign policy).
By imagining new human rights, a corporation marks themselves as a member of the ultra-religious, sort of the pharisees of our day. Not only do they obey God's commands, but they invent new commands to follow and by this show off their righteousness. Yes, this stance is made to atone for the sin of making profit - which is a minor sin in the West - "it is easier for a camel to pass through the eye of a needle than for a rich man to inherit the kingdom of God" after all. Do not be mislead, liberalism (including the "classical liberalism" of Locke and Jefferson) is Christianity without God. Jefferson's Bible makes the point explicit.
Making new human rights is good business. A college education became a human right sometime in the last 50 years and today over $200 billion is spent on tuition each year in the USA alone. Yes, it is disingenuous, but also quite clever, for a corporation to position their product as a new human right.
Even the negative rights (freedom of speech, rights to property, etc.) require the positive right to protective services for those rights to have meaning. If we examine the history of such rights, we find they are rooted in English tradition. Essentially the modern idea of human rights is an idealization of 18th century English law. But "human rights" philosophy gives that law a mystical existence and rightness aside from the specific historical balance of power that led to its creation.
[1] What follows is ripped straight out of Nietzsche and Moldbug. Grazie, signori. I can recommend Moldbug's masterful trilogy on Idealism, which includes the weird new atheist religion-like philosophies:
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.
Before books were inexpensive and widely distributed, other means of communication fulfilled many of the functions of books. That is why I chose that example. If you believe that literacy is an eternal human right, substitute one of the other more economically dependent ones such as the right to a lawyer. I don't want my analogy to get in the way of my point for you.
That makes sense. I'm not sure positive rights such as the right to a lawyer, or the right to police protection, are fundamental human rights. If you draw a distiction between positive and negative liberty a la Kant [1], you can argue that only negative liberties can be basic human rights. Sure we have a right to legal counsel, but that also implies a duty. What if no one in the city wants to be a lawyer.
Was literacy a human right before humans invented the first written languages? What about the first few thousand years afterwards, where it was a technique used only by specialists and the materials to write were very expensive?
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.
Just recently I had a visit at an allergist and found the entire procedure so primitive, that I nicely informed the doctor that they could upgrade the way they do tests. I or anyone else technically minded could very easily come up with less prehistoric tools, but he was as expected not interested in any improvements. I hate school-medicine.
Thanks for the background info, it's always worth to know who is behind something. Even the best thing that can happen to humanity would be abused, if supported and financed by sick minds.
My experience in the space is that this is a mischaracterization of the FDA, but also misses an important point:
Theranos does not fall under the FDA's mandate in its current form. It is a CLIA-certified laboratory operation, regulated under CDC rules and scrutinized most likely by the College of American Pathologists(CAP). The CLIA/CAP scrutiny is very different from the FDA device/drug process, focusing on protocol and output. Even if they have novel technology, it is often classified as a laboratory developed test(LDT) and falls outside of the FDA's mandate (for now).
Many startups have achieved CLIA-certification without too much difficulty, from Foundation Medicine to Veracyte to Counsyl. It's totally reasonable and doesn't take too long.
With that kind of firepower (no pun intended) Ms. Holmes may be setting her sights on the larger World market. Lots of people to be helped beyond the borders of the USA.
Could she become the Elon Musk of the healthcare sector?
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...
I was going to write a response adding that adding a picture of the actual location would've been just as easy, instead I made a post about how I was going to make a post about how ready it'd be to use a snapshot of the actual location.
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.
It sounds like she dropped out in 2003 to work "in biotech" so she's probably working on this for the past decade. That she's gotten to this stage is pretty impressive - considering the board, plus the "careers" page and the type of folks they're looking for right now looks like they're off and running
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.
idk, but it appears like it really is and most importantly it is very important to know where someone is coming from. Finding a high profile company/institution and dropping out, because you can do better without them shows ego and attribution.
Most billionaires dropped out and became billionaires then.
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.
I assume the image of the micro-vial balanced on a fingertip is meant to illustrate how small the quantity of blood is, but, at least for me, the initial evocation is of drawing blood from beneath the fingernail.
When I was in South Korea a while back I was able to get a blood test via a finger prick and the results back before I left the clinic that day.
Admittedly, the chap at the clinic did think I had hepatitis, but apparently that can be explained by the excessive amount of whiskey I had consumed the previous day.
their patents portfolios seems huge with 17 issued and mostly covered microfluidic diagnostics. one of them is titled "Real-time detection of influenza virus" (US 8,007,999). it would be really disruptive if they could do their claimed 1000+ lab tests with their proprietary microfludic devices in under 4hr.
With a board like that they'll probably get a lot of VA /Medicare /Medicaid contracts and swim on cash. But then Labcorp etc will fight back, they already offer deeeeep discounts for Aetna and other major clients (seen $7 for them, $100+ for cash payers.) Also on top of my head, I can think of newborn screening, that is all done via heel prick, so the tech exists.
Unless the business plan call for a free first test for everyone in USA...sponsored by NSA ;)
