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I think I'd really like to see the actual numbers on that thing and am pretty skeptical.
 

LADoc00

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Will suffer the exact same fate as 23 and Me. Hence why they have been hiding in the shadows. All it is a point of care analyzer, of which there are dozens of models already in the market. All they are doing differently is microsampling.

Also the board of directors looks more like a team to negotiate peace with Iran rather than an actual biotech board. That and the founder has essentially no real lab experience whatsoever and not the slightest about JCAHO, proficiency testing and CMS etc.

But hey she is young and hot and that will definitely allow you to take peoples' money.
 
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Will suffer the exact same fate as 23 and Me. Hence why they have been hiding in the shadows. All it is a point of care analyzer, of which there are dozens of models already in the market. All they are doing differently is microsampling.

Also the board of directors looks more like a team to negotiate peace with Iran rather than an actual biotech board. That and the founder has essentially no real lab experience whatsoever and not the slightest about JCAHO, proficiency testing and CMS etc.

But hey she is young and hot and that will definitely allow you to take peoples' money.
LA, playing devil's advocate here, isn't comparing 23 and Me and Theranos sort of apples and oranges? Theranos is offering standard testing by physician order whereas 23 and Me is selling genetic data of sometimes uncertain significance direct to the consumer.

I don't know how Theranos can offer testing that cheaply. People are in a tizzy about it here.
 
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2121115

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Now that clinical lab tests are getting bundled - see ya Theranos.
 

WEBB PINKERTON

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I dont see how Theranos is going to do much business with all the physician offices being bought up by hospital chains. Who will refer patients there, especially considering physicians make money off of lab testing? They also expect results to go into an EMR. Isnt that beyond Theranos capability?
 
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2121115

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Theranos will go the way of most other clinical lab testing - commodity, low reimbursement, etc. I don't know any pathologists that are concerned about it. People who think pathologists should be concerned don't really understand what we do.
 

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I'm on like 3 or 4 other pathology listservs and Theranos discussions have been filling up my email. Their ultimate goal seems to be allowing patients to order their own lab work. I guess I am old school and still think it should be physician-directed.
 

2121115

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I'm on like 3 or 4 other pathology listservs and Theranos discussions have been filling up my email. Their ultimate goal seems to be allowing patients to order their own lab work. I guess I am old school and still think it should be physician-directed.
Even if patients do order their own Theranos lab work, so what? I just don't see the issue here for pathologists. Unless you are component billing CP tests, there is no big deal here. And if you are, that is going away soon anyway.
 

turtle1966

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CP that the likes of Theranos offer is a return on "capital" and not on our labor, so I would say we have no "dog" on this fight.
 

yaah

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Most of the media on this has been disappointing mostly because it presents an extremely inaccurate portrayal of labs. That it takes days to get results. No, it takes a few minutes. The time is comparable if not superior to what they say Theranos does. The time is often long because of delivering the result to the physician or delivering the specimen to the lab, both of which are not really the point. They say you can run many tests on one sample but you can't in regular labs. Not true at all. There are different tubes for different specimen types but you don't need to redraw to run another test for most things that are related to the original order.

The most notable things in this are the cost (which is mostly an artifact of current reimbursement strategies and lab "pricing" methods and may not be such a huge advantage).

If this truly is a revolutionary technology I would suspect someone like Beckman or Siemans or whoever would buy it and market it.
 

WEBB PINKERTON

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A patient's experience at Theranos. Yea, this sounds very revolutionary to me.......

http://decibio.com/blog/theranos-small-sample-big-opportunity/

Need doctor's order.... sample is sent to another facility...... the author had to have a standard blood draw......

I guess if you keep saying you are revolutionary some people will believe it is true. Like this author.... Hasn't this person ever had a blood draw anywhere else?
 

2121115

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Theranos is DOA. No news here.
 

WEBB PINKERTON

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I thought that patient experience was really funny. You could tell the author had drunk the kool aid. There was NOTHING different about Theranos compared to what already exists.
Doubt I will be getting my PT/INR done there anytime soon. Some pretty good looking young phlebs at the lab I go to now. :love:

Glad the government is going to crack down on lab developed tests. My fear is that the lab industry is turning into the wild west and garbage like these people are trying to play in the cesspool.
 
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I keep hunting around trying to see what the big deal is. Who cares? I read a comment from after one of these articles from a woman who had a reason to like this "we stick you for fewer drops of blood" nonsense, she didn't like watching her extremely sick hospitalized child get stuck repeatedly. Bc it made her sad.

Ok, I get that. So next time her child is sick enough to be in the hospital , maybe instead she can go to Walgreens instead and order what tests she wants, so they use less blood. And then she can decide together with the pharmacist and the pharmacy tech whether or to to hospitalize her child. Oh wait.....

A friend of ours just quit her job as corporate counsel for theranos. She said the gal in charge is pretty strange. Doesn't even want employees to talk to each other about the company, all is very secretive. Wouldn't even discuss direction or anything with her own corporate counsel. So our friend couldn't help, got frustrated and quit.

Sounds like the emperor has no clothes.....

In true VC fashion, the sillier the idea, the more money you can get. Facebook for cats, anyone?
 

yaah

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The "few drops of blood" thing also becomes less relevant the sicker the patient gets. Patients who are edematous, for example, will not give very accurate results on finger stick testing. Will reference ranges change? How would they compare to venipuncture?

I still haven't really read anything about this technology that suggests it is truly revolutionary. The one thing that is appealing is that it can run many different tests on one platform, which could be cost saving (but might not be, depending on how much everything costs). Doing tests on less blood is only really helpful for very sick patients, and as said above you often still need a venipuncture for those patients. But all of the things I have read about getting results to patients, getting results faster, ordering tests, running multiple tests on the same sample, etc, are not comparisons to reality. They are pumping up Theranos based on a comparison to a really terrible and crappy lab. What kind of lab takes a week to get you results for a lipid panel?

It may be good if it can spur hospitals and labs to more effectively use existing technology. A lot of this is (not so) simple IT, which theranos is not going to solve unless they have their own information system that can interface with everything.
 
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BlondeDocteur

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It takes a week for you, the layperson, to *hear* the results of your lipid panel in the old-fashioned conventional model. Not for it to be run, not for the results to be communicated to the ordering provider, but for it to cycle back to the patient. Even now in EMR systems where patients can access their own health info (most big hospitals), results have to be released by the ordering provider in most systems so nothing truly terrible makes its way out there before someone can interpret it and warn the patient of its significance. What she is proposing is taking the interpretation out of the loop and immediately uploading the results to a patient-accessible EMR, which I find alarming but probably inevitable.

The media is fawning, fawning, fawning all over her. She strikes me as a narcissist who genuinely believes she's Bill Gates and Albert Schweitzer rolled into one. I wasn't surprised to hear of your friend's take, @pathperson.
 
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WEBB PINKERTON

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My PT/INR results are available online as soon as the test is run. The lab has a website that patients can use to access results. When my physician office finally gets around to calling me, I already have results and have altered my Warfarin dosage if needed.

There is NOTHING revolutionary about Theranos. Good luck to them getting any referrals. What doctor is going to trust sending patients to a secretive company running a bunch of lab developed tests? Someone also needs to tell Theranos that physicians REALLY enjoy profiting from lab work. Better go back to the drawing board and find a client billing scheme. Labcorp and quest could care less about this company.

I love how they are using all the catch phrases like "Personalized Medicine" and "Patient-centered". The stupid media just eats it up.
 
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Their theranos website is just nutty. At the bottom it says, "we believe access to accurate, affordable, real-time diagnostic information is a basic human right."

I LOVE THIS!!! So if I'm a pathologist, and I refuse to use theranos, even if it's faster than my own lab, I'm denying zillions of people their basic human rights!!!!!

If you live in a forest and you have no theranos and no pathologist of any kind, your human rights are also being violated! There's no theranos where I live!! Call the press and amnesty international!

My opinion of that sentence would violate some rules here I'm sure, so I'll just say those people need to think harder. Much harder.

My generation isn't too smart sometimes. Sigh.

Anyway my very favorite article is the one in Fortune magazine. An oncologist says why they think theranos results can't be trusted. Her response? Peer reviewed articles with their validation studies would be unnecessary and inappropriate.

I know we don't have to publish such papers in journals, but if I were trying to take down an entire industry with my "disruptive" technology, I sure would.

Basically her argument is that bc they manufacture their own analyzers and use LDTs, they don't need FDA approval for anything. But I've also read they're going to get FDA approval for their LDTs. Which still doesn't answer about their analyzer problem.

She won't let anyone look at her cool analyzers. Secret!! Except Henry Kissinger. Maybe he gets to see the analyzers.
 

yaah

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Yeah, if they are giving people their results quickly (which many labs also do), then who is going to explain these results to them when they complain and don't understand the results? Agree with the above, this is a somewhat disruptive technology but not radically so. A lot of the things she is presuming are problematic for reasons other than the existing technology. All well and good to change them, but you also don't need a new type of analyzer to do them.
 
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malchik

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Their theranos website is just nutty. At the bottom it says, "we believe access to accurate, affordable, real-time diagnostic information is a basic human right."

I LOVE THIS!!! So if I'm a pathologist, and I refuse to use theranos, even if it's faster than my own lab, I'm denying zillions of people their basic human rights!!!!!

If you live in a forest and you have no theranos and no pathologist of any kind, your human rights are also being violated! There's no theranos where I live!! Call the press and amnesty international!

My opinion of that sentence would violate some rules here I'm sure, so I'll just say those people need to think harder. Much harder.

My generation isn't too smart sometimes. Sigh.
This isn't just your generation. If you polled the US and asked how many believe healthcare is a basic right, at least half the country would respond affirmatively.
 
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I've thought about it a lot, and I just can't get there. Health care is not a basic right. It just..isn't. And this is from a person with people close to me who have had very bad things happen to them health-wise. Health itself, sure...maybe. Not sure what I mean by that. But health CARE? I just cannot get there logically.

If it were a right, people wouldn't have to demand it from other people. If it were a right, you would be born with it, and if you don't have it, it would be because other people are denying you your rights. I am not denying anyone anything if I refuse to work for them. If it were a right you would never have to say thank you. Your doctor would not need compensation or thanks for staying late, taking extra time to see you, etc.

What if I get into med school and I refuse to go, because I am lazy? I am denying people their right to health care? If it is a right, why trust individuals to decide themselves who is best suited to apply to med school? Why not have a higher authority choose who gets shuttled into which professions from a very young age?

I'll stop bc you can all see where this is headed.

I hesitate to even write all this bc some well-intended fool will surely jump down my throat immediately. Ready...set...pounce!
 
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yaah

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Theranos is looking for a lab director, as advertised on path outlines.
 

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It's funny watching a company call itself revolutionary and then try to become like Labcorp/Quest.......Good luck with that. It will be pretty expensive to build the same infrastruture they already have and charging "client bill" prices. What exactly is the pull through business to make some money?
 
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rollwithit

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Exactly. Goods and services that have to be provides by others cannot be rights. You have a right to pursue accessing healthcare, but you have no right to force someone to provide it to you. I have the right to become a salesperson or actuary before training myself to provide medical services. Forcing me to do so violates my right to live as I please (i.e. Pursue happiness).

Now, does a wealthy society have a self interest in providing reasonable access to quality healthcare to all citizens? That's the better question. Claiming it a right is just the lazy way of going about it.
 

malchik

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Exactly. Goods and services that have to be provides by others cannot be rights. You have a right to pursue accessing healthcare, but you have no right to force someone to provide it to you. I have the right to become a salesperson or actuary before training myself to provide medical services. Forcing me to do so violates my right to live as I please (i.e. Pursue happiness).

Now, does a wealthy society have a self interest in providing reasonable access to quality healthcare to all citizens? That's the better question. Claiming it a right is just the lazy way of going about it.
But it is more than just a lazy way of saying it is a reasonable good. If something is framed as a right it carries weight and demands government protection. I'm not sure if the average American is as thoughtful as a post and just doesn't know the difference, or if the single-payor lobby is quite clever for framing it as a rights issue, or both. Sorry for straying from topic.
 
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awesome, theranos works. this is how blood work should always have been performed. this will definitely be a good thing.
 
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yaah

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It's funny watching a company call itself revolutionary and then try to become like Labcorp/Quest.......Good luck with that. It will be pretty expensive to build the same infrastruture they already have and charging "client bill" prices. What exactly is the pull through business to make some money?
I suspect their intended market will be pharmacy clinics, outpatient clinics, and such. More like Quest as a point of care thing. So in a sense they want to be a massive POC operation. This is going to be difficult in terms of regulation, I would think. Rules for POC are getting more and more onerous. If they want to have a central lab where people send their specimens...good luck with that. With labs like that the major hurdle for TAT is transport and unless they are planning to revolutionize the transport system (which would be fascinating but have nothing to do with their technology) that tactic obviously is a non-starter for being revolutionary. They may improve TAT on some tests which are historically batched at larger reference labs, but most of those tests are not stat anyway.
 

WEBB PINKERTON

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I was under the impression they would be doing a bunch of point of care tests. It looks like to me they are sending specimens to a lab. They even have a phelb doing blood draws instead of finger pricks. Their pricing is close to client pricing for most labs. But as we know, we all offer client pricing with the guarantee of pull through business to keep our doors open. I just dont see how they will make any money or set up the infrastructure to be a threat to the already entrenched labcorp/quests of the world. And no doctor/payer is going to trust sending patients to such a secretive company doing a bunch of lab developed tests. Referrals will be few. Maybe the FDA can clean up the wild west of lab developed testing but i doubt it.

I dont know how you revolutionize the transport system. Drones? It's sad watching Jeff Bezos piss away money on Drones when it will NEVER happen.
 
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yaah

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Yeah, as best as I can tell, the only things that this has an advantage on are:
1) Needs less blood (but debatable how often)
2) Can run more complicated tests on single sample (regular tests probably will develop this possibility too).

As I said, they are comparing some sort of horrible awful lab which drains their patients of units of blood, takes weeks to get results on CBCs and chem panels, refuses to give any results to patients, and charges 1000 per draw. So yes, compared to that, it is revolutionary!
 
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As someone who had read one of the many articles hyping Theranos and its CEO, I found this thread to be very informative. This SDN thread is the first result that Google returns when I type in "theranos skeptical."

I am interested in hearing your opinions on a section from the Fortune magazine article on Theranos. I've pasted the relevant paragraphs below:

What do incumbent players in the blood-diagnostic space think about all of this? The most frequent criticism is that Theranos is using purportedly breakthrough technology to perform tests that are relied on for life-and-death decisions without having first published any validation studies in peer-review journals. “I don’t know what they’re measuring, how they’re measuring it, and why they think they’re measuring it,” says Richard Bender, an oncologist who is also a medical affairs consultant for Quest Diagnostics, the largest independent diagnostic lab.

Holmes counters that because, as noted, her tests employ “the same fundamental chemical methods” as existing tests, peer-review publication of validation studies is both unnecessary and inappropriate.

The backdrop for this dispute is an unusual regulatory structure that does, in fact, confer upon some–though not all–conventional lab tests an extra layer of validation that Theranos’s do not yet have. Most labs, like Quest and Laboratory Corp. of America, perform many of their routine tests using analyzers they buy from medical-device manufacturers, like Siemens, Olympus, and Beckman Coulter. Before those manufacturers can sell such equipment, they must obtain U.S. Food and Drug Administration approval for the tests those analyzers perform–a process that is in addition to, and more searching than, the audits and proficiency tests required to win CMS certification for the lab itself.

At the same time, for other procedures conventional labs will devise their own lab-developed tests, or LDTs, which they do not have cleared by the FDA. While the FDA takes the position that it could require approval for LDTs, for many years it has said it would forgo that right in the exercise of its “enforcement discretion.”

Theranos, which does not buy any analyzers from third parties, is therefore in a unique position. While it would need FDA approval to sell its own analyzers to other labs, it doesn’t do that. It uses its analyzers only in its own CMS-certified lab. All its tests are therefore LDTs, effectively exempt from FDA oversight.

Holmes sees no basis for criticizing Theranos for acting within this framework, since no other labs seek FDA approval of their own LDTs. “Existing labs use thousands of assays that are neither FDA approved nor peer reviewed,” she says, referring to their LDTs. (In fact, the American Clinical Laboratory Association, the trade group for traditional diagnostic labs, adamantly opposes any effort by the FDA to start requiring approval of LDTs and even takes the position that the FDA lacks legal authority to do so.)

Do people here think that the traditional diagnostic labs will now want to have FDA approval for their LDTs? Thanks for any insight on this.
 

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Does anyone have any experience with Theranos? Curious about their technology and what actually makes them different other than using smaller amounts of blood than the other labs. Love to hear any thoughts or perspectives from anyone on here.
 

yaah

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They say that "peer reviewed studies aren't needed" but they sort of are. These test results are important and unless you are going to rely on "confirmation" for anything that is leading to a critical treatment decision (which would make it not very useful) there needs to be validation. Hell, when we transfer machines from one offsite lab to another we have to document extensively that the results are real and concurrent. No one is just going to take our word for it because we say so. If this technology becomes mainstream they are going to need to show their data - what the standard deviation is, how the results relate to other commonly performed assays, how the assay performs when repeated multiple times. I am not sure how they are going to get any legitimate business if they don't do these things.

I really don't know what to think about this issue. I can't tell whether so many of the problems that I see are the result of incompetent media reporting or exaggeration or are because the company itself has a poor grasp of regulatory and technical issues regarding the current lab market. If this truly is a revolutionary technology, it seems to me their business would be at replacing the current lab systems like siemens, beckman, etc because that is where the business lies. They aren't going to get as far as they would like by having "their own labs" where all the specimens have to go, because that worsens turnaround time without gaining much advantage other than the size of the blood sample. And every time I read about this company I read about weak comparisons to current lab practice that only exist at terribly-run labs, like turnaround times of a week or drawing a quart of blood for a chemistry panel or charging $1000 for a lipid panel.

You may not have to get FDA approval for lab developed tests but you still have to show that they work!

Of course, some of this may be lack of my understanding of the regulatory issues and maybe they are less clueless than I think. But this whole thing is weird. If it's the "same technology" why is it revolutionary? Because you need less blood? You don't need tons of blood now for these tests, you can run dozens of tests off of one vial, you don't need one vial per test. To be sure, different tests have different collection requirements (whole blood vs EDTA vs serum separator etc) and if her tests can do everything off of one sample that is something of a revolution. But I am skeptical that it is such a distinct revolution and that what they can do is so unique to them that it will upend the industry.

What am I missing?
 
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WEBB PINKERTON

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Her quotes about peer reviewed studies not being needed were scary to me. Good ammunition to have if they try to take business. Hopefully she, and the others in her company who seem to have little understanding of regulations, will keep talking giving us more to use against them. What is dissapointing are the journalists, who don't seem to be critical enough of this company. Quit trying to make this lady into Steve Jobs or Marissa Mayer. Of course Steve Jobs just copied technology from Xerox and others and was still called revolutionary.

The only business they get will be their minute clinic patients.

You aren't missing anything.
 
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Their big thing is in price benefits. I am very surprised no-one mentions this. They have all their prices on their web site. http://www.theranos.com/test-menu?ref=for_providers This is huge! Most labs, you can't get a price for anything until after they bill insurance (and heaven help you if you don't have insurance).

The point here (as far as I can tell) is to dramatically reduce the cost of getting a large battery of bloodwork tests. This helps quite a bit with diagnosing...then if you aren't confident of Theranos' results you can get the results confirmed with a more established lab.

For patients with insurance with low deductibles or beyond their deductibles and going to hospitals with in-house labs, this doesn't really matter. But for the rest of the world, this is a help. Sure, not revolutionary, but definitely helpful. If they ever get it approved for patients to order on their own, that might shake things up a bit.

I can't imagine it displacing pathologists. There is so much demand already, all this company is going to do is take a little off the low-hanging case load.

If nothing else, think of it as enabling inexpensive routine bloodwork for borderline patients. Hell, I'd order a metabolic panel on my birthday every year just to complement my physical.
 

WEBB PINKERTON

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Some of us practice in states where Direct Access Testing is legal and our lab has it's DAT prices online. Come in, get a PSA test and pay us 30 bucks cash. No orders needed.

About half the states allow DAT at the moment and some only allow DAT with limitations. I guess I could see Theranos carve out a niche where it is legal. I'm not a fan of DAT but if everyone around you is doing it, then you end up jumping in as well.
 

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There's an article on them in Clinical Laboratory News this month. Interestingly there's also an article on the FDA and LDTs (which is going to make my life a nightmare if they do what it seems they're planning on doing, which seems to be defining anything that's now considered an FDA modified test by CLIA standards an LDT by FDA standars...)

But apparently Theranos is CLIA certified, so they'd better be following CLIA guidelines for method validation. It also says it's working on getting clearance by FDA.

http://www.aacc.org/publications/cln/2014/november/Pages/Elizabeth-Holmes.aspx

I believe the print article I have on my desk is quite a bit longer than this one and she talks quite a bit more and refers to Theranos as a reference lab, which kind of defeats the purpose of the supposedly fast turn around time. On that note, most of the issues with turn around time for our tests at least are pre-analytic and post analytic as far as those results getting to the patient. She's talking in terms of a couple of hours. The longest test in my lab takes about 40 minutes, most things are 10 or 15 on the analyzer and we have somewhere in the vicinity of 150 tests on our menu.
 

LADoc00

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Can we have an SDN volunteer apply and get the Theranos medical director job?

P.S. I love their marketing crap oh and by the way having your specimens read by someone of sheer awesomeness of the caliber of LADOC is also your GOD GIVEN RIGHT!

:zip:
 

WEBB PINKERTON

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Another article about these guys.

Bill Frist (a former Republican senator) remember him? is on the board. Gotta love his quote here:

The blood-test business is “dictated by the people who make the big machines,” Frist said, and they “obviously have a vested interest in keeping their technology out there.” He added, “You don’t need four tubes of blood” for a range of tests, or “this 1940 technology.”

http://www.newyorker.com/magazine/2014/12/15/blood-simpler?mbid=rss

I wonder if anyone with Theranos has actually been in a modern lab....Article says Theranos is going to need to build many laboratories, hire couriers, build infrastructure etc...Good luck with that.
 

pathstudent

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Wow she is an impressive young woman. College drop out to worth 4.5 Billion in ten years is something else. I wonder if she needs a boyfriend.
 

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He added, “You don’t need four tubes of blood” for a range of tests, or “this 1940 technology.”
You need those four tubes of blood because different tests require the blood preserved in different ways, and because inevitably the doc will call hours or days later to add on tests or send out for more obscure tests. Each individual test probably uses the same blood volume per test that Theranos is bragging about.
 

yaah

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I wonder if anyone with Theranos has actually been in a modern lab....Article says Theranos is going to need to build many laboratories, hire couriers, build infrastructure etc...Good luck with that.
Yeah, I know. They basically are building a lab business with different instruments, slightly less blood, and probably equivalent (or worse given need for couriers) TAT for the majority of tests. REVOLUTIONARY.

If the machines truly are revolutionary they would most likely be offered to all labs, not just Walgreens.
 

Granular

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Yeah, I know. They basically are building a lab business with different instruments, slightly less blood, and probably equivalent (or worse given need for couriers) TAT for the majority of tests. REVOLUTIONARY.
Not to mention lower sample quality from milking the drop of blood from the fingertip.

Also, their very first test on the test menu is "ABO/RhD Blood Typing." Would any blood bank accept the ABO results of a LDT, unpublished method, drawn at Walgreens? I know we would need a confirmatory sample, but would anyone actually count the Theranos' result as the initial type? They seem to have very limited medical guidance in what they are doing. Or they don't heed what their medical staff is telling them.
 

WEBB PINKERTON

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Not all of their tests are being run off of the blood from the fingertip. They are doing venous draws (using phlebs) on about 25 percent of their tests according to an article I read. If you read patient experiences, they were surprised they had to have a conventional blood draw.

I hope the people working there keep speaking to the media. It's more ammunition to use IF they ever show their face in your local Walgreens. They are not one of the disruptive technology companies that would keep me up at night if I were a younger pathologist.