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Thread: Breakthrough Of Instant Diagnosis

  1. #1
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    Default Breakthrough Of Instant Diagnosis


    Elizabeth Holmes: The Breakthrough of Instant Diagnosis

    A Stanford dropout is bidding to make tests more accurate, less painful—and at a fraction of the current price.

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    Palo Alto, Calif.
    'The reality within our health-care system today is that when someone you care about gets really sick, by the time you find that out it's most often too late to do anything about it. It's heartbreaking. Because in those moments, there's nothing you wouldn't do to change it, and too often you're helpless," says Elizabeth Holmes. "We're finding cancer when you have a tumor, or heart disease by virtue of the fact that you're having a heart attack."
    She wants to change that.
    Ms. Holmes, a 29-year-old chemical and electrical engineer and entrepreneur, dropped out of Stanford as an undergraduate after founding a life sciences company called Theranos in 2003. Her inventions, which she is discussing in detail here for the first time, could upend the industry of laboratory testing and might change the way we detect and treat disease.
    Ten years ago, Ms. Holmes was working out of the basement of a group college house, a world away from her current headquarters at a rambling industrial building in a research park just off campus. The company's real estate was one of the few Theranos facts known to Silicon Valley, but one suggestive of the closely held business's potential: The space was once home to Facebook, and before that Hewlett-Packard.
    The secret that hundreds of employees are now refining involves devices that automate and miniaturize more than 1,000 laboratory tests, from routine blood work to advanced genetic analyses. Theranos's processes are faster, cheaper and more accurate than the conventional methods and require only microscopic blood volumes, not vial after vial of the stuff. The experience will be revelatory to anyone familiar with current practices, which often seem like medicine by Bram Stoker.
    Enlarge Image






    Fred Harper


    A Theranos technician first increases blood flow to your hand by applying a wrap similar to one of those skiing pocket warmers, then uses a fingerstick to draw a few droplets of blood from the capillaries at the end of your hand. The blood wicks into a tube in a cartridge that Ms. Holmes calls a "nanotainer," which holds microliters of a sample, or about the amount of a raindrop. The nanotainer is then run through the analyzers in a Theranos laboratory. Results are usually sent back to a physician, but a full blood work-up—metabolic and immune markers, cell count, etc.—was in my inbox by the time I walked out the door. (Phew: all clear.)
    It's the kind of modern, painless service that consumers rarely receive in U.S. health care, though Ms. Holmes makes the point the other way around: "We're here in Silicon Valley inside the consumer technology world . . . and what we think we're building is the first consumer health-care technology company. Patients are empowered by having better access to their own health information, and then by owning their own data."
    And a Theranos clinic may be coming soon to a pharmacy near you. On Monday the company is launching a partnership with Walgreens for in-store sample-collection centers, with the first one in Palo Alto and expanding throughout California and beyond. Ms. Holmes's long-term goal is to provide Theranos services "within five miles of virtually every American home."
    Diagnostics is one of those corners of the health markets that is more irrational the closer you look. Tests account for between 2% and 2.5% of health spending, but Ms. Holmes notes that they drive an estimated seven or eight of every 10 clinical decisions by physicians, with 6.8 billion lab tests annually in the U.S.
    "The art of phlebotomy originated with bloodletting in 1400 B.C. and the modern clinical lab emerged in the 1960s—and it has not fundamentally evolved since then," she says. The billions of tests generally follow the same ritual: In a hospital or clinic, "you go in, sit down, they put a tourniquet on your arm, stick you with a needle, take these tubes and tubes of blood," as Ms. Holmes describes it.
    The specimens are then transported, via a courier or hospital pneumatic tube, to a centralized lab, where they are manually removed from the tubes with a pipette and mixed with a chemical reagent or sent through instruments like a centrifuge or mass spectrometer. After days or weeks of waiting, your doctor finally gets the results.
    One major problem, Ms. Holmes says, is that physicians rarely have "the best actionable information to make the best possible diagnosis at the time it matters." She posits a hypothetical patient whose doctor orders a test and discovers that she has a dangerously low hemoglobin count, so he puts her on an anti-anemia drug. He must order another test to find out what kind of anemia she has, and days later it turns out to be merely an iron deficiency. The best final treatment was actually "take some iron pills or eat more spinach."
    Theranos's technology eliminates multiple lab trips because it can "run any combination of tests, including sets of follow-on tests," at once, very quickly, all from a single microsample. Ms. Holmes estimates that patients and doctors will receive readouts in "as little as two hours" and can even do so before an office visit based on their physician's recommendation for better, or at least less ad hoc, consultations.
    Only about 62% of tests that doctors order are ultimately carried out, according to health-policy researchers at the Lewin Group. One reason tests aren't performed: not enough blood. To ensure that labs don't reject samples, several studies have documented that medical institutions sometimes collect as much as 45 times the amount of blood from patients that conventional tests actually require.
    Luckily, blood is a renewable resource, though the small Theranos sample size is a particular advance for the elderly, for whom blood draws can be agony because of collapsed veins. It's also good news for children who fear needles, and for oncology patients, whose blood is being constantly tested.
    Another Theranos advance is its testing's accuracy. Ms. Holmes believes the chain of conventional laboratory custody introduces too many opportunities for error, "which is basically wherever humans are involved." The integrity of lab specimens can be contaminated if they sit too long on the bench, or if they're mistakenly processed by a tech, or by temperature, and so forth.
    A 2002 review in the journal Clinical Chemistry found error estimates ranging from one out of every 33-50 tests to one of every 8,300, though the rate has likely since improved. The same sample sent to two different labs can yield two varying results, and the same lab testing the same sample twice can yield different results too.
    That's because the precision of lab instruments, and their reference ranges, vary from manufacturer to manufacturer. Labs buy from different vendors and often don't calibrate the machines to each other. Certain tests may be reported with fairly wide margins of error, such as a plus-or-minus 30% of allowable error for HDL cholesterol. Ms. Holmes notes that a measurement that is essentially a 60% error range isn't very useful, especially over time, since disease itself is a progression over time.
    Theranos's technology is automated, standardized, and attempts to subtract human error from the process. It can thus achieve much lower variance ranges for a given test. Ms. Holmes says its tests have margins of "allowable error" targets less than 10%.
    The medical promise of this speed and better information means catching disease in its earliest stages before the onset of symptoms. The company's analytic tools might also help realize the possibilities of truly personalized medicine, as scientists gain a better understanding of the heterogeneity of disease and how to treat individuals based on their own bodies, not large averages.
    Theranos's tools may also allow doctors to analyze data "longitudinally"—to see trends, clusters and rates of change that they can't now. Medicine would ask fewer on-off, do-you-have-this-disease-or-not questions, and instead "meaningfully and powerfully answer the question of how to detect and manage these diseases early on," says Ms. Holmes.
    She first funded Theranos at age 19 by cashing out an education trust that her parents set up, which allowed her to hire her first employee and rent lab space. Later rounds of funding were raised from venture capital and private equity. Once Theranos was more established, it started to earn revenue from contracts conducting pharmaceutical testing in cancer drug and other clinical trials.
    A word about costs and what that investment bought, which doesn't follow the usual rules about a new medical technology. Ms. Holmes says Theranos can conduct a battery of tests for "tens of dollars," a phrase that does not exist in U.S. health care. She calls it "a watershed opportunity to change the trajectory of health costs through price transparency."
    Since 1984, the Medicare Clinical Laboratory Fee Schedule has set reimbursements for 1,140 unique lab tests across 57 U.S. jurisdictions. That's 64,980 different price controls. Meanwhile, the prices that private insurers negotiate with providers are virtually trade secrets.
    Theranos is committing to a half-off discount on Medicare fees. "So a test that costs $100 now, we'll do $50 or less. The quote-unquote payer community I don't think has ever seen someone walk in and say we want to bill you at less than you're willing to reimburse," she says. If this strategy succeeds in squeezing down prices—say, lowering testing as a share of total health costs to 1.5% from 2.3% now—it could save Medicare $61 billion over 10 years and Medicaid $96.1 billion, according to what Theranos calls a conservative estimate.
    Ms. Holmes says her larger goal is increasing access to testing, including among the uninsured, though she might also have a market-share land grab in mind. For instance, she says Theranos will publish all its retail prices on its website. The company's X-ray of self-transparency also includes reporting its margins-of-error variations online and on test results and order forms, which few if any labs do now.
    This strategy may be inviting a hell of a battle with the health industry, where the incentives are rigged against startups and the empire usually finds a way of striking back. Witness the medical-practice regulations that make medicine a cartel against competitors. Pathologists, lab scientists and technicians won't be pleased if their jobs go the way of travel agents.
    Ms. Holmes declines to discuss Theranos's future plans, though one may speculate. There could be military applications in the battlefield, especially given the numerous framed American flags across the Theranos office and the presence on its corporate board of retired Gens. Jim Mattis and Gary Roughead, former Defense Secretary Bill Perry and former Secretary of State George Shultz.
    The other obvious tech reality is that the devices keep shrinking, and over the last several years Theranos has been granted several patents for portable diagnosis system at the point of care. One of them even invokes—forget the iWatch—a wearable diagnostic device that would attach to the body with silicon microneedles "about the size of a human hair."
    The biggest question is whether Ms. Holmes has discovered one of those often promised, more often elusive disruptive innovations designed to cut costs while improving quality. In a conversation about a year ago, Secretary Shultz said Ms. Holmes could be "the next Steve Jobs or Bill Gates."
    When I put it to him again on my recent visit, he smiles slyly. "This is not the last thing she's going to invent or create."
    Mr. Rago is a member of the Journal's editorial http://online.wsj.com/article/SB1000...mod=hp_opinion










  2. #2
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    Default Re: Breakthrough Of Instant Diagnosis

    nice find/snag here, vt....

    Quote Originally Posted by vt/wsj



    ....
    'The reality within our health-care system today is that when someone you care about gets really sick, by the time you find that out it's most often too late to do anything about it. It's heartbreaking. Because in those moments, there's nothing you wouldn't do to change it, and too often you're helpless," says Elizabeth Holmes. "We're finding cancer when you have a tumor, or heart disease by virtue of the fact that you're having a heart attack."
    She wants to change that.

    Ms. Holmes, a 29-year-old chemical and electrical engineer and entrepreneur, dropped out of Stanford as an undergraduate after founding a life sciences company called Theranos in 2003. Her inventions, which she is discussing in detail here for the first time,
    could upend the industry of laboratory testing and might change the way we detect and treat disease.

    .....

    am beginning to think that the best way to create JOBS, fix the problems is to encourage more COLLEGE DROPOUTS
    (only 1/2 sarc)

    interesting stuff here tho....


    A Theranos technician first increases blood flow to your hand by applying a wrap similar to one of those skiing pocket warmers, then uses a fingerstick to draw
    a few droplets of blood from the capillaries at the end of your hand. The blood wicks into a tube in a cartridge that Ms. Holmes calls a "nanotainer," which holds microliters of a sample, or about the amount of a raindrop. The nanotainer is then run through the analyzers in a Theranos laboratory. Results are usually sent back to a physician, but a full blood work-up—metabolic and immune markers, cell count, etc.—was in my inbox by the time I walked out the door. (Phew: all clear.)

    It's the kind of modern, painless service that consumers rarely receive in U.S. health care, though Ms. Holmes makes the point the other way around: "We're here in Silicon Valley inside the consumer technology world . . . and
    what we think we're building is the first consumer health-care technology company. Patients are empowered by having better access to their own health information, and then by owning their own data."

    And a Theranos clinic may be coming soon to a pharmacy near you. On Monday the company is launching a partnership with Walgreens for in-store sample-collection centers, with the first one in Palo Alto and expanding throughout California and beyond. Ms. Holmes's
    long-term goal is to provide Theranos services "within five miles of virtually every American home."

    Diagnostics is one of those corners of the health markets that is more irrational the closer you look. Tests account for between 2% and 2.5% of health spending, but Ms. Holmes notes that they drive an estimated seven or eight of every 10 clinical decisions by physicians, with 6.8 billion lab tests annually in the U.S.
    "The art of phlebotomy originated with bloodletting in 1400 B.C. and the modern clinical lab emerged in the 1960s—
    and it has not fundamentally evolved since then," she says. The billions of tests generally follow the same ritual: In a hospital or clinic, "you go in, sit down, they put a tourniquet on your arm, stick you with a needle, take these tubes and tubes of blood," as Ms. Holmes describes it.

    The specimens are then transported, via a courier or hospital pneumatic tube, to a centralized lab, where they are manually removed from the tubes with a pipette and mixed with a chemical reagent or sent through instruments like a centrifuge or mass spectrometer.
    After days or weeks of waiting, your doctor finally gets the results.

    One major problem, Ms. Holmes says, is that physicians rarely have "the best actionable information to make the best possible diagnosis at the time it matters." She posits a hypothetical patient whose doctor orders a test and discovers that she has a dangerously low hemoglobin count, so he
    puts her on an anti-anemia drug. He must order another test to find out what kind of anemia she has, and days later it turns out to be merely an iron deficiency. The best final treatment was actually "take some iron pills or eat more spinach."
    .......

    Only about 62% of tests that doctors order are ultimately carried out, according to health-policy researchers at the Lewin Group. One reason tests aren't performed: not enough blood. To ensure that labs don't reject samples,
    several studies have documented that medical institutions sometimes collect as much as 45 times the amount of blood from patients that conventional tests actually require.

    ....
    A word about costs and what that investment bought, which doesn't follow the usual rules about a new medical technology. Ms. Holmes says Theranos
    can conduct a battery of tests for "tens of dollars,"a phrase that does not exist in U.S. health care. She calls it "a watershed opportunity to change the trajectory of health costs through price transparency."

    Since 1984, the Medicare Clinical Laboratory Fee Schedule has set reimbursements for 1,140 unique lab tests across 57 U.S. jurisdictions.
    That's 64,980 different price controls. Meanwhile, the prices that private insurers negotiate with providers are virtually trade secrets.

    Theranos is committing to a half-off discount on Medicare fees. "So a test that costs $100 now, we'll do $50 or less. The quote-unquote payer community I don't think has ever seen someone walk in and say we want to bill you at less than you're willing to reimburse," she says. If this strategy succeeds in squeezing down prices—say, lowering testing as a share of total health costs to 1.5% from 2.3% now—
    it could save Medicare $61 billion over 10 years and Medicaid $96.1 billion, according to what Theranos calls a conservative estimate.

    Ms. Holmes says her larger goal is increasing access to testing, including among the uninsured, though she might also have a market-share land grab in mind. For instance, she says Theranos will publish all its retail prices on its website. ....

    This strategy may be inviting a hell of a battle with the health industry, where the incentives are rigged against startups and the empire usually finds a way of striking back. Witness the medical-practice regulations that make medicine a cartel against competitors. Pathologists, lab scientists and technicians won't be pleased if their jobs go the way of travel agents.
    just hope they (along with the med-ins-legal-drug mob, never mind with the medicare/caid-industrial complex dont find some way to....
    uhhhh...
    make her behave (or 'somehow' have an accident...)

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    Default Re: Breakthrough Of Instant Diagnosis

    This would be a godsend! I'm one of those "for whom blood draws can be agony because of collapsed veins."

    Currently, my doctor demands "routine bloodwork". The technicians can't get it because my veins are just too bad. The doctor won't prescribe my necessary thyroid meds without lab results. So I buy my thyroid pills without an Rx from a supplier in another country, and make my best guess as to dosage. My doctor then scolds me for treating myself. So I stop going to the damn doctor. Then "for my protection" the FDA bans the import via mail of my pharmaceutical-grade thyroid meds. I have to jump through all sorts of shady hoops to stay alive.

    Then there's the cost. After paying my atrocious monthly insurance premium, I can't afford to see a doctor or pay for my labs out of pocket until I meet my high deductible. The only place where I can have a successful blood draw is a hospital, where they use an ultrasound machine to find a good vein. But I can't afford to go to the hospital. I can't afford any healthcare at this point.

    This new test would let me walk in to a Walgreen's and buy my own tests at a reasonable cost. Where do I sign up to invest?

    Can someone please send this story to EJ behind the paywall? He might find Theranos very interesting from an investment standpoint.

    Be kinder than necessary because everyone you meet is fighting some kind of battle.

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by shiny! View Post
    This would be a godsend! I'm one of those "for whom blood draws can be agony because of collapsed veins."

    Currently, my doctor demands "routine bloodwork". The technicians can't get it because my veins are just too bad. The doctor won't prescribe my necessary thyroid meds without lab results. So I buy my thyroid pills without an Rx from a supplier in another country, and make my best guess as to dosage. My doctor then scolds me for treating myself. So I stop going to the damn doctor. Then "for my protection" the FDA bans the import via mail of my pharmaceutical-grade thyroid meds. I have to jump through all sorts of shady hoops to stay alive.

    Then there's the cost. After paying my atrocious monthly insurance premium, I can't afford to see a doctor or pay for my labs out of pocket until I meet my high deductible. The only place where I can have a successful blood draw is a hospital, where they use an ultrasound machine to find a good vein. But I can't afford to go to the hospital. I can't afford any healthcare at this point.

    This new test would let me walk in to a Walgreen's and buy my own tests at a reasonable cost. Where do I sign up to invest?

    Can someone please send this story to EJ behind the paywall? He might find Theranos very interesting from an investment standpoint.
    I think you'll find more of these types of stories. I work in the IT industry and the capabilities of the cloud architecture, big data stores and new free/shareware software which can really take advantage of it all is really opening up some new possibilities. I feel we are on the verge of another IT leap forward.....

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by jpatter666 View Post
    I think you'll find more of these types of stories. I work in the IT industry and the capabilities of the cloud architecture, big data stores and new free/shareware software which can really take advantage of it all is really opening up some new possibilities. I feel we are on the verge of another IT leap forward.....
    Man, I hope you're right, and that new technologies and business models will be able to overcome entrenched resistance.

    Be kinder than necessary because everyone you meet is fighting some kind of battle.

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    Default Re: Breakthrough Of Instant Diagnosis

    Yet, another cardboard cutout company suppoedly founded by the super-genius lone-dropout. How many more of these stories do we have to stomach. First, how much do you wanna bet that Ms. Holmes is linked to some pretty important people. Second, this system is being developed to support the people-identification and segregation systems planned for the future. No ID card will be needed, folks.

    If Ms Holmes wants to cure cancer, or a myriad of other diseases, all she has to do is educate the public on proper nutrition and protection from environmental toxins.

    Wait, but I thought it was only the lower uneducated classes that were subject to, and bought into, bread and circus?
    The greatest obstacle to discovery is not ignorance - it is the illusion of knowledge ~D Boorstin

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by reggie View Post
    Yet, another cardboard cutout company supposedly founded by the super-genius lone-dropout. How many more of these stories do we have to stomach. First, how much do you wanna bet that Ms. Holmes is linked to some pretty important people. Second, this system is being developed to support the people-identification and segregation systems planned for the future. No ID card will be needed, folks.
    Reggie, seriously has your view become so distorted that you can't recognize that technology can perform simple screening tests so much more efficiently and cheaper than current practice, and give much clearer results to patients than a lot of doctor speak? It's not for everyone, but is a major step towards bringing a portion of the healthcare costs down while improving service as well. BTW, another huge problem is that so many people are on so many medications that they are unable to keep track of them and are constantly over or under-medicating themselves or their loved ones. This problem is easily solved by real-time monitoring was well. God knows that there is plenty of reason to be paranoid when it comes to our privacy; but sometimes there can be some real benefits to giving up a bit of it. We just have to make sure the insurance companies don't have access; but then again if we had a single payer system even that would be a much smaller issue.

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    Default Re: Breakthrough Of Instant Diagnosis

    Sorry, but I don't see what is so magical here.

    Silicon chip-based tests are not a new idea. I don't know if that is precisely what Theranos is doing, but the silicon chip based tests are simply MEMS based tests which are fabricated by a semiconductor foundry as opposed to a test tube + chemical type setup - which is what most lab testing is now. The premise behind silicon chip based testing was that the automation and cost reduction would lead to far cheaper lab testing, as well as more consistent quality.

    The only wrinkle between a successful silicon MEMS test chip vs. Theranos would be the combination of multiple tests into a single 'system on chip'.

    Of course, the problem is that blood testing isn't generally as simple as testing pH in your pool. Often you have to do things like separate out specific components of blood, for example. Equally there are a lot of different tests that can be run - I think the number is well into the tens of thousands.

    Even a dramatic reduction of test costs for all of the above tens of thousands - I find it hard to see how it would be practical to automatically run all of the above tests in all cases - no matter how cheap each one might be. And one thing silicon MEMS based tests are not is flexible - you absolutely cannot tailor on the fly some subset in any way except by just cutting out the unwanted tests, but in this case the unwanted tests are manufactured (and thus paid for) already.

    Smells like a well paid PR effort to me.

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    Default Re: Breakthrough Of Instant Diagnosis

    Yeah, PR indeed, although to be fair, somebody has to commercialize the technology via a successful business, and getting the buzz going to open the funnels of investment is part of the process. micro-fluidics SoC solutions for bio analysis and detection have indeed been around for some time.

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    Default Re: Breakthrough Of Instant Diagnosis

    Could be hype, but am suspecting there is *something* there.

    I took a look at Glassdoor to see what the employees themselves are saying. Decent reviews and many seem to believe they are on a mission.

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    Quote Originally Posted by ltullos View Post
    Reggie, seriously has your view become so distorted that you can't recognize that technology can perform simple screening tests so much more efficiently and cheaper than current practice, and give much clearer results to patients than a lot of doctor speak? It's not for everyone, but is a major step towards bringing a portion of the healthcare costs down while improving service as well. BTW, another huge problem is that so many people are on so many medications that they are unable to keep track of them and are constantly over or under-medicating themselves or their loved ones. This problem is easily solved by real-time monitoring was well. God knows that there is plenty of reason to be paranoid when it comes to our privacy; but sometimes there can be some real benefits to giving up a bit of it. We just have to make sure the insurance companies don't have access; but then again if we had a single payer system even that would be a much smaller issue.
    What's disappointing here is that only the authorized communication is approved for discussion. Alternative views are derogatorily labelled. In this case, the non-authorized vector of dicussion is called "distorted" in order to thwart any further consideration of this view. Any other member who decides to follow-up on this vector can expect the same treatment, so the discussion is shut down. What a shame.

    As as side note, have you ever wondered why it is that there seems to be a high correlation between Harvard, Stanford and MIT drop outs - who create multi-billion dollar global corporations that alter society overnight - and military industrial complex funding levels of these same academic institutions.

    On another note, I completely agree with you on the desire to create "real-time monitoring", which most certainly will be deployed to tighten the fidelity of health care's feedback loop - don't take your meds, they'll be an automated system which will dose you "appropriately". Jesus Christ, is everyone so invested in this Simulacrum that the obvious trajectory of these systems is not only unseen, but not discussed as well? And I'm the one who is being called "distorted"?
    Last edited by reggie; 09-10-13 at 09:45 PM.
    The greatest obstacle to discovery is not ignorance - it is the illusion of knowledge ~D Boorstin

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by jpatter666 View Post
    Could be hype, but am suspecting there is *something* there.

    I took a look at Glassdoor to see what the employees themselves are saying. Decent reviews and many seem to believe they are on a mission.
    Read the reviews from some of the people who have interviewed there.
    The greatest obstacle to discovery is not ignorance - it is the illusion of knowledge ~D Boorstin

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by reggie View Post
    Read the reviews from some of the people who have interviewed there.
    In 2001 I attended a presentation by Francis Collins, leader of the Human Genome Project and currently Director of the National Institutes of Health. He made some very intriguing predictions regarding the power of genetic information to improve our understanding of the molecular basis of human pathology and as a result the efficiency of treatments. If I recall correctly, he had a 10ish year time frame in mind. As usual, an overly optimistic timeframe for biomedical research evolution. That said, the current advancing state of big data technology and high throughput molecular screening suggest that some changes may be in the offing.

    I think that the whole field of Personalized Medicine is going to matter. I wouldn’t necessarily hazard a guess on timing but there is a lot of progress achieved since the Francis Collins presentation in 2001.

    It is likely that these advances will influence the cost structure of medicine in the U.S. in the years to come. Exactly how remains to be seen but given the huge liability that is healthcare costs, people may want to spend some time building an understanding of the basics.

    Here are some presentations to help.

    Eight high level speakers (bottom left of page) from the Personalized Medicine World Conference – 2011.
    http://pmwcintl.com/

    Moderator Kevin Davies, author of The $1,000 Genome and editor-in-chief of BioIT World discusses personalized medicine and big data analytics in healthcare with Colin Hill, CEO of GNS Healthcare, Eric Schadt, PhD, Chief Scientific Officer Pacific Biosciences and Felix Frueh, PhD, President of Medco Research Institute.
    http://www.youtube.com/watch?v=bj8WXFP6ujc

    Howard Jacob speaking on Personalize Medicine at the Illumina Meeting in Feb. of 2013.
    http://www.youtube.com/watch?v=WUQ_qVe9HGQ

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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by Bundi
    I think that the whole field of Personalized Medicine is going to matter.
    The question is - will it matter to society overall or will it matter just to the 1%?

    One of the fundamental conflicts of profit driven medicine is that it is profit driven. That's why there are billions spent for developing and then using Viagra but far, far less spent to figure out how to handle malaria.

    Is there any reason to think this dynamic won't also affect Personalized Medicine?

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    Quote Originally Posted by c1ue View Post
    The question is - will it matter to society overall or will it matter just to the 1%?

    One of the fundamental conflicts of profit driven medicine is that it is profit driven. That's why there are billions spent for developing and then using Viagra but far, far less spent to figure out how to handle malaria.

    Is there any reason to think this dynamic won't also affect Personalized Medicine?
    I suspect the 1% will fare best in future medical care scenarios. It is certainly possible that any efficiencies that can be derived from “personalized medicine” (warning, buzz word) may simply result in a new value chain structure and a shift in economics to different concentrated players as opposed to lower costs to consumers or to an increased emphasis on previously underserved (lack of profit opportunity) therapeutic areas.

    I would not necessarily say that is the only possible outcome however. In other words, I don’t know that it is an either/or future.

    An important reality to consider is that big pharma R&D efficiency has lagged for many years now. This is to a meaningful degree because of the lack of new drug targets available to traditional drug discovery approaches. Long story short, there are simply way too many misses compared to wins in drug discovery and the cost is the same or similar in either case. In addition many of the new drugs coming to market are one offs of existing well established mechanisms of action addressing the same exact protein target, typically in a well-trodden mass market with a well-known regulatory pathway. While this is certainly not always the case, it has too often been true that the game is to get an approval and apply mass marketing to gain share. Hardly a winning formula for the industry, especially once generic competition enters a mass market and the efficacy of the branded drugs are marginally, if at all better. Big pharma is acutely aware of the problem and has been for years, so is adjusting.

    To your point, there are quite a few diseases with patient populations that simply lack sufficient numbers (or economic clout) to justify all of the R&D expense associated with finding the needle in the haystack treatment. This may be changing, grudgingly and on a disease by disease basis. The idea being that a larger and more nuanced set of data, measuring underlying molecular pathology over the time course of disease progression can be leveraged to identify a more specific cause or multi-factor profile of the disease. Couple this massive data set with an informatics platform capable of providing advanced analytics and some important correlations may be established between genetic profiles, protein physiology, and clinical outcomes. The hope is that in doing so, new and highly specific drug targets are revealed which would increase the likelihood of a drug discovery program yielding a win as opposed to a costly loss. It may also lower the cost of the winning program relative to what it otherwise would have been as well as yield a higher efficacy in the appropriate patient population.

    In theory anyway, this is a productive advance that could lower cost barriers to pursuing currently underserved diseases. I think this is where I find some hope. If diagnosing, characterizing, and treating disease can be done in a more efficient/productive manner perhaps there are benefits to be had even if they are not evenly distributed throughout society.

    The impact of any of this on big pharm business models is a very interesting topic and one that is being wrestled with by all players.

    As an aside, Viagra was originally intended to address hypertension. Interesting story here. http://www.about-ed.com/viagra-history
    Last edited by Bundi; 10-08-13 at 12:36 PM.

  16. #16
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    Default Creative Destruction? Let's hope so!

    Quote Originally Posted by vt View Post



    She calls it "a watershed opportunity to change the trajectory of health costs through price transparency."
    Since 1984, the Medicare Clinical Laboratory Fee Schedule has set reimbursements for 1,140 unique lab tests across 57 U.S. jurisdictions. That's 64,980 different price controls. Meanwhile, the prices that private insurers negotiate with providers are virtually trade secrets.
    Theranos is committing to a half-off discount on Medicare fees.
    This strategy may be inviting a hell of a battle with the health industry, where the incentives are rigged against startups and the empire usually finds a way of striking back. Witness the medical-practice regulations that make medicine a cartel against competitors. Pathologists, lab scientists and technicians won't be pleased if their jobs go the way of travel agents.




    I hope this works as claimed, and it can work on detect infections as well as endogenous illness.

  17. #17
    bill is offline iTulip Select Premium Member, Next Bubble Stocks Master
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    Default Re: Breakthrough Of Instant Diagnosis

    Thanks for posting.
    Credit to Ron Leuty
    http://www.bizjournals.com/sanfranci...into-view.html
    9-13-2013Silent, growing Theranos Inc. is public with its big plans.
    In a Wall Street Journal article last weekend, the Palo Alto company, which is developing a miniature medical device that can detect hundreds of diseases with a minute amount of blood, says it is opening in-store, sample-collection centers in Walgreens. It was scheduled to start Monday in a Palo Alto Walgreens, the Journal reported from its exclusive access to Theranos and CEO Elizabeth Holmes.
    We did our part to pull the covers back on Theranos — as far as we could without any cooperation from the company —
    http://www.bizjournals.com/sanfranci...=image_gallery

    http://www.flickr.com/photos/depsecdef/8660144172/

    http://www.bizjournals.com/sanfranci....html?page=all

    http://www.bizjournals.com/sanfranci....html?page=all


    Elizabeth Holmes has a compelling story to tell.
    Leaving Stanford University in 2003 at the urging of her mentor, the 19-year-old chemical engineering major started a company to develop her idea for a hand-held medical device, one that could read a minute amount of blood and produce a real-time assessment of how a drug is interacting with the body.
    In the decade since, Holmes has surrounded herself with a cast of technical experts and a board of business, political and military heavyweights, while amassing roughly $100 million from top-drawer investors.
    The result? Holmes’ company, Theranos Inc., stands on the cusp of unleashing a revolution in drug development and home health care that could spawn a new industry, much like the Bay Area’s Genentech Inc. did in biotech, Facebook Inc. did in social media and Apple Inc. did for personal computing. In the process, Theranos and its technology threaten to turn the business of consumer laboratory testing upside down.
    But it’s a story Holmes and Theranos have little interest in telling. Instead, the story of Theranos is one of extreme stealth and closely guarded secrets.
    The Palo Alto-based company operates from two large campuses with little signage to identify the company inside. It doesn’t talk to the media. Its bare-bones website was recently reworked, but contains little information apart from director biographies and job listings. When it leased its Newark campus last year, city officials, real estate brokers and others involved were sworn to secrecy on details of the transaction, even holding the tenant’s name in confidence.
    Legal documents from court cases involving Theranos explain the stealth as a strategy to keep potential competitors in the dark as it continues to develop a device that sensitively integrates chemistry, software, microfluidics and bio­mathematics.
    “The company’s culture is such that confidentiality is the essence of its existence,” Holmes, Theranos’ CEO, said in a declaration in one case.
    Most potential sources contacted for this story — Holmes, her Stanford professor mentor, Theranos employees, former employees, possible suppliers, scientific collaborators, possible competitors, defendants in lawsuits, board members and financial backers — either didn’t return phone or electronic messages, referred questions to Theranos or refused to comment on the record. Some cited sweeping nondisclosure agreements they had signed with the company.
    But despite the hush drawn around Theranos, its scale and scope hint at profound ambitions, and its pace of activity is quickening as it appears to move toward manufacturing its device.
    Theranos is ramping up hiring, has signed two huge leases in the past two years and has built a board with military and political clout. (See “Theranos Picks up the Pace” infobox.)
    Yet it all comes back to Holmes, the enigmatic powerpack at Theranos’ center.
    Over the company’s first decade, Holmes is the one constant. In that time, Theranos has raised millions of dollars — from the likes of Oracle Corp. CEO Larry Ellison and Menlo Park venture capital firm Draper Fisher Jurvetson — integrated nano, micro and biotechnologies into a consumer-friendly device, and battled insiders and outsiders threatening to disclose the company and its secrets.
    “I certainly went through a period where it became clear to me that, if I needed to, I would restart this company as many times as possible to make this thing happen,” Holmes said in a March 2009 lecture at Stanford, in one of her few public comments since the company’s inception. “And having that level of conviction makes it not about the money or the people or the title or the role.”
    Feeling right
    By the time Texas-born Holmes dropped out of college as a sophomore, she already had built an enviable résumé. She spent many of her teenage years in China (she speaks Mandarin) and started a company that sold software to Asian universities, according to lectures and a single radio interview given by Holmes and the websites hosting those talks. She also worked in a Singapore lab, helping to develop a novel protein microarray — essentially a lab on a chip — for detecting the deadly SARS virus.
    Holmes had little background in biology when she started the job in Singapore but quickly determined that the tools and technologies that microarrays used to detect blood components, or analytes, were outdated.
    Once she returned to Stanford, she said in the lecture, she “begged” her way into various labs to learn how to integrate microfluidics, the same technology used in inkjet printing.
    “When I would work on this, I felt like I was doing what I was supposed to be doing,” Holmes recalled in her Stanford lecture, “so it didn’t take very long for me to decide that this was what I wanted to go do.”
    (The video is one of four outside presentations or articles archived on Theranos’ website — none since 2010.)
    That work ultimately led to the formation of Theranos.
    “I wasn’t going to my classes, and I was spending all of my time talking to VCs, and then logistically (classes) just seemed like a waste of money,” Holmes recalled.
    What Holmes envisioned — and what Theranos engineers, an outside design consultant and others ultimately built — was a hand-held device. The device has gone through many changes, but it basically uses a micro­needle to take a very small sample of blood, run a chemistry lab in its cartridge and transmit the findings to patients, doctors, or — in the case of a clinical trial — a drug-development company and researchers. The cartridge is key, allowing users to target certain biomarkers by changing out that piece.
    The turnaround time for getting critical health data is not only quicker than the three days or so available through central labs — like those run by Quest Diagnostics Inc. or Laboratory Corp. of America — but higher quality and more predictive of a drug response, Holmes said in her Stanford lecture.
    The speed of the Theranos system could help drug-development companies, for one, save time and money and get the right drugs to the right patients at the right time — a cornerstone of the personalized medicine movement.
    Holmes led Theranos through three separate financings, raising about $50 million from December 2004 through December 2006, according to an August 2007 complaint Theranos filed in Santa Clara Superior Court against three former employees it accused of misappropriating trade secrets.
    Theranos said in a July 2010 filing with the Securities and Exchange Commission that it had raised $45 million from a single, unidentified investor.
    Yet while Theranos still doesn’t appear to have a mass-market commercial product, it may have a head start against potential competitors — and its hush-hush corporate mindset is designed to keep it that way.
    ‘Most secretive company’
    Theranos wanted to “maintain and extend” its lead in developing its system by “operating deeply in ‘stealth mode,’” the company’s complaint against the three former employees said. In fact, Holmes said in a declaration in the 2007 lawsuit that she and other Theranos managers “regularly and routinely communicated and continue to communicate to all Theranos employees … that Theranos wanted to avoid at all cost any interaction with or disclosure of its efforts to any of its potential competitors or other investors who could fund a company copying our integration of such disparate technical expertise.”
    The case was dismissed at Theranos’ request in January 2009.
    “They’re the most secretive company I’ve ever dealt with,” said Terrence Grindall, community development director for Newark, where Theranos leased space at the Pacific Research Center. “That’s not all bad. They said they have competitors and their technology is invaluable.”
    The company in July disclosed a makeover of its board of directors, with former Secretary of State George Shultz, Holmes and Theranos President and COO Ramesh “Sunny” Balwani as the only holdovers.
    Among those who left are Robert Shapiro, the former chairman of drug company Pharmacia Corp. , venture capitalist Pete Thomas of Redwood City’s ATA Ventures — another early Theranos investor — and Channing Robertson, the recently retired Stanford chemical engineering professor who encouraged Holmes to start her company.
    The new board includes former Secretary of State Henry Kissinger, a retired four-star general and former Defense Secretary William Perry.
    Most companies seek to fill their boards with directors with a wide range of experience and expertise, said Steve Hobbs, a managing director who specializes in board composition at Protiviti, a risk and benefits consulting subsidiary of Menlo Park-based staffing firm Robert Half International Inc.
    Theranos’ board now consists mainly of directors with diplomatic or military backgrounds.
    “Maybe, collectively, these folks bring the experience (Theranos is) looking for,” Hobbs said.
    Upper-level directors like those on Theranos’ board can help raise money “but that’s not the key ingredient in fundraising,” Hobbs said. “But having a brand name on the board can help in the credentialing of the organization.”
    Theranos’ connections are deep. Perry, for example, was at an April meeting between Holmes and Deputy Defense Secretary Ash Carter, who visited with Silicon Valley tech companies, according to the department’s website.
    Theranos would not say whether Perry had joined the board by then.
    Yet despite its big names, revolutionary goals, groundbreaking technology and apparent ramp-up, Theranos continues to move stealthily. Requests to speak with Holmes or other executives, board members and the company’s financiers were consistently rebuffed, and the company declined to provide any answers to written questions.
    “We are not granting interviews at this time or providing information past what is currently available on our website,” a company spokeswoman said in an Aug. 15 email message. “As we have additional news to share, we will be sure to follow up with you directly.”
    Last edited by bill; 10-08-13 at 01:54 PM.

  18. #18
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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by reggie View Post
    What's disappointing here is that only the authorized communication is approved for discussion. Alternative views are derogatorily labelled. In this case, the non-authorized vector of dicussion is called "distorted" in order to thwart any further consideration of this view. Any other member who decides to follow-up on this vector can expect the same treatment, so the discussion is shut down. What a shame.
    Reggie, I assure you my post was not intending to shut down any discussion as I think this is why we all come here. I accept that my label of "distorted" was harsh; but it just struck me that your view had become too cynical. Personally, I'm a big believer in the power of data (used constructively) to effect change, and the state today is that most medical tests are obviously way too expensive and done too late to promote prevention. I've worked in the semiconductor industry for 39 years and in that time have had a front-row seat to the explosion in innovation that can only come from increasing the power of analysis exponentially even as the cost declines linearly. The main area of our lives that has been the least impacted by this has been our healthcare, but MEMs are now starting to revolution this as well - and I can say that from a front-row seat in the world's leading producer of MEMs devices. The ability to collect and correlate big data cheaply and continuously has the potential to improve early detection and prevention like nothing else can. However, what we absolutely must be on-guard against is who owns and has access to that data. My biggest fear is that the insurance companies will gain access and use it against us, which is one more reason we need to move to single payer system and take it out the hands of those with pure profit motives. Finally, I would just add that I've done no research into Theranos or Elizabeth Holmes, and therefore have no opinion on the credibility of her or the company; but I do fully believe that they are targeting the right area to make real breakthroughs and to dramatically lower the cost and improve the value of diagnostic monitoring and testing. Again, sorry for offending you in my original post; and hope this opens the dialogue back up.

  19. #19
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    Default Re: Breakthrough Of Instant Diagnosis

    Quote Originally Posted by Bundi
    The idea being that a larger and more nuanced set of data, measuring underlying molecular pathology over the time course of disease progression can be leveraged to identify a more specific cause or multi-factor profile of the disease. Couple this massive data set with an informatics platform capable of providing advanced analytics and some important correlations may be established between genetic profiles, protein physiology, and clinical outcomes.
    As someone who follows Big Data - I can tell you that right now, Big Data is pretty much a buzzword on par with nano.

    Or in other words: hand waving, magical Wizard of Oz chicanery.

    In Auto Insurance, for example, the big to do has been about Progressive's Usage Based Insurance program via a device called Snapshot.

    The sales pitch is that Snapshot measures how safely you drive, and you get lower insurance as a result.

    But what does SnapShot actually do? It apparently collects only 3 pieces of data:

    1) Miles driven
    2) Times when driving
    3) Decelerations over a certain threshold

    1) is purely actuarial - you drive less, you should pay less insurance since your risk is less

    2) is measured purely as a function of how often you drive from the midnight to 4 am period. Certainly there are relatively more accidents in that time period due to drunken driving, but people working the night shift...too bad

    3) is equally problematic. If you are a jump on the accelerator/slam on the brakes type, this might make sense, but the threshold can as easily be triggered by your braking when some idiot cuts you off. I shudder to think what the results must be like in the places where people just aren't very courteous drivers.

    More worrisome - if in fact SnapShot only collects these 3 types of data, it seems more than slightly problematic that sufficient detail can be gathered to discover 'real' driving safety indicators. Snapshot also isn't 24/7/365 - you install it for 1 to 6 months, then send it back. Part of this is because I don't think anyone wants to be monitored full time - there just isn't any upside to it for the consumer - but the other part is that SnapShot is a GSM device attached to the car's OBDII port. The GSM requires a data plan, thus SnapShot costs Progressive a monthly fee which incidentally is charged to the consumer.

    Quote Originally Posted by bill
    Elizabeth Holmes has a compelling story to tell.
    Proof is in the pudding.

    After seeing any number of $100M companies fail - as well as succeed - secrecy is not a positive development.

    If Theranos in fact has such brainpower and a commanding lead in technology/development, secrecy beyond the most basic precautions is pointless.

    If, on the other hand, Theranos has a few tricks which anyone can replicate, then this doesn't make for a great company.

  20. #20
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    Default Re: Breakthrough Of Instant Diagnosis

    3) is equally problematic. If you are a jump on the accelerator/slam on the brakes type, this might make sense, but the threshold can as easily be triggered by your braking when some idiot cuts you off. I shudder to think what the results must be like in the places where people just aren't very courteous drivers.
    c1ue

    They could normalize the person's data to regional statistics.

    We already have this:

    1) if you go accident free for a few years, your rates go down.

    2) if You make any claim at all, your rates go up.

    I thought that the states had prevented insurance companies from offering too many discounts to good drivers, because, if you take this to extremes, it ceases to be insurance---ie everyone pay's their own costs.

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